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Clinical Medicine Research

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Part of the book series: Advances in Experimental Medicine and Biology (AEMB, volume 1116)

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Table of contents (12 chapters)

Front matter, bioprogressive paradigm in physiotherapeutic and antiaging strategies: a review.

• Mieczyslaw Pokorski, Giovanni Barassi, Rosa G. Bellomo, Loris Prosperi, Matteo Crudeli, Raoul Saggini

Influence of Proprioceptive Neuromuscular Facilitation on Lung Function in Patients After Coronary Artery Bypass Graft Surgery

• Małgorzata Bujar-Misztal, Andrzej Chciałowski

Remote Ischemic Preconditioning in Renal Protection During Elective Percutaneous Coronary Intervention

• Małgorzata Wojciechowska, Maciej Zarębiński, Piotr Pawluczuk, Dagmara Gralak-Łachowska, Leszek Pawłowski, Wioletta Loska et al.

Prognostic Impact of Extracapsular Lymph Node Invasion on Survival in Non-small-Cell Lung Cancer: A Systematic Review and Meta-analysis

• Seyed Vahid Tabatabaei, Christoph Nitche, Maximilian Michel, Kurt Rasche, Khosro Hekmat

Influence of Transurethral Resection of Bladder Cancer on Sexual Function, Anxiety, and Depression

• Wojciech Krajewski, Urszula Halska, Sławomir Poletajew, Radosław Piszczek, Bartosz Bieżyński, Mateusz Matyjasek et al.

Cognitive Predictors of Cortical Thickness in Healthy Aging

• Patrycja Naumczyk, Angelika K. Sawicka, Beata Brzeska, Agnieszka Sabisz, Krzysztof Jodzio, Marek Radkowski et al.

Osteoprotegerin, Receptor Activator of Nuclear Factor Kappa B Ligand, and Growth Hormone/Insulin-Like Growth Factor-1 Axis in Children with Growth Hormone Deficiency

• Ewelina Witkowska-Sędek, Małgorzata Rumińska, Anna Stelmaszczyk-Emmel, Maria Sobol, Urszula Demkow, Beata Pyrżak

Inhibition of Cross-Reactive Carbohydrate Determinants in Allergy Diagnostics

• Maciej Grzywnowicz, Emilia Majsiak, Józef Gaweł, Karolina Miśkiewicz, Zbigniew Doniec, Ryszard Kurzawa

Effects of Glutathione on Hydrolytic Enzyme Activity in the Mouse Hepatocytes

• Iwona Stanisławska, Bożena Witek, Marek Łyp, Danuta Rochon-Szmejchel, Adam Wróbel, Wojciech Fronczyk et al.

Adaptation to Occupational Exposure to Moderate Endotoxin Concentrations: A Study in Sewage Treatment Plants in Germany

• M. A. Rieger, V. Liebers, M. Nübling, T. Brüning, B. Brendel, F. Hoffmeyer et al.

Effects of Low-Level Laser Therapy in Autism Spectrum Disorder

• Gerry Leisman, Calixto Machado, Yanin Machado, Mauricio Chinchilla-Acosta

Epidemiology of Granulomatosis with Polyangiitis in Poland, 2011–2015

• Krzysztof Kanecki, Aneta Nitsch-Osuch, Paweł Gorynski, Patryk Tarka, Magdalena Bogdan, Piotr Tyszko

This book presents an update on new trends and developments in broadly defined medical disciplines. The whole range of multidisciplinary topics are tackled, regarded as being important for advancing the understanding of disease pathogenicity, diagnostic methods, and patient management. The topics include a holistic approach to physiotherapy, with proprioceptive neuromuscular facilitation at the core of it, potential ways to protect kidneys during ischemic coronary interventions, and psychosocial aspects in cancer survivors. Other topics deal with growth hormone deficiency in short children and responses of molecular markers of bone metabolism to growth hormone replacement therapy and with the modern use of transcranial laser-induced photobiomodulation showing surprising benefits in autism disorder. The expert contributions take on the challenges presented to medical professionals by ever growing medical knowledge and various individual and contextual issues that require a multidisciplinary approach in patient management. The authors present a bench-to-bed clinical research to make useful additions to the knowledge on contemporary diagnostic procedures, therapy, and quality of life of patients. The book aims to provide stimulus for new research ideas and to give new perspectives on practical clinical issues. The book is intended for primary care clinicians, family physicians, medical scholars, and other clinicians who treat and manage patients.

• Bioprogressive treatment
• Cancer research
• Cognitive function
• Coronary disease
• Diagnostic markers
• Growth hormone
• Health care
• Occupational endotoxins
• Physiotherapy

Mieczyslaw Pokorski

Book Title : Clinical Medicine Research

Editors : Mieczyslaw Pokorski

Series Title : Advances in Experimental Medicine and Biology

DOI : https://doi.org/10.1007/978-3-030-04837-2

Publisher : Springer Cham

eBook Packages : Biomedical and Life Sciences , Biomedical and Life Sciences (R0)

Copyright Information : The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2018

Hardcover ISBN : 978-3-030-04836-5 Published: 04 December 2018

eBook ISBN : 978-3-030-04837-2 Published: 23 November 2018

Series ISSN : 0065-2598

Series E-ISSN : 2214-8019

Edition Number : 1

Number of Pages : VI, 138

Number of Illustrations : 13 b/w illustrations, 6 illustrations in colour

Topics : Neurochemistry , Cancer Research , Physiotherapy , Cytokines and Growth Factors

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Bile acid malabsorption (BAM) is characterized by chronic watery diarrhea resulting from excessive bile acids in the feces. BAM is often an overlooked cause of chronic diarrhea, with its prevalence not being sufficiently researched.

The field of kidney transplantation is being revolutionized by the integration of artificial intelligence (AI) and machine learning (ML) techniques. AI equips machines with human-like cognitive abilities, while ML enables computers to learn from data.

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Clinical Research: An Overview of Study Types, Designs, and Their Implications in the Public Health Perspective

Venkataramana Kandi 1, and Sabitha Vadakedath 2

1 Department of Microbiology, Prathima Institute of Medical Sciences, Karimnagar, Telangana, India

2 Department of Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, Telangana, India

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Why diversity is needed at every level of clinical trials, from participants to leaders

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Diversity in clinical trials must be accompanied by justice and equity, including benefits for underrepresented participants, in order to boost population health.

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Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington (DC): National Academies Press (US); 2010.

Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary.

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2 The State of Clinical Research in the United States: An Overview

The Institute of Medicine (IOM) reports To Err Is Human: Building a Safer Health System ( IOM, 2000 ) and Crossing the Quality Chasm: A New Health System for the 21st Century ( IOM, 2001a ), focused the nation’s attention on concerns about the quality of health care in the United States. Since those reports were published, efforts have accelerated to develop a health care system that systematically measures and improves the quality of care delivered. Essential to such a system is a systematic approach for assessing which clinical approaches do and do not work and then ensuring that this knowledge is utilized in clinical decision making. This approach is what is often referred to as a learning health care system.

Many different kinds of evidence can inform the policies and practices of a health care system. Clinical trials, a type of clinical research, are one of the most robust sources of this knowledge. A number of workshop speakers from many backgrounds—clinical investigators, research sponsors, practitioners, and patients—expressed the view that the current clinical research enterprise 1 in the United States is unable to produce the high-quality, timely, and actionable evidence needed to support a learning health care system. They identified numerous obstacles to producing this evidence, including the length of time and high financial cost involved in conducting clinical trials, delays associated with navigating the many regulatory and ethical requirements of studies involving human subjects (e.g., Institutional Review Board [IRB] approval), difficulties in recruiting and retaining the appropriate patient population, and the generally fragmented way clinical research is prioritized and undertaken to advance medical care in the United States.

As noted in Chapter 1 , the workshop focused on the randomized controlled trial (RCT), the gold standard in clinical research. Many consider the RCT to be unsustainable as an approach to addressing the large number of research questions that need to be answered because of the time and expense involved. Yet alternative approaches have limitations with respect to producing high-quality data. Christopher Cannon, senior investigator in the Thrombolysis in Myocardial Infarction (TIMI) Study Group, for example, discussed the use of registries, which are large databases that provide extensive observational data on current clinical practice. He commented that while registry data are of good quality and less expensive to obtain compared with data from RCTs, confounding (i.e., why an individual received one therapy versus another) is a significant problem. Because it is difficult to attribute trends in registry data to particular therapies, registries do not provide the conclusive evidence necessary to change clinical practice. Instead, registries generate hypotheses that can then be tested in an RCT. Therefore, while patient registries and other research tools exist, the workshop focused primarily on RCTs.

Results of thousands of RCTs are published each year, yet clinical decision making frequently is not based on the evidence created by these results. A key issue informing the workshop discussions, then, was how RCTs can be conducted in an efficient, timely manner to answer all of the questions and meet all of the needs of a learning health care system. A logical first step in addressing this issue is to examine the clinical research enterprise as it operates in the United States today.

This chapter describes various aspects of clinical research in the United States, beginning with clinical research networks (CRNs). Research commissioned for the workshop from Ronald Krall, former Chief Medical Officer, GlaxoSmithKline, is then presented, addressing tools available for assessing clinical research in the United States; volume and type of clinical trials conducted; the clinical investigator workforce; and the overall capacity of the clinical research enterprise.

• CLINICAL RESEARCH NETWORKS

CRNs have been developed to pool resources and expertise in conducting clinical research. They include clinical sites and investigators usually organized around a specific disease area and can be accessed by many different research stakeholders for the conduct of clinical research.

The National Institutes of Health’s (NIH’s) Roadmap for Medical Research points specifically to CRNs and their ability to rapidly conduct high-quality studies as a way to improve the efficiency and productivity of the clinical research enterprise. In this vein, NIH’s National Center for Research Resources (NCRR) manages the Inventory and Evaluation of Clinical Research Networks (IECRN) project to survey active networks and characterize best practices that could potentially be implemented in other networks or clinical trial settings. Although the exact structures vary, the NIH project defines a CRN as an organization of clinical sites and investigators that conducts or intends to conduct multiple collaborative research protocols. CRNs can carry out a number of different types of studies, including clinical trials, and the organization of sites and investigators can be formal or informal as long as the collaborative accomplishments of the group are clear. For instance, a group of researchers that conducts a single trial and subsequently disbands is not considered to be a network ( NCRR, 2006 ).

By pooling the resources of multiple entities, CRNs can realize efficiencies in implementing and conducting clinical trials. They create a supportive infrastructure for investigators and can facilitate the rapid conduct of trials to answer important research questions. For instance, CRNs organized around a particular disease often have access to patients with that disease who can serve as study participants. The in-house scientific leadership of CRNs can also streamline the protocol development process and create uniformity in clinical trials across the network or disease area. When clinical trials from a particular network generate consistent results, this can also accelerate the drug development pipeline for the disease studied.

TOOLS FOR ASSESSING CLINICAL RESEARCH IN THE UNITED STATES 2

Krall obtained information on the current state of clinical trials in the United States from various public and private sources. A key source was data on submissions to clinicaltrials.gov, a federally sponsored, publicly available registry of clinical trials. Information was also obtained from the Tufts Center for the Study of Drug Development, KMR Group, Citeline, and individual pharmaceutical companies. The Tufts Center and KMR collect data from pharmaceutical companies for the purpose of providing benchmarking data and proprietary analyses. Citeline is a proprietary data source that draws from a number of resources (literature, advertising, and clinicaltrials.gov) to create a comprehensive database of clinical research and the global investigator workforce.

Clinicaltrials.gov

The Food and Drug Administration Modernization Act (FDAMA) of 1997 mandated the creation of the clinicaltrials.gov registry for efficacy trials in serious and life-threatening conditions and interventions regulated by the FDA. Developed by NIH’s National Library of Medicine (NLM) in 2000, it allows interested parties to find information on both completed and ongoing clinical trials. The database includes federally and privately supported clinical trials, and study sponsors are responsible for submitting timely and accurate information about their studies.

The database registered a modest number of clinical trials in its initial years ( Figure 2-1 ). A dramatic increase in trial registration came in 2005 in response to the newly introduced International Committee of Medical Journal Editors’ (ICMJE’s) requirement that studies published in their journals be registered in clinicaltrials.gov or other equivalent publicly available registries. The Food and Drug Administration Amendments Act (FDAAA) of 2007 created a legal requirement for the registration of trials of drugs, biologics, and devices, generating a modest increase in the registration of trials over what had been seen in 2005. Given the increasing number of trials registered on clinicaltrials.gov over time, the database encompasses a broad spectrum of research organized by study sponsor (industry, government, and nonprofit), disease and treatment being studied, and trial design.

Timeline reflecting the number of clinical trials registered on clinicaltrials.gov and regulatory changes affecting the database registration from 2001 to 2009. SOURCE: Krall, 2009. Reprinted with permission from Ronald Krall 2009.

Data Limitations

The information gathered by Krall to inform the workshop discussions of the state of the U.S. clinical research enterprise was not intended to provide an exhaustive analysis of the impact of every role and action of the broad range of research stakeholders involved. Rather, the goal was to highlight the productivity of one aspect of the clinical research enterprise—clinical trials. The data gathered reflect not the “effectiveness” of trials in terms of how well they answer the study questions, but how efficiently they are conducted. The commissioned research was designed to meet the needs of the workshop, however, the topics covered and issues raised by Krall’s analysis could be informative for other areas of the clinical research enterprise as well.

The data collected have some limitations. With respect to certain industry information, individual pharmaceutical company data can vary significantly depending on how the various elements and costs of clinical trials are measured. Also, although NLM reviews information submitted to the clinicaltrials.gov database, neither the accuracy of the data nor the scientific relevance of the study is guaranteed. Thus, while the information gathered on the number and type of clinical trials being conducted today is revealing, it would be incorrect to assume that it reflects the quality or relevance of those trials. Krall also noted that some types of clinical trials do not need to be reported to the database, and that there are concerns about the timeliness and accuracy of the data that are submitted. Variability in the reporting and classification of certain data elements in clinicaltrials.gov (e.g., drugs vs. biologics, phases of research, reporting no funding source, and currency of investigator site information) is another concern. Yet while clinicaltrials.gov is not without limitations, Krall suggested that its creation is undoubtedly a positive step toward developing a clearer picture of the state of clinical research in the United States.

• VOLUME AND TYPE OF CLINICAL TRIALS CONDUCTED

In RCTs, investigators control which participants receive the study treatment by assigning them at random to a particular experimental study group. Observational, non-experimental studies occur in natural settings and involve no manipulation of the interventions or treatments study participants receive. Because RCTs were the focus of the workshop, observational studies were excluded from Krall’s analysis.

Krall reported that as of August 16, 2009, there were 10,974 ongoing, interventional clinical trials with at least one U.S. center. The 10,974 ongoing trials collectively are seeking to enroll 2.8 million subjects. As Figure 2-2 indicates, the majority of trials (59 percent) are testing drugs. A distant second and third to drug interventions are behavioral trials (10 percent) and those testing biologics (9 percent), respectively.

Percentage of the 10,974 ongoing clinical trials and 2.8 million study subjects being sought by intervention being tested. SOURCE: Krall, 2009. Reprinted with permission from Ronald Krall 2009.

Clinical Trials by Phase of Research

The phase of clinical trials (i.e., phases 0-IV; see Chapter 1 ) is considered by some to be a marker of innovation, reported Krall. An analysis of clinical research by phase of experimental clinical trials can indicate the degree to which innovative new therapies are being developed and tested. It takes 10–15 years for a typical drug to be developed successfully from discovery to registration with the FDA. In the earlier phases of research, the chance of a drug reaching patients is small—approximately 1 in 10. In phase III research, however, the odds of registering a new product improve. About two-thirds of drugs that reach pivotal phase III trials will make it to the market ( IOM, 2009c . 85).

To characterize trials by phase more precisely, Krall narrowed the focus of his research to trials for FDA-regulated interventions (drugs, biologics, devices, and dietary supplements). In these FDA-regulated categories, there are 8,386 trials recruiting 1.9 million subjects. As shown in Figure 2-3 , among clinical trials for FDA-regulated products, phase II research is the largest category, followed closely by phase IV. Also referring to Figure 2-3 , although there are larger numbers of phase II and III trials, phase III trials by design involve the largest number of participants; thus it makes sense that 52 percent of all subjects are enrolled in these pivotal trials.

Number of the 8,386 clinical trials involving FDA-regulated products and 1.9 million study subjects being sought for these trials by phase of research. SOURCE: Krall, 2009. Reprinted with permission from Ronald Krall 2009.

Clinical Trials by Disease

Krall described ongoing clinical trials in the four disease areas of focus at the workshop—cardiovascular disease, depression, cancer, and diabetes. Figure 2-4 indicates that approximately half of the 10,974 trials being conducted today are in cancer; however, each such trial involves a relatively small number of participants. Figure 2-4 also reveals that cardiovascular disease trials are seeking more than 300,000 participants—10 percent of all clinical trial participants being recruited and far more than the number of participants sought for cancer, diabetes, or depression trials. Recruiting a large number of subjects per trial is a trademark of cardiovascular disease studies: on average, 275 patients are sought per cardiovascular trial, as compared with 20 patients per cancer trial, 70 patients per depression trial, and 100 per diabetes trial.

Number of the 10,974 ongoing clinical trials and 2.8 million study subjects being sought by disease being studied. NOTE: CV Disease = cardiovascular disease. SOURCE: Krall, 2009. Reprinted with permission from Ronald Krall 2009.

• THE CLINICAL INVESTIGATOR WORKFORCE

Annual surveys from the Tufts Center for the Study of Drug Development indicate a consistently high turnover rate in the clinical investigator community. Investigators conducting a clinical trial to support a New Drug Application (NDA) or a change in labeling are required to complete FDA’s Form 1527. In 2007, 26,000 investigators registered this form with the FDA, 85 percent of whom participated in only one clinical trial. The issues facing clinical investigators were discussed throughout the workshop, and many participants echoed the theme of the Tufts data—it is difficult to conduct clinical trials in the United States and establish a career as a clinical investigator. While opportunities in clinical investigation can vary depending on whether or not an investigator is working in private practice or academia, for example, the challenges to successfully conducting a clinical trial in the United States are substantial. Making clinical investigation an attractive career option for academics and professionals was mentioned by a number of participants as an important component of any approach to improving the capacity of the clinical trials enterprise in the United States.

Globalization

In addition to high turnover, the U.S. clinical investigator workforce is subject to an absolute decrease in its ranks. While there has been an annual decline of 3.5 percent in U.S.-based investigators since 2001, there has been an increase in investigators outside the United States. Figure 2-5 reveals that investigators from the rest of the world increased steadily between 1997 and 2007, making up for the decline in North American investigators over the same period. As of 2007, U.S. investigators constituted 57 percent of the global investigator workforce, a decrease from approximately 85 percent in 1997. According to the Tufts data, there are an estimated 14,000 U.S. investigators, compared with an estimated 12,000 investigators outside the United States. Currently, 8.5 percent of investigators are from Central and Eastern Europe, 5.5 percent from Asia, and 5.5 percent from Latin America.

The proportion of clinical investigators from North America has decreased since 1997, while the proportion of investigators from Western Europe and the rest of the world has increased. SOURCE: Tufts Center for the Study of Drug Development. 2009. Impact (more...)

Finally, Krall noted the difference between the role of a clinical investigator (i.e., the person who establishes the hypotheses to test, designs the trial, analyses and reports the results) and that of the individual who finds patients to participate in a trial and collects information about them. The latter role is essential to the ability to carry out research and should be recognized, rewarded, and developed to a greater degree, according to Krall. Workshop presenters and participants echoed Krall’s sentiment later in the day by discussing the many different levels of staff, in addition to the principal investigator, that ultimately make a clinical trial successful.

• CAPACITY OF THE CLINICAL RESEARCH ENTERPRISE

KMR data from 2006 for the 15 largest pharmaceutical companies show that the majority of patient visits associated with an industry-sponsored clinical trial occur outside the United States. According to Krall, this statistic speaks to the costs and difficulty associated with conducting clinical research in the United States. In terms of cost-effectiveness, 860 patient visits occur in the United States per $1 million spent on clinical operations, whereas for the same cost, 902 patient visits occur outside of the United States. Thus, by the measure of cost per patient visit, U.S.-based clinical trials are not as cost-effective as those in the rest of the world. Krall urged caution in interpreting these data, however, given the high degree of variability among pharmaceutical companies in patient visit and cost measures.

U.S. investigators enroll two-thirds as many subjects into clinical trials as investigators in the rest of the world. Among U.S. investigators participating in a clinical trial, 27 percent fail to enroll any subjects, compared with 19 percent of investigators elsewhere. Investigator performance in the United States and the rest of the world is similar in that 75 percent of investigators fail to enroll the target number of subjects; also, 90 percent of all clinical trials worldwide fail to enroll patients within the target amount of time and must extend their enrollment period. Krall commented that these data on patient enrollment are from one pharmaceutical company but that, based on his industry experience and conversations with colleagues from other companies, he believes the data are generally consistent with the pharmaceutical industry as a whole.

According to clinicaltrials.gov data, clinical trials today call for the enrollment of 1 in every 200 Americans as study participants. Because this is such a remarkable undertaking, Krall questioned whether this high level of human participation is being put to the best use possible—that is, are the right questions being asked through the thousands of clinical trials being conducted today?

The clinical research enterprise is a broad term that encompasses the full spectrum of clinical research and its applications. It includes early-stage, laboratory research and the processes, institutions, and individuals that eventually apply research to patient care ( IOM, 2002 ).

The remainder of this chapter is based on the presentation of Dr. Krall.

• Cite this Page Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington (DC): National Academies Press (US); 2010. 2, The State of Clinical Research in the United States: An Overview.
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Clinical Reasoning of a Generative Artificial Intelligence Model Compared With Physicians

• 1 Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts
• 2 Department of Medicine, Massachusetts General Hospital, Boston
• 3 Department of Pulmonary and Critical Care, Brigham and Women’s Hospital, Boston, Massachusetts

Large language models (LLMs) have shown promise in clinical reasoning, but their ability to synthesize clinical encounter data into problem representations remains unexplored. 1 - 3 We compared an LLM’s reasoning abilities against human performance using standards developed for physicians.

Read More About

Cabral S , Restrepo D , Kanjee Z, et al. Clinical Reasoning of a Generative Artificial Intelligence Model Compared With Physicians. JAMA Intern Med. Published online April 01, 2024. doi:10.1001/jamainternmed.2024.0295

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Precision Medicine for Parkinson’s Disease Is Focus of New Yale Center

Clemens Scherzer, MD , is on a mission to revolutionize the treatment of Parkinson’s disease through the use of genomics and artificial intelligence (AI) to create tailored therapeutics. In January, Scherzer joined Yale School of Medicine (YSM) and stepped into his new role as director of the Stephen & Denise Adams Center for Parkinson’s Disease Research. The center’s unique approach to developing the future of precision medicine for Parkinson’s disease is the first of its kind, he says.

“Right now, we wait for Parkinson’s disease to progress and cause debilitating symptoms that drive the patient to the clinic, where we scramble to catch up with treating them,” says Scherzer. “Through our new center, we want to learn to catch the disease early, be able to predict what the future will hold for each patient, and then intervene to prevent debilitating progression from ever occurring.”

Researchers will identify targets for new Parkinson’s disease medications

Scherzer envisions a future in which a person with Parkinson’s disease can walk into a clinic and provide a few drops of blood that a computer program can analyze to identify the patient’s genome and biomolecules. Clinicians would be able to use this information in addition to the patient’s electronic health data to determine the exact disease driver and to recommend precision therapeutics based on tailored biomarkers.

“Our work is similar to how a search engine targets advertisements to a user based on massive search histories,” he explains. “The goal is to precisely match the right drug to the right person at the right time, based on a search of the entire disease biology.”

To make this vision a reality, Scherzer and his team are building a multi-modal human atlas of Parkinson’s disease by cataloging molecular and clinical data from thousands of patients. Scherzer began this work while at Harvard Medical School, where he was professor of neurology, director of the American Parkinson’s Disease Association (APDA) Center for Advanced Parkinson Research, and director of the Precision Neurology Program at Brigham and Women’s Hospital. He will be advancing these efforts at YSM.

So far, Scherzer’s team has already sequenced the RNA programs of one million human brain cells spanning the entirety of disease progression—from healthy brains, to those in the earliest stages of Parkinson’s, to those in the most advanced manifestations of the disease.

Other ongoing work that also will be expanding at the Yale center includes the Yale Harvard Biomarkers Study, which involves mapping the genetic variants that control the course of Parkinson’s and using multi-omics technology to catalog molecules in patients’ biofluids. The biobank already has hundreds of thousands patient samples of DNA, RNA, plasma, and more—stored at the Yale Adams Center and with collaborators at Mass General Brigham—that he and his program have extensively characterized over several years as patients’ disease advanced. “This is a treasure trove for discovery of genes, therapeutics, and biomarkers,” says Scherzer.

The goal is to precisely match the right drug to the right person at the right time, based on a search of the entire disease biology. Clemens Scherzer, MD

For example, approximately 10% of patients with sporadic Parkinson’s disease [in which the patient has no clear familial history] have a mutation in a gene known as GBA . Researchers have discovered four different types of genetic variants of this gene that regulate the speed of progression of the disease. Those with the most severe mutation suffer a very rapid progression of their condition. After identifying this disease driver, a research team Scherzer led at Harvard collaborated with a pharmaceutical company to target this gene with precision medicine. The collaboration contributed to the first Phase 2 clinical trial focused on a genetic form of Parkinson’s and provided a tool kit for precision trials targeting GBA .

Scherzer hopes to use the power of genomics and AI to turn data into medicine. The center is using computational neuroscience and machine learning to accelerate research. “With powerful sequencing and computational technologies, we can look at 30,000 genes in a million brain cells in parallel and let biology tell us what is truly important to work on.”

Paving the way to precision medicine for Parkinson’s disease

Now, Scherzer’s ambitions include identifying other disease drivers and learning how to target them. “We’re on a quest to decode the RNA software of brain cells and figure out how to develop tailored drugs that correct any glitches,” he says. “Then, our goal is to launch early-stage clinical trials based on our newly identified drug targets.”

To fast-track drug development, the researchers are utilizing electronic patient data from entire populations and from their Yale Harvard Biomarkers Study to find old drugs that could be repurposed for Parkinson’s patients. In collaboration with the University of Bergen in Norway, Clemens’ team is using computer models to compare health outcomes recorded over a decade in thousands of individuals with Parkinson’s disease on a medication compared to millions of individuals with Parkinson’s not on the medication. “We are searching for old drugs that can be taught new tricks to help patients with Parkinson’s disease,” says Scherzer.

This search is identifying drugs for possible repurposing, including medications commonly used for asthma known as beta2 agonists. In the lab, the researchers observed that in neurons grown in a dish, the asthma drugs lowered the activity of the alpha-synuclein gene and improved the cells’ health. “This was intriguing because the brains of Parkinson’s patients are full of Lewy bodies, which are piles of alpha-synuclein,” says Scherzer. “Dialing down alpha-synuclein levels would be ideal to correct this disease driver.”

Several beta2 agonists are currently in clinical trials. Scherzer and colleagues hope that their repurposing platform will spur even more clinical trials.

A central goal of the Yale center is to develop new and more effective Parkinson’s disease medications that slow or block disease progression and prevent disabling symptoms from ever occurring. “We already have dopamine replacement medicines that treat patients very well for several years, but then debilitating complications develop,” says Scherzer. “If we can identify drugs that extend this therapeutic window for 10 years or more, many patients will never suffer these complications.”

His longer-term vision is to one day build a precision neurology clinic where those living with Parkinson’s disease receive personalized treatments. “We are going to change patients’ lives,” says Scherzer.

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Alternative routes into clinical research: a guide for early career doctors

• Related content
• Peer review
• Phillip LR Nicolson , consultant haematologist and associate professor of cardiovascular science 1 2 3 ,
• Martha Belete , registrar in anaesthetics 4 5 ,
• Rebecca Hawes , clinical fellow in anaesthetics 5 6 ,
• Nicole Fowler , haematology clinical research fellow 7 ,
• Cheng Hock Toh , professor of haematology and consultant haematologist 8 9
• 1 Institute of Cardiovascular Sciences, University of Birmingham, UK
• 2 Department of Haemostasis, Liaison Haematology and Transfusion, University Hospitals Birmingham NHS Foundation Trust, Birmingham
• 3 HaemSTAR, UK
• 4 Department of Anaesthesia, Plymouth Hospitals NHS Trust, Plymouth, UK
• 5 Research and Audit Federation of Trainees, UK
• 6 Department of Anaesthesia, The Rotherham NHS Foundation Trust, Rotherham Hospital, Rotherham
• 7 Department of Haematology, Royal Cornwall Hospitals NHS Trust, Treliske, Truro
• 8 Liverpool University Hospitals NHS Foundation Trust, Prescott Street, Liverpool
• 9 Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool
• Correspondence to P Nicolson, C H Toh p.nicolson{at}bham.ac.uk ; c.h.toh{at}liverpool.ac.uk

Working in clinical research alongside clinical practice can make for a rewarding and worthwhile career. 1 2 3 Building research into a clinical career starts with research training for early and mid-career doctors. Traditional research training typically involves a dedicated period within an integrated clinical academic training programme or as part of an externally funded MD or PhD degree. Informal training opportunities, such as journal clubs and principal investigator (PI)-mentorship are available ( box 1 ), but in recent years several other initiatives have launched in the UK, meaning there are more ways to obtain research experience and embark on a career in clinical research.

Examples of in-person and online research training opportunities

These are available either informally or formally, free of charge or paid, and via local employing hospital trusts, allied health organisations, royal colleges, or universities

Acute medicine

No national trainee research network

Anaesthesia

Research and Audit Federation of Trainees (RAFT). www.raftrainees.org

Cardiothoracic surgery

No national trainee-specific research network. National research network does exist: Cardiothoracic Interdisciplinary Research Network (CIRN). www.scts.org/professionals/research/cirn.aspx

Emergency medicine

Trainee Emergency Medicine Research Network (TERN). www.ternresearch.co.uk

Ear, nose, and throat

UK ENT Trainee Research Network (INTEGRATE). www.entintegrate.co.uk

Gastroenterology

No national trainee research network. Many regional trainee research networks

General practice

No national trainee-specific research network, although national research networks exist: Society for Academic Primary Care (SAPC) and Primary Care Academic Collaborative (PACT). www.sapc.ac.uk ; www.gppact.org

General surgery

Student Audit and Research in Surgery (STARSurg). www.starsurg.org . Many regional trainee research networks

Geriatric Medicine Research Collaborative (GeMRC). www.gemresearchuk.com

Haematology (non-malignant)

Haematology Specialty Training Audit and Research (HaemSTAR). www.haemstar.org

Haematology (malignant)

Trainee Collaborative for Research and Audit in Hepatology UK (ToRcH-UK). www.twitter.com/uk_torch

Histopathology

Pathsoc Research Trainee Initiative (PARTI). www.pathsoc.org/parti.aspx

Intensive care medicine

Trainee Research in Intensive Care Network (TRIC). www.tricnetwork.co.uk

Internal medicine

No trainee-led research network. www.rcp.ac.uk/trainee-research-collaboratives

Interventional radiology

UK National Interventional Radiology Trainee Research (UNITE) Collaborative. https://www.unitecollaborative.com

Maxillofacial surgery

Maxillofacial Trainee Research Collaborative (MTReC). www.maxfaxtrainee.co.uk/

UK & Ireland Renal Trainee Network (NEPHwork). www.ukkidney.org/audit-research/projects/nephwork

Neurosurgery

British Neurosurgical Trainee Research Collaborative (BNTRC). www.bntrc.org.uk

Obstetrics and gynaecology

UK Audit and Research Collaborative in Obstetrics and Gynaecology (UKAROG). www.ukarcog.org

The National Oncology Trainee Collaborative for Healthcare Research (NOTCH). www.uknotch.com

Breast Cancer Trainee Research Collaborative Group (BCTRCG). https://bctrcguk.wixsite.com/bctrcg

Ophthalmology

The Ophthalmology Clinical Trials Network (OCTN). www.ophthalmologytrials.net

Paediatrics

RCPCH Trainee Research Network. www.rcpch.ac.uk/resources/rcpch-trainee-research-network

Paediatric anaesthesia

Paediatric Anaesthesia Trainee Research Network (PATRN). www.apagbi.org.uk/education-and-training/trainee-information/research-network-patrn

Paediatric haematology

Paediatric Haematology Trainee Research Network (PHTN). No website

Paediatric surgery

Paediatric Surgical Trainees Research Network (PSTRN). www.pstrnuk.org

Pain medicine

Network of Pain Trainees Interested in Research & Audit (PAIN-TRAIN). www.paintrainuk.com

Palliative care

UK Palliative Care Trainee Research Collaborative (UKPRC). www.twitter.com/uk_prc

Plastic surgery

Reconstructive Surgery Trials Network (RSTN). www.reconstructivesurgerytrials.net/trainees/

Pre-hospital medicine

Pre-Hospital Trainee Operated Research Network (PHOTON). www.facebook.com/PHOTONPHEM

Information from Royal College of Psychiatrists. www.rcpsych.ac.uk/members/your-faculties/academic-psychiatry/research

Radiology Academic Network for Trainees (RADIANT). www.radiantuk.com

Respiratory

Integrated Respiratory Research collaborative (INSPIRE). www.inspirerespiratory.co.uk

British Urology Researchers in Surgical Training (BURST). www.bursturology.com

Vascular surgery

Vascular & Endovascular Research Network (VERN). www.vascular-research.net

This article outlines these formal but “non-traditional” routes available to early and mid-career doctors that can successfully increase research involvement and enable research-active careers.

Trainee research networks

Trainee research networks are a recent phenomenon within most medical specialties. They are formalised regional or national groups led by early and mid-career doctors who work together to perform clinical research and create research training opportunities. The first of these groups started in the early 2010s within anaesthetics but now represent nearly every specialty ( box 2 ). 4 Trainee research networks provide research training with the aim of increasing doctors’ future research involvement. 5

A non-exhaustive list of UK national trainee led research networks*

Research training opportunities.

Mentorship by PIs at local hospital

Taking on formal role as sub-investigator

Journal clubs

Trainee representation on regional/national NIHR specialty group

API Scheme: https://www.nihr.ac.uk/health-and-care-professionals/training/associate-principal-investigator-scheme.htm .

eLearning courses available at https://learn.nihr.ac.uk (free): Good clinical practice, fundamentals of clinical research delivery, informed consent, leadership, future of health, central portfolio management system.

eLearning courses available from the Royal College of Physicians. Research in Practice programme (free). www.rcplondon.ac.uk

eLearning courses available from the Medical Research Council (free). https://bygsystems.net/mrcrsc-lms/

eLearning courses available from Nature (both free and for variable cost via employing institution): many and varied including research integrity and publication ethics, persuasive grant writing, publishing a research paper. https://masterclasses.nature.com

University courses. Examples include novel clinical trial design in translational medicine from the University of Cambridge ( https://advanceonline.cam.ac.uk/courses/ ) or introduction to randomised controlled trials in healthcare from the University of Birmingham ( https://www.birmingham.ac.uk/university/colleges/mds/cpd/ )

*limited to those with formal websites and/or active twitter accounts. Correct as of 5 January 2024. For regional trainee-led specialty research networks, see www.rcp.ac.uk/trainee-research-collaboratives for medical specialties, www.asit.org/resources/trainee-research-collaboratives/national-trainee-research-collaboratives/res1137 for surgical specialties, and www.rcoa.ac.uk/research/research-bodies/trainee-research-networks for anaesthetics.

Networks vary widely in structure and function. Most have senior mentorship to guide personal development and career trajectory. Projects are usually highly collaborative and include doctors and allied healthcare professionals working together.

Observational studies and large scale audits are common projects as their feasibility makes them deliverable rapidly with minimal funding. Some networks do, however, carry out interventional research. The benefits of increasing interventional research studies are self-evident, but observational projects are also important as they provide data useful for hypothesis generation and defining clinical equipoise and incidence/event rates, all of which are necessary steps in the development of randomised controlled studies.

These networks offer a supportive learning environment and research experience, and can match experience with expectations and responsibilities. Early and mid-career doctors are given opportunities to be involved and receive training in research at every phase from inception to publication. This develops experience in research methodology such as statistics, scientific writing, and peer review. As well as research skills training, an important reward for involvement in a study is manuscript authorship. Many groups give “citable collaborator” status to all project contributors, whatever their input. 6 7 This recognises the essential role everyone plays in the delivery of whole projects, counts towards publication metrics, and is important for future job applications.

Case study—Pip Nicolson (HaemSTAR)

Haematology Specialist Training, Audit and Research (HaemSTAR) is a trainee research network founded because of a lack of principal investigator training and clinical trial activity in non-malignant haematology. It has led and supported national audits and research projects in various subspecialty areas such as immune thrombocytopenia, thrombotic thrombocytopenic purpura, venous thrombosis, and transfusion. 8 9 10 Through involvement in this network as a registrar, I have acted as a sub-investigator and supported the principal investigator on observational and interventional portfolio-adopted studies by the National Institute for Health and Care Research. These experiences gave me valuable insight into the national and local processes involved in research delivery. I was introduced to national leaders in non-malignant haematology who not only provided mentorship and advice on career development, but also gave me opportunities to lead national audits and become involved in HaemSTAR’s committee. 10 11 These experiences in leadership have increased my confidence in management situations as I have transitioned to being a consultant, and have given me skills in balancing clinical and academic roles. Importantly, I have also developed long term friendships with peers across the country as a result of my involvement in HaemSTAR.

Associate Principal Investigator scheme

The Associate Principal Investigator (API) scheme is a training programme run by NIHR to develop research skills and contribute to clinical study delivery at a local level. It is available throughout England, Scotland, Wales, and Northern Ireland for NIHR portfolio-adopted studies. The programme runs for six months and, upon completion, APIs receive formal recognition endorsed by the NIHR and a large number of royal colleges. The scheme is free and open to medical and allied healthcare professionals at all career grades. It is designed to allow those who would not normally take part in clinical research to do so under the mentorship of a local PI. Currently there are more than 1500 accredited APIs and over 600 affiliated studies across 28 specialties. 12 It is a good way to show evidence of training and involvement in research and get more involved in research conduct. APIs have been shown to increase patient recruitment and most people completing the scheme continue to be involved in research. 12 13

Case study—Rebecca Hawes

I completed the API scheme as a senior house officer in 2021. A local PI introduced me to the Quality of Recovery after Obstetric Anaesthesia NIHR portfolio study, 14 which I saw as a training opportunity and useful experience ahead of specialist training applications. It was easy to apply for and straightforward to navigate. I was guided through the six month process in a step-by-step manner and completed eLearning modules and video based training on fundamental aspects of running research projects. All this training was evidenced on the online API platform and I had monthly supervision meetings with the PI and wider research team. As well as the experience of patient recruitment and data collection, other important aspects of training were study set-up and sponsor communications. Key to my successful API scheme was having a supportive and enthusiastic PI and developing good organisational skills. I really enjoyed the experience, and I have since done more research and have become a committee member on a national trainee research network in anaesthesia called RAFT (Research and Audit Federation of Trainees). I’ve seen great enthusiasm among anaesthetists to take part in the API scheme, with over 150 signing up to the most recent RAFT national research project.

Clinical research posts

Dedicated clinical research posts (sometimes termed “clinical research fellow” posts) allow clinicians to explore and develop research skills without committing to a formal academic pathway. They can be undertaken at any stage during a medical career but are generally performed between training posts, or during them by receiving permission from local training committees to temporarily go “out of programme.” These positions are extremely varied in how they are advertised, funded, and the balance between research and clinical time. Look out for opportunities with royal colleges, local and national research networks, and on the NHS Jobs website. Research fellowships are a good way to broaden skills that will have long term impact across one’s clinical career.

Case study—Nicole Fowler

After completing the Foundation Programme, I took up a 12 month clinical trials fellow position. This gave me early career exposure to clinical research and allowed me to act as a sub-investigator in a range of clinical trials. I received practical experience in all stages of clinical research while retaining a patient facing role, which included obtaining consent and reviewing patients at all subsequent visits until study completion. Many of the skills I developed in this post, such as good organisation and effective teamwork, are transferable to all areas of medicine. I have thoroughly enjoyed the experience and it is something I hope to talk about at interview as it is an effective way of showing commitment to a specialty. Furthermore, having a dedicated research doctor has been beneficial to my department in increasing patient involvement in research.

Acknowledgments

We would like to thank Holly Speight and Clare Shaw from the NIHR for information on the API scheme.

*These authors contributed equally to this work

Patient and public involvement: No patients were directly involved in the creation of this article.

PLRN, MB, and CHT conceived the article and are guarantors. All authors wrote and edited the manuscript.

Competing interests: PLRN was the chair of HaemSTAR from 2017 to 2023. MB is the current chair of the Research and Audit Federation of Trainees (RAFT). RH is the current secretary of RAFT. CHT conceived HaemSTAR.

Provenance and peer review: Commissioned; externally peer reviewed.

• Downing A ,
• Morris EJ ,
• Corrigan N ,
• Bracewell M ,
• Medical Academic Staff Committee of the British Medical Association
• ↵ RAFT. The start of RAFT. https://www.raftrainees.org/about
• Jamjoom AAB ,
• Hutchinson PJ ,
• Bradbury CA ,
• McCulloch R ,
• Nicolson PLR ,
• HaemSTAR Collaborators
• Collaborators H ,
• ↵ National Institute for Health and Care Research. Associate Principal Investigator (PI) Scheme. 2023. https://www.nihr.ac.uk/health-and-care-professionals/career-development/associate-principal-investigator-scheme.htm
• Fairhurst C ,
• Torgerson D
• O’Carroll JE ,
• Warwick E ,
• ObsQoR Collaborators

What Is Long COVID? Understanding the Pandemic’s Mysterious Fallout

BY BROOKS LEITNER April 15, 2024

Just weeks after the first cases of COVID-19 hit U.S. shores, an op-ed appeared in The New York Times titled “We Need to Talk About What Coronavirus Recoveries Look Like: They're a lot more complicated than most people realize.” The author, Fiona Lowenstein, is a writer and yoga teacher living in New York City, who wrote about her own illness and the symptoms she was left with once she was released from the hospital. “In the weeks since I was hospitalized for the coronavirus , the same question has flooded my email inbox, texts and direct messages: Are you better yet? I don’t yet know how to answer.”

She was better, she wrote on April 13, 2020 , but she wasn’t well. And others she was in touch with were having the same issue. Unlike most diseases, Long COVID was first described not by doctors, but by the patients themselves. Even the term “Long COVID” was coined by a patient. Dr. Elisa Perego, an honorary research fellow at University College in London, came up with the hashtag #LongCOVID when tweeting about her own experience with the post-COVID syndrome. The term went viral and suddenly social media, and then the media itself, was full of these stories.

Complaints like "I can't seem to concentrate anymore" or "I'm constantly fatigued throughout the day" became increasingly common, seemingly appearing out of nowhere. With nothing abnormal turning up from their many thorough lab tests, patients and their physicians were left feeling helpless and frustrated.

The World Health Organization (WHO) has defined Long COVID as the "continuation or development of new symptoms three months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least two months with no other explanation." This deliberately broad definition reflects the complex nature of this syndrome. We now understand that these symptoms are wide-ranging, including heart palpitations, cough, nausea, fatigue, cognitive impairment (commonly referred to as "brain fog"), and more. Also, many who experience Long COVID following an acute infection face an elevated risk of such medical complications as blood clots and (type 2) diabetes.

As of March 2024 , it’s estimated that about 17% of patients who get COVID-19 will go on to develop post-acute COVID-19 syndrome, the medical term for Long COVID. Data from the Centers for Disease Control and Prevention (CDC) suggest that Long COVID disproportionately affects women, and individuals between the ages of 40 and 49 have the highest reported rates of developing this post-acute infection syndrome.

Long COVID represents a new clinical challenge

Ebony Dix, MD , a Yale School of Medicine (YSM) assistant professor of psychiatry and the medical director of the geriatric psychiatry inpatient unit at Yale New Haven Hospital, said: "Unfortunately, it is not easy to say who is going to get Long COVID and who isn't." She also emphasized that "it can be overlooked and attributed to a preexisting condition. Sometimes the only thing that patients have in their history is a positive COVID test."

Dr. Dix recalled a patient she treated in the COVID psychiatry unit whose unanticipated clinical decline began with increasing fatigue during physical therapy sessions, ultimately necessitating more care over several weeks. Dr. Dix noted, "Long COVID requires time for things to settle down. It might take several months to get back to baseline." Making timely changes to a patient’s treatment plans was essential to helping her patients get back to good health, she said.

A major challenge with Long COVID is how difficult it can be to diagnose. Determining whether new-onset symptoms, such as fatigue or weakness, are related to an underlying condition or entirely attributed to a prior COVID infection is the greatest challenge for those who care for these patients. This is, in large part, due to the lack of research surrounding the topic.

Defining a basis for Long COVID with clinical research

Inderjit Singh, MBChB , a YSM assistant professor specializing in pulmonary, critical care, and sleep medicine, and director of the Pulmonary Vascular Program, is actively engaged in clinical trials aimed at uncovering the fundamental underpinnings of Long COVID. In one research study, patients suffering from unexplained fatigue and shortness of breath undergo exhaustive exercise testing. In order to be enrolled in this study, patients need to have already completed a substantial work-up, including an echocardiogram, pulmonary function testing, chest CT scans, and more, all which result in no alternative diagnosis.

Through this work, a significant revelation emerged. They observed that patients grappling with Long COVID and facing exercise difficulties were unable to efficiently extract oxygen from their bloodstream during physical exertion. This discovery identifies a specific cause underlying the biological underpinnings of Long COVID.

Recognizing the impracticality of conducting comprehensive exercise tests for every Long COVID patient, Dr. Singh, along with other researchers, is focused on the identification of blood-based markers to assess the severity of Long COVID. For example, a research group, led by Akiko Iwasaki, PhD , Sterling Professor of Immunobiology and Molecular, Cellular, and Developmental Biology, and director of the Center for Infection & Immunity at YSM, most recently created a new method to classify Long COVID severity with circulating immune markers.

Further investigations conducted by Dr. Singh's team identified distinctive protein signatures in the blood of Long COVID patients, which correlated with the degree of Long COVID severity. Researchers identified two major and distinct blood profiles among the patients. Some of them exhibited blood profiles indicating that excessive inflammation played a prominent role in their condition, while others displayed profiles indicative of impaired metabolism. Dr. Singh raises a pressing question: "Do we prioritize treating the inflammation or addressing the metabolic defects?"

Although his research findings and those of his peers are progressively unraveling the mysteries of Long COVID, he acknowledges that "significant challenges persist in defining this syndrome.”

Why does Long COVID happen?

The symptoms of Long COVID can vary significantly from one patient to another. Some individuals may be so fatigued that they find it difficult to get out of bed each morning. Others experience heart palpitations, lightheadedness, nausea, vomiting, diarrhea, or brain fog. This broad spectrum of symptoms—more than 200 documented—has led to various hypotheses about the underlying mechanisms at play.

Researchers currently believe that the impairment of a spectrum of key bodily functions may contribute to these diverse symptoms. These potential mechanisms include compromised immune system function, damage to blood vessels, and direct harm to the brain and nervous system. Importantly, it's likely that most patients experience symptoms arising from multiple underlying causes, which complicates both the diagnosis and treatment of Long COVID.

How can Long COVID be treated?

While the diagnosis and treatment of Long COVID remain challenging, the landscape of treatment options is evolving. At Yale’s Multidisciplinary Long COVID Care Center, a team, including respiratory therapists, physical therapists, and clinical social workers, along with an internist, work together to provide a comprehensive evaluation of each patient. Treatment approaches can vary widely and may encompass medications, supplements, physical therapy, or other interventions. Each regimen is designed to meet the specific presentation of Long COVID in each patient.

Dr. Singh’s apt summarization of the situation? "I don't think there's a magic bullet for it." Effective management of Long COVID necessitates a multidisciplinary approach that harnesses the expertise of a wide variety of specialists, working together to provide tailored care and support for these patients.

Brooks Leitner is an MD/PhD candidate at Yale School of Medicine.

The last word from Lisa Sanders, MD:

I’m the internist who sees patients at Yale New Haven Health’s Multidisciplinary Long COVID Care Center. In our clinic, patients are examined by a variety of specialists to determine the best next steps for these complex patients. Sometimes that entails more testing. Often patients have had extensive testing even before they arrive, and far too often—when all the tests are normal—both doctors and patients worry that their symptoms are “all in their head.”

One of our first tasks is to reassure patients that many parts of Long COVID don’t show up on tests. We don’t know enough about the cause of many of these symptoms to create a test for them. The problem is not with the patient with the symptoms, but of the science surrounding them.

If any good can be said to come out of this pandemic, it will be a better understanding of Long COVID and many of the other post-acute infection syndromes that have existed as long as the infections themselves.

If you’d like to share your experience with Long COVID for possible use in a future post (under a pseudonym), write to us at: LongCovid [email protected]

Information provided in Yale Medicine content is for general informational purposes only. It should never be used as a substitute for medical advice from your doctor or other qualified clinician. Always seek the individual advice of your health care provider for any questions you have regarding a medical condition.

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April 16, 2024

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African-led clinical research essential to tackling the continent's health care challenges, says expert

by SciDev.Net

Africa is experiencing unprecedented growth in terms of both population and economic transformation.

As witnessed during the pandemic, there is an increasing critical mass of expertise and ability for health innovation contributing to the global health agenda.

These factors, and the rising burden of both neglected tropical diseases and noncommunicable diseases, present an opportunity to strengthen and expand clinical research and trials throughout Africa.

"Pharma must prioritize uninterrupted health care access by investing in sustainable local capacity, collaboration, and alignment with Africa's public health needs," said Caxton Murira, of the Science for Africa Foundation.

According to Clinicaltrials.gov , Africa accounts for around 4% of global clinical studies. Although reports are sometimes classified as "African" in scope, randomized clinical trials are rarely continent-wide, and many nations are not represented in even one study.

Drug discovery is also inconsistently matched with public health needs, which limits African-led health innovation.

If vaccines, drugs, and medical devices are to work better, they need to be tested on groups of people who have the same epidemiological and demographic traits as the people who will be receiving the treatment.

In recent years, Africa has increased its efforts to be conducive for vaccine development. However, more work is needed to increase Africa's part of vaccine development from its present worldwide proportion of 0.1%.

The inequity can be attributed to several interrelated challenges. They include unpredictable regulatory environments, duplication of efforts because of poor stakeholder coordination, and ecosystem challenges like limited infrastructure, unharmonized regulations, poor market access, a limited policy landscape, insufficient funding.

The Pan African Clinical Trials Registry and the Clinical Trials Community have extensively documented these characteristics.

Why capacity development is critical

Africa-led health research and sustained capacity building in clinical research and trials are essential to tackling Africa's specific health care challenges.

Building a critical mass of expertise through training, infrastructure development, access to technological, and long-term funding, are key components for increasing participation in clinical research and trials. This contributes significantly to the discovery and development of effective and customized vaccines, diagnostics, and therapeutics.

Existing strengths and capacities should be leveraged through equitable partnerships to ensure adequate resource allocation and utilization for positive impact.

COVID-19 underscored the need for a continent-wide, multisectoral, multi-stakeholder approach to achieve desired results. This served as a long-term example of how to cooperate during emergencies. Many lives were saved through initiatives that utilized industry cooperation as part of a coordinated response.

Among Africa's multisectoral initiatives is the Partnerships for African Vaccine Manufacturing (PAVM) initiative, which collaborates with pharmaceutical companies to advance vaccine development and manufacturing through technology transfer, intellectual property support, trade, and policy advocacy.

There is also The H3D Foundation, which partnered with the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) to advance drug research and development in Africa, as well as the African Pharmaceutical Technology Foundation, which strengthens bilateral initiatives to manufacture pharmaceuticals locally, including a partnership between BioNTech and Senegal's Pasteur Institute to produce COVID-19 vaccines.

The role of pharmaceuticals

The pharmaceutical industry has learned that considerable progress requires increasing collaboration and the establishment of well-defined priorities in Africa and other underrepresented regions.

The pharmaceutical business models revolve around the creation of profitable new drugs to prevent and treat existing and emerging diseases to boost company value. This may not always align with patients' desire to receive uninterrupted and affordable access to health care.

Africa as a continent remains an important market for medicines and medical equipment from major pharmaceutical companies and device manufacturers in the higher income countries. Businesses are starting to facilitate the transfer of funds, knowledge, and technology to establish long-term local capability.

Africa's pharmaceutical sector has more than tripled, from US$19 billion in 2012 to $66 billion by 2022, making it the world's fastest-growing market, according to a UN report . With projected growth in the industry, there is the opportunity to create millions of employment and improve the lives of African residents and their families.

Institutions such as the Africa Centers for Disease Control and the African Medicines Agency have been mandated to coordinate with industry players to create an equitable framework to drive the delivery of new products for the African patient. This will require strong commitment from key stakeholders, regulatory oversight, and stakeholder cooperation. It will also require a strong coordination framework.

The Science for Africa Foundation recently announced a new project through its Clinical Research and Trials Community program. The initiative will promote collaboration for clinical research capacity in Africa. It also encourages active industry participation through initiatives such as the Clinical Trials Community Africa Network to enable visibility of clinical trial capacity in Africa and access to clinical trial networks and epidemiological data.

The growth of the pharmaceutical industry in Africa has shown pharma's ability to drive innovation and global health through collaboration. Pharma must prioritize uninterrupted health care access by investing in sustainable local capacity, collaboration, and alignment with Africa's public health needs.

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