Quality Defects and Methods of Reproducibility in Biomedical Research

Andrew Balas MD, PhD

Andrew Balas MD, PhD is a Professor of Public Health at Augusta University, Vice President of the Friends of the NIH National Library of Medicine, member of the American College of Medical Informatics and elected member of the European Academy of Sciences and Arts. His studies about delay and waste in the transfer of research results to health care are frequent reference points in translational research initiatives. The results have been cited by many researchers, policy-makers, and the President of the United States. Currently, he leads the Biomedical Research Innovation Laboratory, a team of researchers conducting ‘science of science’ studies.

Peter L. Elkin MD, MACP, FACMI, FNYAM

Dr. Elkin serves as Professor and Chair of the UB Department of Biomedical Informatics. He is also a Professor of Medicine at the University at Buffalo. Dr. Peter L. Elkin has served as a tenured Professor of Medicine at the Mount Sinai School of Medicine. In this capacity he was the Center Director of Biomedical Informatics, Vice-Chairman of the Department of Internal Medicine and the Vice-President of Mount Sinai hospital for Biomedical and Translational Informatics. Dr. Elkin has published over 120 peer reviewed publications. He received his Bachelors of Science from Union College and his M.D. from New York Medical College. He did his Internal Medicine residency at the Lahey Clinic and his NIH/NLM sponsored fellowship in Medical Informatics at Harvard Medical School and the Massachusetts General Hospital. Dr. Elkin has been working in Biomedical Informatics since 1981 and has been actively researching health data representation since 1987. He is the primary author of the American National Standards Institute’s (ANSI) national standard on Quality Indicators for Controlled Health Vocabularies ASTM E2087, which has also been approved by ISO TC 215 as a Technical Specification (TS17117). He has chaired Health and Human Service’s HITSP Technical Committee on Population Health. Dr. Elkin served as the co-chair of the AHIC Transition Planning Group. Dr. Elkin is a Master of the American College of Physicians and a Fellow of the American College of Medical Informatics. Dr. Elkin chairs the International Medical Informatics Associations Working Group on Human Factors Engineering for Health Informatics. Dr. Elkin is the Editor of the Springer Informatics Textbook, Terminology and Terminological Systems. He was awarded the Mayo Department of Medicine’s Laureate Award for 2005. Dr. Elkin is the index recipient of the Homer R. Warner award for outstanding contribution to the field of Medical Informatics.

Anna Fine PharmD, MS

Anna M. Fine, PharmD, MS, is Acting Director of ClinicalTrials.gov, an international registry and results database of clinical research, at the National Center for Biotechnology Information, National Library of Medicine, NIH. As Acting Director, she is responsible for technical, scientific, policy, regulatory, and outreach activities related to the operation of ClinicalTrials.gov. Dr. Fine assumed this role in 2021, after having served as deputy director since 2018.

Steven Goodman MD, PhD

Steven Goodman, MD, PhD is Associate Dean of Clinical and Translational Research and Professor of Epidemiology and Population Health, and Medicine. He is co-founder and co-director of the Meta-research innovation Center at Stanford (METRICS), a group dedicated to examining and improving the reproducibility and efficiency of biomedical research. He has since created and leads another initiative, the Stanford Program on Research Rigor and Reproducibility (SPORR), whose purpose is to teach and implement best practices in reproducible research in the School of Medicine. He led the Stanford CTSA KL2 and TL1 training programs from 2012-2019, and now leads the Translational Workforce Development components of the CTSA.

Dr. Goodman’s own research concerns the proper measurement, conceptualization and synthesis of research evidence, with particular emphasis on Bayesian approaches to quantitation, and qualitative approaches arising from the philosophy of science. He is also interested in developing methods to use shared data to confirm and extend published science. He also has worked on the connections between ethics and clinical research and policy making. Finally, he has a strong interest in developing curricula and new models for teaching the foundations of good scientific practice, from question development to proper study design, conduct, analysis and inference. He teaches courses on clinical research methods, foundations of scientific and statistical reasoning, and evaluation of diagnostic and predictive technologies.

He has been a senior statistical editor of Annals of Internal Medicine since 1987 and was Editor of Clinical Trials: Journal of the Society for Clinical Trials from 2004-2013. He is Chair of the Methodology Committee of the Patient Centered Outcomes Research Institute (PCORI), where he led their open science and data sharing efforts, and is scientific advisor for the national Blue Cross–Blue Shield Technology Assessment Program. He has served on numerous Institute of Medicine committees since the mid 1990’s, including one on vaccine safety, chairing a 2012 committee on drug safety, and a 2014 committee on sharing data from clinical trials. He was awarded the 2016 Spinoza Chair in Medicine from the University of Amsterdam for his work in scientific inference, received the 2019 Abraham Lilienfeld award from the American College of Epidemiology for his lifetime research and teaching contributions to the field, and was elected into the National Academy of Medicine in 2020.

From 1989-2011, Steve served on the faculties of the Johns Hopkins Schools of Medicine and Public Health, where he was co-director of the doctoral program in Epidemiology and member (1989-2011) and then director (2007-2011) of the Johns Hopkins cancer center’s Division of Biostatistics and Bioinformatics. At Hopkins, he taught courses on Systematic reviews and Meta-analysis, Diagnostic and prognostic testing, and several courses on epidemiologic, clinical research and inferential methods. He received an AB from Harvard, majoring in Biochemistry and Applied Math, an MD from NYU, trained and was board-certified in pediatrics at Washington University in St. Louis, and received a master’s degree in Biostatistics and PhD in Epidemiology from Johns Hopkins.

Sarah Jenkins

Sarah Jenkins is the Senior Director for Research Integrity & Publishing Ethics for Elsevier. Sarah and her team promote research integrity and publishing ethics through policies, best practices, and education, support Elsevier’s Publishing Teams and Editors to investigate and resolve concerns about the integrity of published papers, and work with specialists across Elsevier to build tools and develop processes that detect unethical practices during the manuscript submission and peer-review process.

Sarah began her publishing career at Elsevier working with Editors and learned societies in health and medical sciences. Sarah later joined the Physical Science group as a Publishing Director where she focused on open access and open science through initiatives that promoted the deposition of code and software, and established links between original research articles and data journals.

Michael Lauer MD

Michael Lauer, M.D., is the Deputy Director for Extramural Research at the National Institutes of Health (NIH), where he serves as the principal scientific leader and advisor to the Director of the NIH on all matters relating to the substance, quality, and effectiveness of the NIH extramural research program and administration. He received education and training at Rensselaer Polytechnic Institute, Albany Medical College, Harvard Medical School, Harvard School of Public Health, and the NHLBI’s Framingham Heart Study. He spent 14 years at Cleveland Clinic as Professor of Medicine, Epidemiology, and Biostatistics. During his tenure at the Clinic, he led a federally funded internationally renowned clinical epidemiology program that applied big data from large-scale electronic health platforms to questions regarding the diagnosis and management of cardiovascular disease. From 2007 to 2015 he served as a Division Director at the National Heart, Lung, and Blood Institute (NHLBI), where promoted efforts to leverage big data infrastructure to enable high-efficiency population and clinical research and efforts to adopt a research funding culture that reflected data-driven policy. He has received numerous awards including the NIH Equal Employment Opportunity Award of the Year and the Arthur S. Flemming Award for Exceptional Federal Service in recognition of his efforts to grow a culture of learning and accountability.

Ivan Oransky MD

Ivan Oransky, MD, is co-founder of Retraction Watch, editor in chief of The Transmitter, and distinguished journalist in residence at New York University’s Arthur Carter Journalism Institute. Ivan previously was president of the Association of Health Care Journalists and vice president of editorial at Medscape. He has also held editorial leadership positions at MedPage Today, Reuters Health, Scientific American and The Scientist. He is the recipient of the 2015 John P. McGovern Medal for excellence in biomedical communication from the American Medical Writers Association, and in 2017 was awarded an honorary doctorate in civil laws from The University of the South (Sewanee). In 2019, the judges for the John Maddox Prize, which promotes those who stand up for science in the face of hostility, gave him a commendation for his work at Retraction Watch.

Nathalie Percie du Sert PhD

Head of Experimental Design and Reporting, UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs)

Nathalie Percie du Sert (she/her) leads the NC3Rs’ work to improve the reliability of preclinical and basic research, both in terms of the work funded by the centre, and work funded elsewhere. The NC3Rs provides training for researchers and stakeholders at all stages of the research process, and an extensive library of freely available, online resources. This includes the Experimental Design Assistant, an online expert system to guide researchers through the design of in vivo experiments and the ARRIVE guidelines to improve the design and reporting of animal research in scientific publications.

Nathalie holds a PhD from St George’s University of London. Prior to joining the NC3Rs, she worked as a post-doctoral researcher in the field of nausea and emesis at the University of California, San Francisco and at the Chinese University of Hong Kong, where she developed expertise in in vivo research and systematic reviews and meta-analysis of animal models.

Chris Winchester

Chris Winchester is CEO of Oxford PharmaGenesis, an award-winning HealthScience communications consultancy with over 500 employees in Europe, North America and Asia Pacific. Chris studied Biochemistry at St Catherine’s College, Oxford, leaving with a doctorate in 1997. He has co-authored observational studies, systematic reviews and Delphi consensus development processes, including studies on the role of pharmaceutical companies and communications consultancies in transparency and reporting. Chris is a Co-founder of Open Pharma, a Director of Oxford Health Policy Forum, an Associate Fellow of Green Templeton College, Oxford, a Director of the Friends of the National Library of Medicine and a past Chair of the International Society for Medical Publication Professionals.