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Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk (2015)

Chapter: Appendix E: Biosketches of Committee Members

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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Appendix E

Biosketches of Committee Members

Bernard Lo, M.D. (Chair), is currently president of the Greenwall Foundation. Previously, Dr. Lo was professor of medicine and director of the Program in Medical Ethics at the University of California, San Francisco (UCSF). Currently he is co-chair of the Standards Working Group of the California Institute of Regenerative Medicine, which recommends regulations for stem cell research funded by the state of California. Dr. Lo serves on the Board of Directors of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) and on the Medical Advisory Panel of Blue Cross/Blue Shield. Formerly he was a member of the National Bioethics Advisory Commission under President Clinton, the U.S. National Institutes of Health (NIH) Recombinant DNA Advisory Committee and the Ethics Subcommittee, and the Advisory Committee to the Director of the Centers for Disease Control and Prevention. He served on a number of Data and Safety Monitoring Committees at NIH for HIV prevention and treatment, diabetes prevention, and oxygen treatment in chronic obstructive pulmonary disease. A member of the Institute of Medicine (IOM), Dr. Lo served on the IOM Council and chaired the Board on Health Sciences Policy. He chaired IOM committees on conflicts of interest in medicine and on confidentiality in health services research and has been a member of several other IOM committees. He currently is a member of the Board of Life Sciences of the National Academy of Sciences (NAS).

Dr. Lo and his colleagues have published approximately 200 peer-reviewed articles on ethical issues concerning decision making near the

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

end of life, stem cell research, research with human participants and its oversight, the doctor–patient relationship, conflicts of interest, HIV infection, and public health. With colleagues on the UCSF stem cell research oversight committee, he has written articles on ethical issues in the procurement of embryos for research, oversight of stem cell lines derived in other institutions, informed consent for future research, and prohibiting the use of induced pluripotent stem cells for reproductive cloning. Dr. Lo is the author of Resolving Ethical Dilemmas: A Guide for Clinicians (5th ed., 2013) and of Ethical Issues in Clinical Research (2010). At UCSF he directed medical student teaching in ethics, chaired the hospital ethics committee, and served as an attending physician on the medicine inpatient service. He was co-director of the Policy and Ethics Core of the Center for AIDS Prevention Studies. He continues to serve as the primary care physician for a panel of general internal medicine patients.

Timothy Coetzee, Ph.D., is chief advocacy, services and research officer of the National Multiple Sclerosis Society. In this capacity he leads mission delivery in the areas of state and federal advocacy and service and care management programs for people with multiple sclerosis, as well as the Society’s research program, which funds more than 375 academic and commercial research projects around the world. Most recently, he served as president of Fast Forward, a venture philanthropy of the National Multiple Sclerosis Society, where he was responsible for the Society’s strategic funding of biotechnology and pharmaceutical companies, as well as partnerships with the financial and business communities. Prior to serving with Fast Forward, Dr. Coetzee led the Society’s translational research initiatives on nervous system repair and protection in multiple sclerosis. He is a member of the IOM’s Forum on Neuroscience and Nervous System Disorders and serves on the Board of Directors of the American Society of Experimental Neurotherapeutics. He also chairs the Integration Panel for the Multiple Sclerosis Research Program of the Department of Defense Congressionally Directed Medical Research Program. Dr. Coetzee received his Ph.D. in molecular biology from Albany Medical College in 1993 and has since been involved in the field of multiple sclerosis research. He has been with the National Multiple Sclerosis Society since fall 2000.

David L. DeMets, Ph.D., is currently Max Halperin professor of biostatistics and founder/former chair of the Department of Biostatistics and Medical Informatics at the University of Wisconsin–Madison. Since receiving his Ph.D. in 1970 from the University of Minnesota, he has been very active in the design, conduct, and analysis of clinical trials in several disease areas. Following a postdoctoral appointment at NIH (1970-1972), he spent 10 years (1972-1982) at the NIH National Heart, Lung, and Blood

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

Institute (NHLBI), where he became chief of the Biostatistics Research Branch. He has co-authored four texts on the topic of clinical trial design, interim monitoring, and analyses. Dr. DeMets is a recognized international leader in statistical research and methods for the analysis of clinical trials. He has collaborated in the development of statistical methods for the sequential analysis of outcome data and the design of clinical trials. He has extensive national and international clinical trial experience and has served on and chaired numerous NIH and industry-sponsored data safety and monitoring committees for clinical trials in diverse disciplines. He served on the Board of Scientific Counselors of the National Cancer Institute and Board of Directors of the American Statistical Association, and was president of the Society for Clinical Trials and of the Eastern North American Region (ENAR) of the Biometric Society. He is a fellow of the American Statistical Association, the International Statistics Institute, the Society of Clinical Trials, the American Medical Informatics Association, and the American Association for the Advancement of Science. Dr. DeMets has served on the Human Subjects Committee (1982-1987) and on several University of Wisconsin committees since 1990. He also has served on several of the university’s search committees and graduate school committees.

Jeffrey Drazen, M.D., joined the New England Journal of Medicine (NEJM) as editor-in-chief in July 2000. At NEJM, Dr. Drazen’s responsibilities include oversight of all editorial content and policies. His editorial background includes service as an associate editor or editorial board member for the Journal of Clinical Investigation, the American Journal of Respiratory Cell and Molecular Biology, and the American Journal of Medicine. A specialist in pulmonology, Dr. Drazen maintains an active research program. He has published more than 300 articles on such topics as lung physiology and the mechanisms involved in asthma. In 1999, he delivered the Amberson Lecture, the major research address at the annual meeting of the American Thoracic Society. In 2000, he received the Chadwick Medal from the Massachusetts Thoracic Society for his contributions to the study of lung disease. Dr. Drazen is distinguished Parker B. Francis professor of medicine at Harvard Medical School, professor of physiology at the Harvard School of Public Health, and a senior physician at Brigham and Women’s Hospital. In 2003, he was elected to the IOM. He has served on numerous NIH committees and on the Veterans’ Administration National Research Advisory Committee. He currently serves on the Global Initiative for Asthma Science Committee and the World Health Organization’s Scientific Advisory Group on Clinical Trials Registration and co-chairs the IOM’s Forum on Drug Discovery, Development, and Translation. Dr. Drazen earned his bachelor’s degree and graduated summa cum laude from Tufts Univer-

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

sity. He received his medical degree from Harvard Medical School and completed his internship and residency at Peter Bent Brigham Hospital in Boston. He has received honorary degrees from the University of Ferrara, Italy, and the National and Kapodistrian University of Athens, Greece.

Steven N. Goodman, M.D., M.H.S., Ph.D., is associate dean for clinical and translational research and professor of medicine and health research and policy at Stanford University School of Medicine. He is the editor of Clinical Trials: Journal of the Society for Clinical Trials and is senior statistical editor of the Annals of Internal Medicine, where he has served since 1987. He has served previously on six IOM committees. Dr. Goodman is vice-chair of the Methodology Committee of the Patient-Centered Outcomes Research Institute and scientific advisor to the Medical Advisory Panel of the National Blue Cross/Blue Shield Technology Evaluation Center. He directs Stanford’s Clinical and Translational Science Award (CTSA) research training programs and co-directs a new center focused on improving the validity and reproducibility of published medical research. Before joining Stanford in 2011, Dr. Goodman was professor of oncology in the Division of Biostatistics and Bioinformatics of the Johns Hopkins Kimmel Cancer Center, with appointments in the departments of Pediatrics, Biostatistics, and Epidemiology in the Johns Hopkins Schools of Medicine and Public Health. He was on the core faculties of the Johns Hopkins Center for Clinical Trials, the Berman Bioethics Institute, and the Graduate Training Program in Clinical Investigation and co-directed the epidemiology doctoral program. Dr. Goodman received an A.B. from Harvard and an M.D. from New York University, trained in pediatrics at Washington University, and received an M.H.S. in biostatistics and a Ph.D. in epidemiology from Johns Hopkins University. He writes and teaches on evidence evaluation and inferential, methodologic, and ethical issues in epidemiology and clinical research.

Patricia A. King, J.D., has expertise in the study of law, medicine, ethics, and public policy. She is also an adjunct professor in the Department of Health Policy and Management, School of Hygiene and Public Health, at Johns Hopkins University. She is the co-author of Cases and Materials on Law, Science and Medicine. She teaches family law courses and offers a seminar in bioethics and the law. She is a member of the American Law Institute and the IOM and a fellow of the Hastings Center. She is currently a member of the IOM’s Board on Health Sciences Policy. Ms. King’s work in the field of bioethics has included service on the Department of Health, Education, and Welfare (HEW) Recombinant DNA Advisory Committee; the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research; the National Commission for

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

the Protection of Human Subjects of Biomedical and Behavioral Research; and the Ethics, Legal and Social Issues Working Group of the Human Genome Project. She is a former member of the Harvard Corporation and trustee emeritus of Wheaton College. Her professional experience before joining the Law Center faculty in 1973 was primarily in the civil rights field; she was deputy director of the Office of Civil Rights and special assistant to the chairman of the U.S. Equal Employment Opportunity Commission (EEOC). She also served as a deputy assistant attorney general in the Civil Division of the Department of Justice.

Trudie Lang, Ph.D., is a clinical trials research methodologist with specific expertise in capacity development and trial operations in low-resource settings. She currently leads the Global Health Network (GHN), a forum that seeks to help clinical researchers with trial design and methods, interpretation of regulations, and general operations. GHN conducts methodology research to identify the real barriers and issues involved in noncommercial trials, with the aim of developing best practice guidelines. Dr. Lang has worked in the field of clinical trials for 20 years and has experienced the benefits of working in the pharmaceutical industry, the World Health Organization, and academia. Ten years of managing trials in industry gave her strong capabilities in leading teams, dealing with regulations, managing complex projects, and conducting effective strategic planning and taught her the rigors of designing and operating clinical trials in varied settings. At Oxford she has further developed her expertise in the design, operation, and methodology of running trials in developing countries. Dr. Lang set up a clinical trial facility in Kenya with a strong focus on developing local research skills and engagement. More recently, she devised and set up Global Health Trials (www.globalhealthtrials.org), an online, research-led facility designed to support and guide research teams and used by more than 200,000 researchers. It evolved into The Global Health Network (www.theglobalhealthnetwork.org), a virtual science park that hosts 25 international collaborations across varied disease areas, all aiming to support research by sharing knowledge, research tools, and methods.

Deven McGraw, J.D., M.P.H., L.L.M., is a partner in the health care practice of Manatt, Phelps & Phillips, LLP. She provides legal, regulatory, and strategic policy and business counsel to health care providers, payers, and other health care organizations with respect to the adoption and implementation of health information technology (IT) and electronic health information exchange. Her areas of focus include Health Insurance Portability and Accountability Act (HIPAA)/privacy advice and compliance, data security, data governance, research and health data analytics, health

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

information technology (IT) policy, and patient engagement. Previously, Ms. McGraw was director of the Health Privacy Project at the Center for Democracy & Technology (CDT). In this role, she led efforts to develop and promote workable privacy and security protections for electronic personal health information. Ms. McGraw’s background includes service on a number of committees established by the U.S. Department of Health and Human Services (HHS) and other work groups to provide guidance on a wide array of health IT, privacy and security policy, and business issues. She was one of three people appointed by former HHS Secretary Kathleen Sebelius to serve on the Health Information Technology Policy Committee, a federal advisory committee established under the American Recovery and Reinvestment Act of 2009. Ms. McGraw also served on two key work groups of the American Health Information Community, the federal advisory body established by HHS in the Bush administration to develop recommendations on how to facilitate use of health IT to improve health. She also served on the Policy Steering Committee of the eHealth Initiative and currently serves on its Leadership Committee. She serves as well on the Steering Committee of the Electronic Data Methods Forum and leads the privacy policy work for the Patient-Centered Outcomes Research Network. Prior to her service with CDT, Ms. McGraw was chief operating officer at the National Partnership for Women & Families. Earlier in her career, she was an associate in the public policy and health care groups of two international law firms. She also served as deputy legal counsel to the governor of Massachusetts and taught in the Federal Legislation Clinic at the Georgetown University Law Center.

Elizabeth Nabel, M.D., has served as president of Harvard-affiliated Brigham and Women’s Hospital (BWH) since 2010. A cardiologist and distinguished biomedical researcher, Dr. Nabel is professor of medicine at Harvard Medical School. She brings a unique perspective to health care based on her experience as a physician, research scientist, academic medicine leader, and wellness advocate. At BWH, she led the development of a comprehensive strategic plan that defines a new model of medicine characterized by cross-disciplinary collaboration, patient-inclusive care, and innovation. Initiatives include a new translational medical facility; patient-centered intensive care unit (ICU) care; and a $1 billion campaign to advance innovation, patient care, and community health. Dr. Nabel has a long record of advocacy for health and for broadening access to care. As director of NHLBI from 2005 to 2009, she leveraged a $3 billion research portfolio to establish pioneering scientific programs in genomics, stem cells, and translational research. One of her signature advocacy efforts was the Red Dress Heart Truth campaign, which raises heart awareness in women through innovative partnerships. Throughout her career, Dr.

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

Nabel has been a champion for global health. At NHLBI, she established centers of excellence in developing countries to combat cardiovascular and lung diseases. At BWH she helped create a national teaching hospital in Haiti and is advancing training for clinicians in underresourced countries. An accomplished physician-scientist, Dr. Nabel has conducted work on the molecular genetics of cardiovascular diseases that has produced 17 patents and more than 250 scientific publications. Her colleagues elected her to the American Academy of Arts and Sciences and the IOM, and she is a fellow of the American Association for the Advancement of Science. Her honors include the Willem Einthoven Award from Leiden University in the Netherlands, two Distinguished Achievement Awards from the American Heart Association, and six honorary doctorates. Dr. Nabel attended Weill Cornell Medical College and completed her cardiology training at BWH.

Arti Rai, J.D., is an internationally recognized expert in intellectual property (IP) law, administrative law, and health policy. She has also taught at the Harvard, Yale, and University of Pennsylvania law schools. Her research on IP law and policy in biotechnology, pharmaceuticals, and software has been funded by NIH, the Kauffman Foundation, and the Woodrow Wilson Center. She has published more than 50 articles, essays, and book chapters on IP law, administrative law, and health policy. Her publications have appeared in both peer-reviewed journals and law reviews. She is the editor of Intellectual Property Law and Biotechnology: Critical Concepts (Edward Elgar, 2011), co-author of a 2012 Kauffman Foundation monograph on cost-effective health care innovation, and co-author of a casebook on law and the mental health system. From 2009 to 2010, Ms. Rai served as administrator of the Office of External Affairs at the U.S. Patent and Trademark Office (USPTO). Prior to that, she served on President-Elect Obama’s transition team reviewing the USPTO. Before entering academia, Ms. Rai clerked for the Honorable Marilyn Hall Patel of the U.S. District Court for the Northern District of California, was a litigation associate at Jenner & Block, and was a litigator in the U.S. Department of Justice’s Civil Division. Ms. Rai regularly testifies before Congress and relevant administrative bodies on IP law and policy issues and advises federal agencies on IP policy issues raised by the research they fund. She is a member of the National Advisory Council for Human Genome Research and of an Expert Advisory Council to the Defense Advanced Projects Research Agency. She is a public member of the Administrative Conference of the United States, a member of the American Law Institute, and co-chair of the IP Committee of the Administrative Law Section of the American Bar Association. In 2011, Ms. Rai won the World Technology Network Award for Law. She graduated from Harvard College, magna

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

cum laude, with a B.A. in biochemistry and history; attended Harvard Medical School for the 1987-1988 academic year; and received her J.D., cum laude, from Harvard Law School in 1991.

Ida Sim, M.D., Ph.D., is professor of medicine; co-director of biomedical informatics at UCSF’s Clinical and Translational Science Institute; and co-founder of Open mHealth, a nonprofit organization that is breaking down barriers to mobile health app and data integration through an open software architecture. Her primary research work is on knowledge-based technologies for evidence-based practice, especially in the ontological representation of clinical trials for data sharing and scientific computation. In 2005, Dr. Sim was founding project coordinator of the World Health Organization’s International Clinical Trials Registry Platform. She led the establishment of the first global policy on clinical trial registration, including the development of the Trial Registration Data Set, the common 20-item data set adhered to by all registries worldwide. She has also published on clinical trial reporting bias, new models of scientific epublication of clinical research, and other policies and practices of trial reporting and registration. Dr. Sim was a member of the National Research Council committee that produced a report on computational technology for effective health care. She is a recipient of the United States Presidential Early Career Award for Scientists and Engineers, a fellow of the American College of Medical Informatics, and a member of the American Society for Clinical Investigation. She is also a practicing primary care physician.

Sharon Terry, M.A., is president and CEO of Genetic Alliance, a network of more than 10,000 organizations, 1,200 of which are disease advocacy organizations. Genetic Alliance engages individuals, families, and communities to transform health. Ms. Terry also is founding CEO of PXE International, a research advocacy organization for the genetic condition pseudoxanthoma elasticum (PXE). As co-discoverer of the gene associated with PXE, she holds the patent for ABCC6 to act as its steward and has assigned her rights to the foundation. She developed a diagnostic test for the condition and conducts clinical trials. She is the author of 140 peer-reviewed papers, 30 of which are PXE clinical studies. Ms. Terry also is a co-founder of the Genetic Alliance Registry and Biobank. In the forefront of consumer participation in genetics research, services, and policy, she serves in a leadership role for many of the major international and national organizations in this area. She serves as well on the editorial boards of several journals and is an editor of Genome. She led the coalition that was instrumental in the passage of the Genetic Information Nondiscrimination Act. Ms. Terry received an honorary doctorate from Iona College for her work in community engagement in 2006, the first Patient Service Award

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

from the University of North Carolina at Chapel Hill Institute for Pharmacogenomics and Individualized Therapy in 2007, the Research!America Distinguished Organization Advocacy Award in 2009, and the Clinical Research Forum and Foundation’s Annual Award for Leadership in Public Advocacy in 2011. In 2012, she became an honorary professor of Hebei United University in Tangshan, China, and also received the Facing Our Risk of Cancer Empowered (FORCE) Spirit of Empowerment Advocacy Award. She was named one of the U.S. Food and Drug Administration’s “30 Heroes for the Thirtieth Anniversary of the Orphan Drug Act” in 2013. In 2012 and 2013, Ms. Terry won first prizes in three large competitions for the Platform for Engaging Everyone Responsibly (PEER), which was awarded a $1 million contract from the Patient-Centered Research Outcomes Institute in 2014. She also is an Ashoka fellow.

Joanne Waldstreicher, M.D., is chief medical officer, Johnson & Johnson. In this role, she has oversight for epidemiology and safety of all Johnson & Johnson products worldwide across all sectors, including pharmaceuticals, devices, and consumer products. In addition, she plays a leadership role for internal and external partnerships and collaborations, including the development of corporate science and technology policies. Dr. Waldstreicher also chairs the Pharmaceuticals R&D Development Committee, which reviews all late-stage development programs in the pharmaceutical pipeline. Previously, she was chief medical officer of the pharmaceutical sector and head of Asia Pacific medical sciences. Prior to that, she was head of global drug development for the Johnson & Johnson Pharmaceutical Research & Development, LLC (J&JPRD) Central Nervous System/Internal Medicine business unit. Prior to joining J&JPRD in 2002, Dr. Waldstreicher was head of the endocrinology and metabolism clinical research group at Merck Research Laboratories. During that time, she received numerous distinctions, including the Merck Research Laboratory Key Innovator Award. Dr. Waldstreicher received the Jonas Salk and Belle Zeller scholarships from the City University of New York and graduated summa cum laude from Brooklyn College and cum laude from Harvard Medical School. She completed her fellowship in endocrinology and metabolism at Massachusetts General Hospital, has won numerous awards and scholarships, and has authored numerous papers and abstracts.

IOM ANNIVERSARY FELLOW

Scott D. Halpern, M.D., Ph.D., is assistant professor of medicine, epidemiology, and medical ethics and health policy at the Perelman School of Medicine, University of Pennsylvania. He is founding director of the

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

Fostering Improvement in End-of-Life Decision Science (FIELDS) program, deputy director of the Center for Health Incentives and Behavioral Economics, and a practicing critical care medicine doctor. The FIELDS program, which Dr. Halpern founded in 2012, includes scholars from multiple health-related disciplines who are united by the belief that untoward influences on how patients, family members, and providers make choices contribute to the high intensity of care that many patients receive near the end of their life. Dr. Halpern’s research is supported by NIH, the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, and the American Heart Association. Most of his funding supports randomized trials of behavioral and health system interventions. He has received the United States’ most prestigious awards for young academics in two different disciplines: the Greenwall Foundation Faculty Scholar Award (2008) in bioethics and AcademyHealth’s Alice S. Hersh New Investigator Award (2011) in health services research. In 2012, Dr. Halpern was recognized with a Young Leader Award from the Robert Wood Johnson Foundation as 1 of 10 people aged 40 or under “who offer great promise for leading the way to improved health and health care for all Americans.” He is an anniversary fellow at the IOM and a member of the editorial board of the Annals of Internal Medicine. Dr. Halpern is the author of more than 100 scientific articles and has consulted on ethical and scientific matters for NIH, the Centers for Disease Control and Prevention, the United Network for Organ Sharing, The World Bank, and two advisory committees to the U.S. Secretary of Health and Human Services.

Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Suggested Citation:"Appendix E: Biosketches of Committee Members." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health.

Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs.

Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

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