HSPH-HMS214x: Fundamentals of Clinical Trials


Clinical trials play a pivotal role in evidence-based medicine. This course will discuss the design, conduct, analysis, and interpretation of Phase I-IV clinical studies.

About this Course

*Note - This is an Archived course*

This is a past/archived course. At this time, you can only explore this course in a self-paced fashion. Certain features of this course may not be active, but many people enjoy watching the videos and working with the materials. Make sure to check for reruns of this course.

This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical trials research. Topics include the design, implementation, and analysis of trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, treatments, and endpoints, randomization procedures, sample size determination, data analysis, and study interpretation. The ethical issues that arise at each phase of therapy development will be explored.

This course contains 12 modules. The modules will be released Monday of each week, with the exception of some holiday weeks. Most students should plan to spend 4 – 6 hours on each module. Students will have until February 14, 2014 to earn a HarvardX certificate.

Before your course starts, try the new edX Demo where you can explore the fun, interactive learning environment and virtual labs. Learn more.

Course Staff

  • James Ware

    Professor Ware's research focuses on methods for the analysis of longitudinal data and on the design and analysis of clinical trials. He has served as senior statistician for randomized trials of strategies for protecting the brain during surgical repair of transposition of the great arteries in infants, chelation therapy for lead-exposed children and, currently, vitamin D supplementation to prevent development of diabetes. He has been a statistical consultant to the New England Journal of Medicine since 1990.

    Dr. Ware has taught on clinical trials (BIO214) for many years at the Harvard School of Public Health. He has also been involved in the development of masters degree programs in epidemiology and biostatistics with international partners in Cyprus and Saudi Arabia.

  • Elliott Antman

    Dr. Elliott M. Antman is a senior faculty member in the Cardiovascular Division of the Brigham and Women's Hospital in Boston, Massachusetts. He is Professor of Medicine at Harvard Medical School. At the Brigham and Women’s Hospital, Dr. Antman has been recognized for his active role and interest in education and training. Dr. Antman is a Senior Investigator in the Thrombolysis in Myocardial Infarction (TIMI) Study Group. Dr. Antman has been an active participant in American Heart Association (AHA) and American College of Cardiology (ACC) activities. In 2009, Dr. Antman became Director of the Harvard Catalyst Program for Postgraduate Education in Clinical and Translational Science. The goal of this program is to establish the infrastructure for coordination, integration, and oversight of clinical/translational postgraduate educational and training opportunities throughout the Harvard system.

  • Julie Buring

    Dr. Julie E. Buring is Professor of Medicine at Harvard Medical School and Brigham and Women’s Hospital; and Professor of Epidemiology at the Harvard School of Public Health.

    The primary focus of her research is on the prevention of chronic diseases, especially among women. Dr. Buring has been involved in the design, conduct, analysis, and interpretation of a number of large-scale randomized clinical trials of the primary prevention of cardiovascular disease, cancer and other chronic diseases. These include the Women’s Health Study, evaluating the preventive roles of aspirin and vitamin E; the Physicians' Health Study II, evaluating vitamin E, vitamin C, beta-carotene, and a multivitamin; and VITAL, an ongoing trial of vitamin D and fish oil.

    Dr. Buring is actively involved in the teaching and training of students and fellows in epidemiology, both nationally and internationally, and is co-Director of an NIH T32 training grant in the Epidemiology of Cardiovascular Disease. She serves as Chair of the Institutional Review Board of Harvard Medical School.

  • Graham McMahon

    Graham McMahon M.D. M.M.Sc. is an Associate Professor of Medicine and member of the Academy at Harvard Medical School. He is a faculty member in the division of endocrinology, diabetes and hypertension at Brigham & Women’s Hospital in Boston, where he completed his postgraduate training. Dr. McMahon received his medical education at the Royal College of Surgeons in Ireland, a master’s degree in clinical research from Harvard Medical School, and his doctorate in education from the National University of Ireland. He is the editor for medical education at the New England Journal of Medicine. He directs the endocrinology course at Harvard Medical School and the tutorial program for “Introduction to the Profession.” He has received local and national awards for his teaching and his work in medical education and diabetes research. His work has been published in the New England Journal of Medicine, Diabetes Care, the Archives of Internal Medicine, the Journal of General Internal Medicine, and Medical Education. His research interests include systems of care for diabetes patients, cardiovascular disease in diabetes, and medical education.

  • Marcia Testa

    Marcia Testa (PhD, MPhil, MPH) is a Senior Lecturer on Biostatistics in the Department of Biostatistics at the Harvard School of Public Health. Dr. Testa and colleagues are developing quantitative and health information technology methods and processes relating to the measurement and analysis of expanded patient outcomes (quality of life, cost-effectiveness and risk-benefit) for clinical, pharmacoeconomic, pharmacoepidemiologic, quality of care and comparative effectiveness research studies with particular application to primary care, cardiovascular disease, HIV, and diabetes.

  • Robert Truog

    Robert D. Truog, MD, is Professor of Medical Ethics, Anaesthesia and Pediatrics at Harvard Medical School. He has practiced pediatric intensive care medicine at Children’s Hospital Boston for more than 25 years, including serving as Chief of the Division for more than a decade. He is Director of Clinical Ethics at Harvard Medical School, where he is responsible for directing the academic and teaching efforts of the Division. As Executive Director of the Institute for Professionalism and Ethical Practice, he creates and teaches highly interactive seminars to enhance the ability of clinicians to engage in difficult conversations with patients and families. He has published more than 200 articles and books in bioethics and related disciplines, including most recently Death, Dying, and Organ Transplantation (2012, Oxford).

  • Emile Yu

    Emile Yu is a M.S. candidate studying Biostatistics at the Harvard School of Public Health. She has a B.A. & B.Sc. in Economics and Biomedical Sciences from McGill University in Montreal, Canada. She is currently working at the Dana-Farber Cancer Institute doing research on the effect of gemcitabine singlet chemotherapy versus doublet chemotherapy on overall survival and progression-free survival in metastatic pancreatic cancer patients.

  • Nakul Singh

    Nakul Singh is a second year Masters student in Biostatistics at the Harvard School of Public Health. He has conducted research at the Cleveland Clinic Foundation, the MIT Laboratory for Computational Physiology, Harvard School of Public Health, and the LV Prasad Eye Institute in Hyderabad, India. He has taught as a laboratory teaching assistant during college, and he now serves as a statistical consultant to the Commonwealth of Massachusetts Committee on Public Health.

  • Daniela Dias-Santos

    Ela consults, coaches and teaches in design research, strategy, and innovation with i2i Experience, which she started after a career as a senior designer with IDEO.

  • Kathryn Field

    Dr Kathryn Field, MBBS(Hons), FRACP, DMedSc, MPH, is a medical oncologist from Australia. She completed her Masters of Public Health at Harvard University in 2013 as a Fulbright scholar and Frank Knox Memorial Fellow. Kathryn has had experience in her clinical role in phase II and III clinical trials, as a hospital investigator with recruitment and follow-up of trial participants. She is also the principal investigator of a currently-running randomized phase II clinical trial for patients with brain tumors in Australia, having been involved with the trial from conception through to near-completion. She is involved with other forms of clinical cancer research including database analysis of a large prospective cohort study in bowel cancer.

  • 14 October 2013
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  • Language: English Gb


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