FDA’s Clinical Investigator Training Helps Support the Drug Development Process

Posted on September 28, 2016 by FDA Voice

By: Leonard Sacks, M.D., and Mili Duggal, Ph.D., M.P.H.

Though many people do not know it, FDA does much more to facilitate drug approval than evaluate new drug applications. We are also actively involved in drug development well before the application stage. One important way we do this is by training scientists who conduct the clinical trials for drugs in development. This helps ensure that the drug studies conducted by investigators meet the applicable regulatory requirements and that the applications submitted meet regulatory standards.

Leonard Sacks, M.D., is Associate Director for Clinical Methodologies, Office of Medical Policy, at FDA’s Center for Drug Evaluation and Research

We are excited to announce our seventh annual Clinical Investigator Training Course, which will be held in collaboration with the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI) from November 7-9, 2016, at the Civic Center, Silver Spring, Maryland. The course is designed for physicians, nurses, pharmacists, and other healthcare professionals who are involved in the design, conduct, and evaluation of clinical trials. Participants receive training by senior FDA experts and guest speakers from industry and academia, which enables them to learn the scientific, regulatory, and ethical aspects of clinical trials.

FDA has successfully conducted the Clinical Investigator Training Course since 2009, training more than 1,000 attendees from the U.S. and other parts of the world, including Germany, Spain, Zimbabwe, and China. Over the years, participants have included healthcare professionals from government organizations, regulatory bodies, academia, industry, and the healthcare sector.

Mili Duggal, Ph.D., M.P.H., is an ORISE Fellow, Office of Medical Policy, at FDA’s Center for Drug Evaluation and Research

FDA developed this course so that investigators could learn directly from our staff and interact with them. Clinical trial investigators play a critical role in the development of medical products. They are responsible for protecting the safety and welfare of study subjects and for acquiring adequate and reliable data to support regulatory decisions. FDA recognizes that investigators should be comprehensively trained to conduct trials efficiently. The course’s goal is to develop competence and expertise among clinical investigators, improve the quality of clinical trials, and support patient safety.

As we continue to build our program, FDA will work to integrate the latest scientific information and good clinical practices into our course. We anticipate a new round of exciting discussions with our attendees this year and we invite all who are interested and wish to attend to take a look at the course website for more details. We look forward to helping many more talented researchers hone their clinical investigator skills to advance new drug development for the American public.

Leonard Sacks, M.D., is Associate Director for Clinical Methodologies, Office of Medical Policy, at FDA’s Center for Drug Evaluation and Research

Mili Duggal, Ph.D., M.P.H., is an ORISE Fellow, Office of Medical Policy, at FDA’s Center for Drug Evaluation and Research