In the past, clinical investigators learned how to conduct trials from mentors. But today, principal investigators seeking a federal grant to conduct clinical research and FDA approval for a pharmaceutical product must demonstrate their knowledge in conducting clinical trials. Some large sponsors of drug discovery projects are now requiring all members of the research team to show proof of training.
Food & Drug Administration (FDA)
The FDA offers training in good clinical trials practice, or GCP, at its location in Silver Spring, Maryland, online, and in collaboration with other agencies and organizations at regional offices.
The FDA’s Clinical Investigator Training Course is for medical professionals who participate in clinical trials that are under FDA regulations. The 3-day course covers new safety concerns, adverse event monitoring, compliance with legal and ethical aspects of clinical research, and acceptable scientific and analytic standards in clinical study design and conduct. The course is presented by senior FDA experts and guest lecturers from industry and academia.
The FDA’s 10 regional offices co-sponsor 2-day workshops -- the “FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference” -- with the Society of Clinical Research Associates (SoCRA). The workshops are presented by FDA personnel.
National Institutes of Health (NIH)
All principal researchers running NIH-supported clinical trials must successfully complete clinical trial training.
NIH offers courses on epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, FDA requirements, data management and ethical issues. Topics are presented by NIH faculty and guest faculty from the FDA, pharmaceutical industry and academic institutions.
Major courses include Introduction to the Principles and Practice of Clinical Research (IPPCR), offered annually at the NIH Clinical Center in Bethesda, Maryland, and Clinical Research Training On-Line Course for Principal Investigators, a course that can be accessed on-demand.
Principles of Clinical Pharmacology, which includes drug discovery and development as part of its introduction to pharmacokinetics and pharmacogenetics, is presented one evening a week from September to April at the NIH campus in Bethesda and is telecast to pre-approved partner sites at major academic institutions and large pharmaceutical companies.
Ethical and Regulatory Aspects of Clinical Research is presented each fall at NIH’s Bethesda campus and is open to physicians, psychologists, nurses, social workers, administrative staff and students involved in clinical research that includes human subjects.
Medical students can apply for the NIH’s full-time, 12-month Clinical Research Training fellowship held in Bethesda. The paid fellowship is supported by NIH, NIH Foundation and Pfizer.
Other NIH entities such as the National Cancer Institute and the National Institute of Neurological Disorders and Stroke offer specialized training for clinical investigators focusing on a disease field.
While clinical trial training is not generally taught as part of a medical school’s curriculum, academic institutions have begun offering specialized clinical trial training programs. The University of California-Berkley Extension offers a 4-course certificate program in clinical research conduct and management which includes classroom and online instruction.
The University of California–San Francisco offers courses geared for different audiences -- from students to professionals -- including a 2-year master's program in clinical research, an advanced training in clinical research certificate program, and a summer workshop.
Drexel University Online, a subsidiary of Philadelphia’s Drexell U., offers master level courses -- Clinical Research Organization and Management and Clinical Research for Health Professionals – and certificate programs in clinical research and quantitative principles for clinical research.
Many private companies and consultants, some whose principals have prior experience with NIH or as lead investigators for pharmaceutical companies, offer online and on-site training. The courses range from a few hundred dollars for an online course to thousands of dollars for a 2-day workshop. Examples are:
Aureus Research Consultants, Metairie, Louisiana, provides training for entry level trial coordinators to senior investigators on site, online and via CD.
The Center for Professional Innovation & Education in Malvern, Pennsylvania, offers 2-day pharmaceutical and biotech certificate courses accredited by the Accreditation Council for Pharmacy Education. Courses are offered at CPIE’s locations in Pennsylvania and Los Angeles, California, and the company also offers customized on-site training.
Clinical Research Training Online, based in Palm Coast, Florida, offers courses on FDA regulations, good clinical practice, ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines and HIPAA (Health Insurance Portability and Accountability Act ) compliance for people interested in work as clinical research coordinators and a program for physicians who plan to conduct a clinical trial.