Clinical Trials FAQs

Because the agencies’ roles are different, the Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) have different definitions of research.

DHHS has defined research or “clinical investigation” as a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

The FDA has defined clinical investigation as, “…any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA…or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.”

Clinical trials are specific types of studies that are grouped in categories as well as phases, depending upon the purpose and goals of the study. View descriptions of the types of clinical trials, including the differences between phase I, II, III and IV studies.

There are general and specific risks to those who participate in a clinical trial. Specific risks of the study that have been seen in animals or human subjects will be outlined in the study documents. Some of the general risks include:

• The treatment may not be effective
• The side effects may be unpleasant, serious or even life-threatening
• The study may require a greater commitment of the patient’s time and travel for treatments, tests, and physician or hospital visits
• Although coverage for a procedure can’t be denied solely based on a patient’s participation in a research study, the patient’s health insurance may not cover the costs associated with the study

More time may be required of you if your patient receives standard of care treatment. Clinical research studies are carefully planned to ensure each patient meets the same eligibility criteria and is undergoing the same processes and procedures in the same way. Because of this, you will need to attend protocol training, and stay up-to-date on any changes that are made to the protocol.

Additionally, more safety information is typically required from patients who are participating in a clinical research study, so you may have to review and sign off on more tests and procedures than you are used to.