Participating in Clinical Trials

Clinical trials are voluntary research studies, conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.

• Basic Questions and Answers about Clinical Trials (En Español)
• Why Volunteer? Clinical Trials of Medical Treatments
  Illustrated PDF version [339KB]
• Protecting America's Health Through Human Drugs  
  A collection of articles about drug development and regulation, from test tube to patient.
• FDA 101: Clinical Trials and Institutional Review Boards
  A brief overview of how research subjects are protected in clinical trials, institutional review boards (IRBs), and informed consent.
• Protection of Human Subjects of Research
  Informed Consent Regulations, which outline required elements of informed consent, and explain basic structure of the informed consent process.
• Good Clinical Practice
  Resources about clinical trials and clinical trial oversight, including information for Clinical Investigators, Institutional Review Boards, Study Sponsors, and Contract research Organizations
• Should Your Child Be in a Clinical Trial?
  Information about the importance of clinical trials in knowing how products work in children, and advice about evaluating potential risks and benefits, and making decisions about trial participation. 
• Interactive patient education tutorial on clinical trials at the National Library of Medicine's MedLine Plus Web site. (En Español)
• National Library of Medicine's Medline Plus Web site provides additional basic information about clinical trials.
• ClinicalTrials.gov
  A searchable registry of federally and privately supported clinical trials conducted in the United States and around the world, providing information about a trial's purpose, who may participate, locations, and phone numbers for more details.
• Reporting Complaints Related to FDA-Regulated Clinical Trials
  Where to report complaints related to FDA-regulated clinical trials
• Public Service Print Announcement produced as part of an FDA partnership to encourage clinical trial education:
  • Low resolution PDF (72 KB)
  • High resolution PDF (12 MB) for print purposes
  • 12X18" poster version (High resolution PDF, 13 MB)

Other sizes available on request. Please e-mail dpapubs@fda.hhs.gov for further information.

Food and Drug Administration Modernization Act (FDAMA) Section 113 and ClinicalTrials.gov

• In November 1997, Congress included a provision in the Food and Drug Modernization Act (FDAMA) to mandate that the National Institutes of Health (NIH) establish, maintain, and operate a public resource for information on efficacy studies of drugs, including biological drug products, to treat serious or life-threatening diseases and conditions conducted under the FDA's investigational new drug (IND) regulations.
• Historical perspective on the development of ClinicalTrials.gov, and an overview of FDA's role in supporting the success of the database, and accessibility to clinical trials information by the public.

Information on Other Government Web Sites

• ClinicalTrials.gov: The National Library of Medicine (part of NIH) maintains this interactive database that can help you locate clinical trials for serious illnesses.
• Understanding Clinical Trials: Additional information at ClinicalTrials.gov
• Medline Plus: Resources to help you understand clinical trials through tutorials, references, and more.
• What is an AIDS Clinical Trial? The National Library of Medicine (part of NIH) provides basic information about trials and questions to ask if you are considering participating in a clinical trial. (En Español: ¿Qué es un ensayo clínico sobre la infección por el VIH/SIDA?)