Clinical Trials and Drug Development
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.
Finding HIV/AIDS Clinical Trials: Search tool to find HIV/AIDS-related clinical trials
Information about Clinical Trials
Basic Questions and Answers about Clinical Trials
Easy to understand basics about clinical trials
21 CFR 50
Informed consent regulations outlining the required elements of informed consent and explain basic structure of the informed consent process.
Interactive patient education tutorial on clinical trials
at the National Library of Medicine's MedLine Plus Web site.
National Library of Medicine's Medline Plus
Web site provides additional basic information about clinical trials.
Reporting Complaints Related to FDA-Regulated Clinical Trials Good Clinical Practice Contacts
Information about HIV Drug Development
Small Business Assistance: Frequently Asked Questions on Drug Development and Investigational New Drug Applications Laws, Regulations, Policies and Procedures for Drug Applications Role of HIV Drug Resistance Testing in Antiretroviral Drug Development(PDF - 238KB) Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data(PDF - 117KB) Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV(PDF - 343KB) Development of Vaginal Microbicides and Related Information