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For Consumers
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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.
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Information about Clinical Trials
- Basic Questions and Answers about Clinical Trials
Easy to understand basics about clinical trials - Clinical Trials of Medical Treatments: Why Volunteer?
Plain language description of clinical trials and why people volunteer to participate. - 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. - Clinical Trials.gov
The National Library of Medicine (part of NIH) maintains this interactive database that can help you locate clinical trials for serious illnesses. - Reporting Complaints Related to FDA-Regulated Clinical Trials
- Good Clinical Practice Contacts
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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 - 244KB)
- Guidance for Submitting HIV Resistance Data (PDF - 293KB)
- Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV (PDF - 343KB)
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