Clinical Trials

About Clinical Trials

For a brief introduction to clinical trials, see AIDS InfoNet’s Participating in a Clinical Trial and How HIV Drugs Get Approved.

For a video introduction, see Clinical Trials Part 1 and Part 2 from the AIDS Library’s YouTube page (created and narrated by Val Sowell for Frontline TEACH!).

To better understand clinical trials, the National Institutes of Health (NIH) publishes a lot of useful Background Information, including:

• Understanding Clinical Trials
• A Glossary of Clinical Trials Terms

For news about clinical trials, see the NIH’s Clinical Trials News page and their What’s New page, with updates of recently added or modified studies.

To learn more about the major organizations sponsoring HIV clinical trials, see the University of California San Francisco’s HIV Research Groups and Organizations webpage.

To see a map of federal HIV/AIDS research centers, with links to each hosting organization’s website, see the National Institute of Allergy and Infectious Diseases’s Centers for AIDS Research (CFAR) map.

For a brief history of clinical trials (not HIV-specific) see the Canadian Medical Association’s A Short History of the Clinical Trial.

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How to Get Involved in Clinical Trials

People considering joining a clinical trial, may want to first read the AIDS Community Research Initiative of America’s Should I Join a Clinical Trial?

For a longer consideration of these issues, see the San Francisco AIDS Foundation’s A Guide to Clinical Trials, Part 1 and Part 2.

To find out about current clinical trials, and to learn how to participate in these trials, see the NIH’s webpages:

• Search for HIV/AIDS Clinical Trials
• ClinicalTrials.gov – not HIV-specific

At both sites, you can customize your search based on age, population, type and stage of research and more.  At the ClinicalTrials.gov site, there is a Map of All Studies   where you can browse where clinical trials are taken place all over the country and the world.

The NIH also publishes Animated Tutorials on how to search for clinical trials.

The Body.com also collects several other clinical trial databases, at their webpage on Open Clinical Trials.

Anyone participating in a clinical trial must sign informed consent documents.  For more on informed consent, see:

• The National Cancer Institute’s A Guide to Understanding Informed Consent – not HIV-focused, but relevant and more readable than the next two links
• The U.S. Department of Health & Human Services Informed Consent FAQs
• The FDA’s Guide to Informed Consent – Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators – aimed at researchers not participants, but useful if you want to know what expectations the researchers have for themselves

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Concerns About Clinical Trials

Clinical trials are medical experiments on humans, so there is reason for folks to be concerned about them.  For government statements about clinical trial concerns, see the FDA’s page on Participating in Clinical Trials, including information on:

• Clinical Trials of Medical Treatments: Why Volunteer?
• Informed Consent Regulations
• Role of HIV Drug Resistance Testing in Antiretroviral Drug Development

For more information on the ethical concerns about HIV clinical trials and about experimenting on humans, see:

• The World Health Organization’s Ethical issues raised by the HIV/AIDS epidemic
• The NIH’s Office of Human Subjects Research Regulations and Ethical Guidelines and Information Sheets and Forms
• The University of California San Francisco’s Ethical Dimensions of HIV/AIDS: Research Ethics (with full citations to scholarly articles about this subject)
• The University of Pennsylvania’s Center for Bioethics webpage Logistical and Ethical Considerations in HIV Vaccine Clinical Trials

A lot of concern about human experimentation comes from the history of the Tuskegee Syphilis Study.  To learn about that study see:

• The U.S. Centers for Disease Control and Prevention’s U.S. Public Health Service Syphilis Study at Tuskegee
• National Public Radio’s Remembering Tuskegee
• The Body Positive’s The Legacy of Tuskegee: AIDS and African-Americans
• The National Academy of Engineering’s Tuskegee Syphilis Study case study
• The book Bad Blood by James H. Jones, a history of the study, available in the AIDS Library!