ClinicalTrials.gov - Information on Clinical Trials and Human Research Studies


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Links to General Information on Clinical Trials

The following U.S. government web sites guide consumers to answers to questions and provide contacts to clinical trials, and to information on drugs and important health care issues. The clinical trials discussed in these sites are all available in ClinicalTrials.gov.

Clinical Trials at the National Institutes of Health.

The NIH Clinical Center in Bethesda, Maryland is the research hospital of the National Institutes of Health (NIH). There, through clinical research, scientific discoveries in the laboratory are translated into new and better medical treatments and therapies for people.

Their web site guides potential participants, their families and physicians about participating in clinical trials in Bethesda, Maryland:
http://www.cc.nih.gov/

Recruitment information for sick or healthy participants:
http://www.cc.nih.gov/ccc/prrc/info.html#patients

Cancer Trials

The National Cancer Institute (NCI) is the U.S. government's focal point for clinical trials on cancer. Most U.S. government agencies that conduct cancer research, such as DOD or VA, do so in partnership with NCI.
http://www.nci.nih.gov/

NCI provides information on understanding cancer trials, types of cancer, finding trials, resources for researchers, most requested pages, and more:
http://www.cancer.gov/clinical_trials/

NCI Clinical Trials Education Series provides publications for individuals and health care professionals to understand clinical trials, such as self-paced workbooks, slide programs on CD-ROM, booklets and videos:
http://www.nci.nih.gov/clinicaltrials/resources/clinical-trials-education-series

The Veterans Administration (VA) and NCI provide information on their interagency partnership agreement in clinical trials for cancer:
http://www.va.gov/cancer/

The FDA Cancer Liaison Program, Office of Special Health Issues with NCI answers questions directed to FDA by participants, their families, and participant advocates about therapies for life-threatening diseases:
http://www.fda.gov/oashi/cancer/cancer.html

Vision Trials

The National Eye Institute (NEI) provides a clinical studies database, vision research information, and free education resources:
http://www.nei.nih.gov/resources/

Mental Health Trials

National Institute of Mental Health (NIMH) supports FAQs for potential participants in mental health research; read "A Participant's Guide to Mental Health Clinical Research":
http://www.nimh.nih.gov/Publicat/clinres.cfm

Information on Bioethics

NIH Office of Extramural Research (OER), and the NIH Inter-Institute Bioethics Interest Group
OER provides information on policies and regulations, Institutional Review Board resources, guidance for clinical investigators, research resources, courses and tutorials on bioethical issues in human studies:
http://www.nih.gov/sigs/bioethics/

The National Library of Medicine (NLM) compiled a comprehensive bibliography from 1989 through November 1998, "Ethical Issues in Research Involving Human Participants,"compiled by the National Library of Medicine:
http://www.nlm.nih.gov/pubs/cbm/hum_exp.html

HHS Office of Human Research Protection (OHRP)
OHRP provides a guide and training materials on regulations and procedures governing research with human subjects; includes a guidance document on financial relationships in clinical research:
http://www.hhs.gov/ohrp/

Information on Medicare Coverage

Centers for Medicare and Medicaid Services (CMS)

CMS provides information on the September 19, 2000 final national coverage decision regarding Medicare payments for routine costs, and reasonable and necessary items in clinical trials; read "Medicare Coverage Policy ~ Clinical Trials." This decision is based upon the authority found in §1862(a)(1)(E) of the Social Security Act
http://www.medicaid.com/coverage/8d2.asp

Clinical Trials and Medicare Quick Reference Guide
http://www.medicaid.com/medlearn/refctmed.asp

MedlinePlus Clinical Trials "Health Topics" Information

MedlinePlus is a web-based information service from the National Library of Medicine. Its "Health Topics" section has extensive information from NIH and other trusted sources on over 550 diseases and conditions, including a link to clinical trials. It also includes an informative "Clinical Trials" health topic page, with some material in Spanish, and an interactive tutorial on clinical trials.
http://www.nlm.nih.gov/medlineplus/clinicaltrials.html

Information on Drugs

The Food and Drug Administration is the U.S. government agency responsible for ensuring the safety and effectiveness of all drugs. After a clinical trial, it looks at the evidence to determine if a new drug or treatment is safe to approve as a marketable new product and is an improvement over the standard therapy (See Approved Drugs). FDA web sites provide valuable information to consumers on its activities in regulation and approval of drugs.
http://www.fda.gov/

FDA provides the following general information about newly approved prescription drugs:

Information on how drugs are developed in the U.S., read "From Test Tube to Participant: New Drug Development in the U.S.," third Edition, September, 1999:
http://www.fda.gov/cder/about/whatwedo/testtube.pdf

Consumer information about drugs approved since 1998:
http://www.fda.gov/cder/consumerinfo/

Information on products regulated by FDA:
http://www.fda.gov/cder/drug/

New and generic drug approvals since 1988:
http://www.fda.gov/cder/approval/

FAQs to CDER:
http://www.fda.gov/cder/about/faq/

The FDA Electronic Orange Book, which gives current approved drug products:
http://www.fda.gov/cder/ob/

MedlinePlus Drug Information.

MedlinePlus Guide to over 9,000 prescription and over-the-counter medications:
http://www.nlm.nih.gov/medlineplus/druginformation.html

Last updated: 10 September 2004

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National Institutes of Health, Department of Health & Human Services