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.
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,
http://www.cc.nih.gov/, guides
potential participants, their families and physicians about participating in clinical
trials in Bethesda, Maryland. There is
recruitment information
for sick or healthy participants at
http://www.cc.nih.gov/ccc/prrc/info.html#patients
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
National Cancer Institute, Office of Liaison Activities Presents,
Understanding NCI: Toll-Free Teleconference Series
http://la.cancer.gov/teleconference.html
A service of the U.S. Department of Health and Human Services, offering information
on HIV/AIDS Treatment, Prevention, and Research
http://www.aidsinfo.nih.gov/
The National Eye Institute (NEI) provides a clinical studies database,
vision research information, and free education resources:
http://www.nei.nih.gov/resources/
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/health/trials/index.shtml
NIH Office of Extramural Research (OER) and the NIH Inter-Institute Bioethics Interest Group
provide 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) 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/
Centers for Medicare and Medicaid Services (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 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
The Food and Drug Administration is the U.S. government agency responsible for ensuring the
safety and effectiveness of all drugs. The FDA web sites provide information to consumers
on its activities in regulation and approval of drugs.
http://www.fda.gov/
The FDA provides the following general information about newly approved prescription drugs
on its Center for Drug Evaluation and Research (CDER) website:
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 Guide to over 9,000 prescription and over-the-counter medications:
http://www.nlm.nih.gov/medlineplus/druginformation.html