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.
Food and Drug Administration Modernization Act (FDAMA) Section 113 and ClinicalTrials.gov
- In November 1997, Congress included a provision in the Food and Drug Modernization
Act (FDAMA) to mandate that the National
Institutes of Health (NIH) establish, maintain, and operate a public resource
for information on efficacy studies of drugs, including biological drug products,
to treat serious or life-threatening diseases and conditions conducted under
the FDA's investigational new drug (IND) regulations.
Historical perspective
on the development of ClinicalTrials.gov, and an overview of FDA's role
in supporting the success of the database, and accessibility to clinical
trials information by the public.
Gender and Clinical Trials
- Enrollment of Women in HIV Clinical
Trials
An evaluation abstract of the proportion of women enrolled in federally and
privately sponsored clinical trials for HIV/AIDS therapies initiated between
1989-1994
- Equality In Clinical Trials, Drugs and
Gender, by Judith Levine Willis, September 1997
- Talk Paper: FDA Proposes Rule
on Women in Clinical Trials, September 23, 1997
- Investigational New Drug Applications; Proposed
Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening
Diseases, September 24, 1997.
FDA proposed amendments to the provisions of its regulations governing investigational
new drug applications (IND's) to permit FDA to place a clinical hold on one
or more studies under an IND involving a drug that is intended to treat a
life-threatening disease affecting both genders and are otherwise eligible
but are excluded from participation in an investigation only because of a
risk or potential risk of reproductive or developmental toxicity from use
of the investigational drug.
- Investigational New Drug Applications; Final Rule Amendment
to Clinical Hold Regulations for Products Intended for Life-Threatening
Diseases and Conditions
The Food and Drug Administration (FDA) amended the regulations governing
investigational new drug applications (IND's) to permit FDA to place a clinical
hold on one or more studies under an IND involving a drug that is intended
to treat a life-threatening disease or condition affecting both genders.
The amendments permit the agency to place a clinical hold on such studies
if men or women with reproductive potential who have the disease or condition
are otherwise eligible but are categorically excluded from participation
solely because of a perceived risk or potential risk of reproductive or developmental
toxicity from use of the investigational drug. This rule was developed in
response to the past practice of excluding women with reproductive potential
from early clinical trials because of a perceived risk or potential risk
of reproductive or developmental toxicity. The final rule does not impose
requirements to enroll or recruit a specific number of men or women with
reproductive potential.
AIDS/HIV Clinical Trials
- FDA issues a letter to all IND-holders
of antiretrovirals in the development for HIV. The purpose is to encourage
sponsors to study their drug in heavily treated patient populations with
limited treatment options, and to collaborate with other drug sponsors to
develop therapeutic options. The letter clarifies the agency's position on
combining investigational drugs in clinical trials, and designing trials
that include treatment experienced populations. This letter was drafted
in response to discussions held with respresentatives of several community
groups, at the "Salvage Workshop" in Toronto, Canada, in May 1999.
- Expanded Access and Expedited Approval
of New Therapies Related to HIV/AIDS (January 1996)
- Enrollment of Women in HIV Clinical
Trials
An evaluation abstract of the proportion of women enrolled in federally and
privately sponsored clinical trials for HIV/AIDS therapies initiated between
1989-1994
- AIDSinfo
The National Library of Medicine (part of NIH) maintains this interactive
database that can help you locate trials studying HIV/AIDS.
- What Is an
AIDS Clinical Trial?
The National Library of Medicine (part of NIH) provides basic information
about trials and questions to ask if you are considering participating in
a clinical trial. (En
Español)
Information on Other Government Web Sites
- ClinicalTrials.gov: The National
Library of Medicine (part of NIH) maintains this interactive database that
can help you locate clinical trials for serious illnesses.
- ClinicalStudyResults.org:
A central, widely accessible, web-based repository for clinical study results
in a reader-friendly, standardized format.
- AIDSinfo: The National
Library of Medicine (part of NIH) maintains this interactive database that
can help you locate trials studying HIV/AIDS.
- What
is an AIDS Clinical Trial? The National Library of Medicine (part of
NIH) provides basic information about trials and questions to ask if you
are considering participating in a clinical trial. (En
Español)
