Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993 — The perspective of NIH clinical trialists

Freedman, Laurence S.; Simon, Richard; Foulkes, Mary A.; Friedman, Lawrence M.; Geller, Nancy L.; Gordon, David; Mowery, Richard L.

doi:10.1016/0197-2456(95)00048-8

Cited by 280 publications

(145 citation statements)

References 2 publications

Supporting

Mentioning

144

Contrasting

Unclassified

Order By: Relevance

“…1,2 Assuring diversity in clinical trial participation is a national priority. In 1993, the most recent amendment to the National Institutes of Health (NIH) Revitalization Act (Public Law 103-43), 3 mandated the inclusion of women and minorities in clinical research and government sponsored human subject research including clinical trials. This Act states that women and minorities must be included in all clinical research studies and must be included in Phase III clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors

Baquet

Commiskey

Mullins

et al. 2006

Cancer Detection and Prevention

231

205

View full text Add to dashboard Cite

show abstract

Section: Introductionmentioning

confidence: 99%

Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors

Baquet

Commiskey

Mullins

et al. 2006

Cancer Detection and Prevention

231

205

View full text Add to dashboard Cite

show abstract

“…40 The act further states that cost is not an allowable reason for excluding minorities and that NIH will support outreach efforts to fulfill this mandate.…”

Section: Clinical Trial Participation and Health Disparitiesmentioning

confidence: 99%

Health disparities: A barrier to high-quality care

Mullins

Blatt²,

Gbarayor³

et al. 2005

American Journal of Health-System Pharmacy

104

View full text Add to dashboard Cite

Purpose-Disparities in the treatment of cardiovascular disease, diabetes mellitus, and cancer among the sexes and racial groups and possible interventions are discussed.Summary-The ongoing process to identify and reduce health disparities has engaged numerous federal agencies as they monitor the nation's progress toward policy-driven and health-related objectives. Cardiovascular disease disproportionately affects minority groups and is the leading cause of death among women in the United States, and both groups receive suboptimal care for the disease. Disparities in the treatment of diabetes mellitus in African Americans, women, patients with less than a high school education, and the elderly have been found. Many minority groups continue to suffer disproportionately from cancer. Racial disparities also exist in cancer screening and treatment. Minorities are underrepresented in clinical trials for multiple reasons, many of which may be related to cultural beliefs. At all levels of coinsurance, the poor are less likely to seek preventive care. Adherence to national screening and treatment guidelines, clinical trial recruitment and participation, addressing language and geographic barriers, and increasing access to insurance are part of the coordinated efforts required to reduce health disparities. Because pharmacists influence patients' health status directly through pharmaceutical care and indirectly by engaging patients in their treatment, it is essential for pharmacists to be able to provide culturally competent care.Conclusion-Despite significant efforts over the past several years, health disparities continue to exist, particularly among minority groups. Interventions aimed at eliminating these disparities should include ensuring cultural competence among health care providers and improving health literacy among patients.

show abstract

“…This diversity is necessary to study probable and plausible differences that already are known, to understand how and why differences in outcomes occur, and to generate hypotheses for future study. 2,12,13 Second, the Consolidated Standards of Reporting Trials (CONSORT) statement, which was published in 1996, provided guidelines to improve the reporting of clinical trials. 14,15 Randomized clinical trials are undertaken to improve medical practice.…”

mentioning

confidence: 99%

Selection and description of cancer clinical trials participants—Science or happenstance?

Swanson

Bailar

2002

Cancer

View full text Add to dashboard Cite

BACKGROUNDThe selection of clinical trials participants is a critical step in study design, because it affects the generalizability of recommendations made on the basis of trial results and public acceptance of medical research. The authors assessed the heterogeneity of subgroups in cancer treatment and prevention trials and the analysis of subgroups in the evaluation of trial outcomes.METHODSThe authors reviewed published reports (1990–2000) of cancer prevention and treatment trials from 11 journals. They report here on all Phase III cancer treatment and prevention trials that had at least 100 participants and were conducted among adults in the United States. A structured abstract was developed and used to extract data from the 261 published reports. Descriptive summaries of the abstracted data provided the information included in this systematic review.RESULTSAge and gender of study participants were reported in more than 90% of these trials, whereas fewer than 30% of the trials reported race or ethnicity. Gender was reported as an explicit criterion for participant selection primarily in studies of gender specific malignancies. Race and ethnicity were reported as explicit selection criteria for participant selection for five of the prevention trials and for none of the cancer treatment trials. The 105 treatment trials that reported including both men and women had 42,355 participants, and 38.6% of those participants were women. The 26 prevention trials that reported including both men and women had 73,995 participants, and 34.7% of those participants were women. Fifty‐seven treatment trials reported participant ethnic diversity: There were 45,815 participants, with 10.5% African‐American participants and with less than 1% Hispanic, Asian, or Native American participants. Seventeen prevention trials reported participant ethnic diversity: There were 91,741 participants, with 5.5% African‐American participants, 1.7% Hispanic participants, and less than 1% Asian or Native American participants.CONCLUSIONSCancer treatment and prevention trial reports provide scant information about participant race and ethnicity. Such studies use participant selection criteria that do not define diverse subgroups, and few subgroup analyses are conducted. Improvements in the selection, reporting, and analysis of clinical trials participants are needed. Cancer 2002;95:950–9. © 2002 American Cancer Society.DOI 10.1002/cncr.10785

show abstract

Inclusion of women and minorities in clinical trials and the NIH Revitalization Act of 1993 — The perspective of NIH clinical trialists

Cited by 280 publications

References 2 publications

Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors

Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors

Health disparities: A barrier to high-quality care

Selection and description of cancer clinical trials participants—Science or happenstance?

Contact Info

Product

Resources

About