Twenty years post‐NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

@article{Chen2014TwentyYP,
  title={Twenty years post‐NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual},
  author={Moon S Chen and Primo Nery Lara and Julie H T Dang and Debora A. Paterniti and Karen A. Kelly},
  journal={Cancer},
  year={2014},
  volume={120}
}
The National Institutes of Health (NIH) Revitalization Act of 1993 mandated the appropriate inclusion of minorities in all NIH‐funded research. Twenty years after this act, the proportion of minority patients enrolled in cancer clinical trials remains persistently low. Clinical trials are vehicles for the development and evaluation of therapeutic and preventive agents under scientifically rigorous conditions. Without representation in trials, it is projected that disparities in the cancer… 
View on Wiley
europepmc.org
271 Citations
Highly Influential Citations
2
Background Citations
44
Methods Citations
4
Results Citations
1

271 Citations

nontheraPeutic trials: it dePends

Twenty-five years after the 1993 NIH Revitalization Act mandating inclusion of participants that adequately represent the US population,1 it is apparent that researchers have not met this challenge…

Scientific and Ethical Considerations for Increasing Minority Participation in Clinical Trials

A discourse on potential mechanisms to address disparities in clinical trial accrual including the ethical considerations of financial incentives, the impact of a more stringent policy and review process for product approval from the Food and Drug Administration including a diversity mandate with an associated population black box warning is provided.

Strategies to Advance Equity in Cancer Clinical Trials.

Strategies for advancing equity in cancer clinical trials for minority groups, elderly individuals, and rural populations include optimizing clinical trial matching and working with stakeholders to develop both protocols that are inclusive of diverse populations' geographic locations, and strategies to access those trials.

Moving toward true inclusion of racial/ethnic minorities in federally funded studies. A key step for achieving respiratory health equality in the United States.

A literature search for the period from 1993 to 2013 found a marked underrepresentation of minorities in published clinical research on pulmonary diseases, particularly NIH-funded studies.

Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators

Barriers related to translation, literacy, family composition, and severity of medical diagnosis were identified and potential strategies included a focus on developing personal relationships with patients, community and patient education, centralized clinical trial administrative systems, and competency focused training and education for CRCs.

Improving African American women's engagement in clinical research: A systematic review of barriers to participation in clinical trials

Enrollment of Racial Minorities in Clinical Trials: Old Problem Assumes New Urgency in the Age of Immunotherapy.

The inadequate representation of minority patients on immunotherapy clinical trials could perpetuate outcome disparity because the unique biology of the host and the tumors from this subpopulation is not accounted for as new treatment algorithms to guide optimal use of immunotherapy are developed for use in the real world.

A Population Study of Clinical Trial Accrual for Women and Minorities in Neuro-Oncology Following the NIH Revitalization Act

Following the Revitalization Act, minorities and women remain underrepresented when compared with their demographic-specific incidence and mortality in therapeutic clinical trials for neuroepithelial tumors.

An overview of EMPaCT and fundamental issues affecting minority participation in cancer clinical trials: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

It is clear that successful recruitment of minority participants to clinical trials needs to begin with efforts to develop trusting relationships between the minority community and the research institution, and this inequity in participation contributes to the ongoing health disparities.

The impact of the globalization of cancer clinical trials on the enrollment of Black patients

The impact of the globalization of cancer clinical trials on recruitment of racial minority patients has been understudied and may be the increasing enrollment of cancer trials in countries outside the United States.
...

References

SHOWING 1-10 OF 36 REFERENCES

The inclusion of women and minorities in smoking cessation clinical trials: a systematic review.

Female representation, while commensurate with population levels, declined significantly for trials that began recruitment after 1993, and minorities continued to be under-represented in later trials; however, significant improvement in representation and analysis by race occurred.

Increasing minority participation in cancer clinical trials: the minority-based community clinical oncology program experience.

MBCCOPs have demonstrated their ability to facilitate the participation of racial/ethnic minorities in clinical trials, but the contributions that they could make to the design and conduct of minority-focused research studies merit further exploration.

Gender, Racial, and Ethnic Disclosure in NIH K-Award Funded Diabetes and Obesity Clinical Trials

Overall, disclosure of race declined over the 3 timeframes whereas individually, the disclosure of African Americans improved, and clinical trials that focused on females increased across the3 timeframes for diabetes studies but not obesity studies.

Evaluating minority recruitment into clinical studies: how good are the data?

Interpretations of 'appropriate' minority inclusion in clinical research.

Barriers to therapeutic clinical trials enrollment: Differences between African-American and white cancer patients identified at the time of eligibility assessment

This study is the first to directly compare ineligibility and refusal rates and reasons captured prospectively in AA and White cancer patients, and is consistent with earlier studies that indicated that AA patients more often are deemed ineligible and, when eligible, more often refuse participation.

Overcoming barriers to cancer clinical trial accrual

An objective of the current study was to increase awareness of CCT and SB37 through a mass multimedia campaign (MMC) in the University of California (UC) Davis (UCD) Cancer Center catchment area.

Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: have we made progress?

The current level of compliance with guidelines for the inclusion, analysis, and reporting of sex and race/ethnicity in federally funded randomized controlled trials (RCTs) is compared to that from 2004.

Why ethnic minority groups are under-represented in clinical trials: a review of the literature.

A narrative review of the available literature, based mainly on US studies, aims to make sense of the issues around under-representation by providing a theoretical reconciliation and offers a number of strategies for improving ethnic minority accrual rates in clinical trials.

Participation in cancer clinical trials: race-, sex-, and age-based disparities.

Although the total number of trial participants increased during the study period, the representation of racial and ethnic minorities decreased and were less likely to enroll in cooperative group cancer trials than were whites, men, and younger patients, respectively.