Research Inclusion
Diversity among study participants in research eliminates health disparities and promotes precision medicine
SHC is committed to increasing diversity and inclusion in research by documenting the current gaps in participation and advocating for equity in precision medicine research. We will identify and share best practices of cancer centers that are successfully accruing diverse populations to their cancer trials. Through participation in clinical research, we believe that racial and ethnic minorities can benefit from the improved outcomes achieved with newer therapies and advance our understanding of disease heterogeneity across demographics for all Americans.
Find best practices and tools to promote the inclusion of diverse populations in research.
Are you searching for a clinical trial? – Featured Links from our Partners
• i- connect from WCG/CenterWatch
• Stand up 2 Cancer Trial matching service with Emerging Med’s clinical navigators
Best practices for Sponsors and Sites
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Featured Resources
The optimal patient journey based on
Cancer Center of Excellence practices
NMQF Geo map informs Trial site placement
Key Definitions
Clinical Research: The NIH statute defines “clinical research” to include clinical trials”
Minority Groups: The NIH statute states that: The term “minority group” includes subpopulations of minority groups.
Race and Ethnicity: As defined in the Office of Budget Management (OBM) 2016 Industry Guidance Document Collection of Race and Ethnicity Data in Clinical Trials.
Health Equity: Achieved when every person has the opportunity to “attain his or her full health potential” and no one is “disadvantaged from achieving this potential because of social position or other socially determined circumstances.” Health inequities are reflected in differences in length of life; quality of life; rates of disease, disability, and death; severity of disease; and access to treatment.
Health Disparities: As an example, The National Cancer Institute defines a cancer health disparity as an adverse difference in cancer incidence (new cases), cancer prevalence (all existing cases), cancer death (mortality), cancer survivorship, and burden of cancer or related health conditions that exist among specific population groups in the United States.
Precision Medicine: Precision medicine is “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” This approach will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular disease will work in which groups of people.
Selected References
Cancer Center of Excellence Strategies
Regnante JM, Richie NA, Fashoyin-Aje L, Vichnin M, Ford ME, Roy UB, Turner K, Hall LL, González ET, Esnaola NF, Clark LT, Adams HC III, Alese OB, Gogineni K, McNeil LH, Petereit DG, Sargeant I, Dang JH, Obasaju C, Highsmith Q, Craddock Lee SJ, Hoover SC, Williams EL, Chen MS Jr.: US Cancer Centers of Excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials. J Oncol Prac DOI 10.1200/JOP.18.00638 (open access)
Improving Access to Cancer Clinical Trials by Reducing the Financial Burden
Winkfield K, Cancer, October 2019.
Representative Populations in Publications
Loree, et al, Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals 2008 to 2018, JAMA Oncol. 2019;5(10):e191870. doi:10.1001/jamaoncol.2019.1870.
Solutions for Overcoming Barriers
Increasing Diversity in Clinical Trials: Solutions for Overcoming Barriers, Current Problems in Cardiology. Clark L, Regnante, J, Puckrein G et al, Published online Nov 9, 2019.
US Cancer Centers of Excellence
Coordination of operational strategies contribute to enhanced accrual of racial and ethnic minorities in clinical trials
(Coming soon)
Selected Links
Why all Stakeholders Must OWN the Mission
FDA Office of Minority Health and Health Equity (OMHHE) and Yale Center for Clinical Investigation report on Advancing Clinical Trial Diversity through Community Engagement
AACR Disparities Meeting highlights, San Francisco, Sept 2019
American Cancer Society Cancer Action Network: Barriers to patient enrollment in therapeutic clinical trials for cancer: A landscape report.
About Clinical Trials: FDA’s Office of Minority Health and Health Equity (OMHHE)
All of Us:
Drug Trials Snapshots:
FDA’s Action Plan for FDASIA Section 907:
The FDASIA Sec. 907 Action Plan recommends that medical product applications submitted for marketing approval improve their demographic subgroup data’s completeness, quality, and availability.
Find Me Cure
Future treatments within your reach
The treatments that are already available are not your only option. Inform yourself about clinical trials happening worldwide right now. We are here to provide you free access to future treatments.
The optimal patient journey based on
Cancer Center of Excellence practices
NMQF Geo map informs Trial site placement
Selected References
Regnante JM, Richie NA, Fashoyin-Aje L, Vichnin M, Ford ME, Roy UB, Turner K, Hall LL, González ET, Esnaola NF, Clark LT, Adams HC III, Alese OB, Gogineni K, McNeil LH, Petereit DG, Sargeant I, Dang JH, Obasaju C, Highsmith Q, Craddock Lee SJ, Hoover SC, Williams EL, Chen MS Jr.: US Cancer Centers of Excellence strategies for increased inclusion of racial and ethnic minorities in clinical trials. J Oncol Prac DOI 10.1200/JOP.18.00638 (open access)
Winkfield K, Cancer, October 2019.
Representative Populations in Publications
Loree, et al, Disparity of Race Reporting and Representation in Clinical Trials Leading to Cancer Drug Approvals 2008 to 2018, JAMA Oncol. 2019;5(10):e191870. doi:10.1001/jamaoncol.2019.1870.
Increasing Diversity in Clinical Trials: Solutions for Overcoming Barriers, Current Problems in Cardiology. Clark L, Regnante, J, Puckrein G et al, Published online Nov 9, 2019.
US Cancer Centers of Excellence
Coordination of operational strategies contribute to enhanced accrual of racial and ethnic minorities in clinical trials
(Coming soon)
Selected Links
Why all Stakeholders Must OWN the Mission
FDA Office of Minority Health and Health Equity (OMHHE) and Yale Center for Clinical Investigation report on Advancing Clinical Trial Diversity through Community Engagement
AACR Disparities Meeting highlights, San Francisco, Sept 2019
American Cancer Society Cancer Action Network: Barriers to patient enrollment in therapeutic clinical trials for cancer: A landscape report.
About Clinical Trials: FDA’s Office of Minority Health and Health Equity (OMHHE)
All of Us:
Drug Trials Snapshots:
FDA’s Action Plan for FDASIA Section 907:
The FDASIA Sec. 907 Action Plan recommends that medical product applications submitted for marketing approval improve their demographic subgroup data’s completeness, quality, and availability.
Find Me Cure
Future treatments within your reach
The treatments that are already available are not your only option. Inform yourself about clinical trials happening worldwide right now. We are here to provide you free access to future treatments.
FDA Office of Minority Health and Health Equity (OMHHE) and Yale Center for Clinical Investigation report on Advancing Clinical Trial Diversity through Community Engagement
AACR Disparities Meeting highlights, San Francisco, Sept 2019
About Clinical Trials: FDA’s Office of Minority Health and Health Equity (OMHHE)
All of Us:
Drug Trials Snapshots:
FDA’s Action Plan for FDASIA Section 907:
The FDASIA Sec. 907 Action Plan recommends that medical product applications submitted for marketing approval improve their demographic subgroup data’s completeness, quality, and availability.
Find Me Cure
Future treatments within your reach
The treatments that are already available are not your only option. Inform yourself about clinical trials happening worldwide right now. We are here to provide you free access to future treatments.
