TY - JOUR
T1 - Increasing Diversity in Clinical Trials
T2 - Overcoming Critical Barriers
AU - Clark, Luther T.
AU - Watkins, Laurence
AU - Piña, Ileana L.
AU - Elmer, Mary
AU - Akinboboye, Ola
AU - Gorham, Millicent
AU - Jamerson, Brenda
AU - McCullough, Cassandra
AU - Pierre, Christine
AU - Polis, Adam B.
AU - Puckrein, Gary
AU - Regnante, Jeanne M.
N1 - Publisher Copyright:
© 2018 The Authors
PY - 2019/5
Y1 - 2019/5
N2 - Clinical trial results provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. Efficacy and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including sex, age, race, ethnicity, lifestyle, and genetic background. Racial and ethnic minorities continue to be underrepresented in cardiovascular and other clinical trials. Although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proved elusive. We investigated barriers impacting minority patients’ willingness to participate in trials and—based on literature review and evaluation, and input from key stakeholders, including minority patients, referring physicians, investigators who were minority-serving physicians, and trial coordinators—formulated potential solutions and tested them across stakeholder groups. We identified key themes from solutions that resonated with stakeholders using a transtheoretical model of behavior change and created a communications message map to support a multistakeholder approach for overcoming critical participant barriers.
AB - Clinical trial results provide the critical evidence base for evaluating the safety and efficacy of new medicines and medical products. Efficacy and safety may differ among population subgroups depending on intrinsic/extrinsic factors, including sex, age, race, ethnicity, lifestyle, and genetic background. Racial and ethnic minorities continue to be underrepresented in cardiovascular and other clinical trials. Although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proved elusive. We investigated barriers impacting minority patients’ willingness to participate in trials and—based on literature review and evaluation, and input from key stakeholders, including minority patients, referring physicians, investigators who were minority-serving physicians, and trial coordinators—formulated potential solutions and tested them across stakeholder groups. We identified key themes from solutions that resonated with stakeholders using a transtheoretical model of behavior change and created a communications message map to support a multistakeholder approach for overcoming critical participant barriers.
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U2 - 10.1016/j.cpcardiol.2018.11.002
DO - 10.1016/j.cpcardiol.2018.11.002
M3 - Review article
C2 - 30545650
AN - SCOPUS:85057968872
SN - 0146-2806
VL - 44
SP - 148
EP - 172
JO - Current Problems in Cardiology
JF - Current Problems in Cardiology
IS - 5
ER -