Enhancing Diversity and Inclusion in Clinical Trials.

Women and people from most racial and ethnic groups in the United States have historically been under-represented in clinical trials of investigational medical products. Inadequate representation of these groups may lead to an incomplete understanding of the safety and efficacy of new drugs, devices, biologics, and vaccines, and limit the generalizability of trial findings. As a result, new medical products may not be beneficial to all people who need them, and existing inequities in outcomes among various population groups may remain unchanged or worsen, or new disparities may arise. Although much work has focused on study-level strategies, research organizations must make systemic changes to how clinical trials are envisioned and implemented to achieve sustainable support for diversity and inclusion in clinical trials. The Clinical Trials Transformation Initiative (CTTI) conducted interviews with leaders at institutions that conduct clinical trials to explore perspectives on organizational-level practices that promote diversity and inclusion in clinical trials. Leaders described motivations, such as an ethical and moral imperative; organizational practices, such as staff investment and resource allocation; perceived return on investments, such as better science; and deterrents, such as cost and time. The CTTI also convened an expert meeting to discuss the interview findings and provide guidance. We present the interview findings and expert guidance in a framework that describes four key areas-commitment, partnerships, accountability, and resources-on sustaining organizational-level approaches for improving diversity and inclusion in clinical trials, with the ultimate goal of advancing health equity. Institutions who conduct and support clinical trials should implement organizational-level approaches to improve equitable access and diverse patient participation in clinical trials.

A Systematic Review of Interventions to Improve Initiation of Mental Health Care Among Racial-Ethnic Minority Groups.

OBJECTIVE: The objective of this systematic review was to identify interventions to improve the initiation of mental health care among racial-ethnic minority groups. METHODS: The authors searched three electronic databases in February 2016 and independently assessed eligibility of 2,065 titles and abstracts on the basis of three criteria: the study design included an intervention, the participants were members of racial-ethnic minority groups and lived in the United States, and the outcome measures included initial access to or attitudes toward mental health care. The qualitative synthesis involved 29 studies. RESULTS: Interventions identified included collaborative care (N=10), psychoeducation (N=7), case management (N=5), colocation of mental health services within existing services (N=4), screening and referral (N=2), and a change in Medicare medication reimbursement policy that served as a natural experiment (N=1). Reduction of disparities in the initiation of antidepressants or psychotherapy was noted in seven interventions (four involving collaborative care, two involving colocation of mental health services, and one involving screening and referral). Five of these disparities-reducing interventions were tested among older adults only. Most (N=23) interventions incorporated adaptations designed to address social or cultural barriers to care. CONCLUSIONS: Interventions that used a model of integrated care reduced racial-ethnic disparities in the initiation of mental health care.