The Association of Clinical Research Organizations (ACRO) is stepping up its efforts to address the age-old problem of the lack of diversity in clinical trial populations. With its principles statement, the trade group has set out what its members will do to make clinical trials—and their own workforces—more diverse.
It is now almost 30 years since lawmakers mandated appropriate inclusion of minorities in all NIH-funded research. Yet, racial and ethnic minorities are still frequently underrepresented in clinical trials, leading to a lack of pre-approval data on how therapies will perform in real-world patient populations. The FDA recently published draft guidance to help sponsors develop race and ethnicity diversity plans—and CRO and technology provider trade group ACRO has now set out its own principles.
ACRO has created four diversity and inclusion principles and briefly unpacked what they mean. The four principles are: improving health equity through access to trials; empowering research partners, namely patients, sites and healthcare professionals; partnering with stakeholders and policymakers; and driving workforce diversity, equity and inclusion.
The first three principles address the diversity of clinical trial populations. Specific objectives covered by those principles include reducing the burden of participation for diverse communities through innovative methodologies, decentralized trial support services and digital technologies, giving trial sites training and culturally relevant materials to work with diverse communities and partnering with policymakers and regulators to promote the inclusion of underrepresented study participants.
ACRO’s fourth principle covers the makeup of the clinical research industry’s workforce. As part of that piece of its agenda, the trade group’s members plan to back programs that drive diversity and inclusion in the clinical research industry workforce, including employee retention, recruitment and development, and foster relationships with minority healthcare associations and other groups to bring new generations into clinical research.
The CROs and technology providers that form ACRO’s membership are looking to the principles to “spur further collaboration across all stakeholders and make collective progress toward a clinical research ecosystem that better serves all patient communities and is more representative of the world we live in.”