Diversity in Clinical Trials

CTTI Publication Investigates Organizational Practices to Promote Diversity and Inclusion in Clinical Trials

Posted on by Hannah Faulkner

A new CTTI publication, published in the Journal of Clinical Pharmacology & Therapeutics, investigates organizational-level practices for enhancing diversity and inclusion in clinical trials as one component of advancing health equity and improving health outcomes. When clinical trial participants do not reflect the populations that will use the medical product, it can limit our understanding of the safety and efficacy of the investigational medical product, restrict the availability of evidence-based treatment guidelines for vulnerable populations disproportionally burdened by disease, and delay access to innovative and potentially life-extending therapies.  

CTTI interviewed 36 senior-level leaders at 20 organizations that conduct clinical trials to gather perspectives on strategies to support diversity and inclusion in clinical research. Based on these interviews and a 2-day meeting with 53 experts, CTTI identified four key action areas to implement sustainable, organizational-level practices: commitment, partnerships, accountability, and resources. To improve equitable access and increase diversity in clinical trial populations, CTTI suggests making diversity and inclusion in clinical trials an organizational priority and defining responsibility for these efforts, establishing and maintaining bi-directional community partnerships, and allocating organizational resources that support diversity and inclusion in clinical research. The CTTI Diversity Project Team is using the findings from this research to develop recommendations and a tool for institutions to use to initiate or enhance their diversity and inclusion efforts. 

CTTI Holds Meeting to Discuss the Systemic Changes Needed to Increase Diversity in Clinical Trials

Posted on by Hannah Faulkner

The Clinical Trials Transformation Initiative (CTTI) held a two-day multi-stakeholder expert meeting on Oct. 12 & 21 to discuss the systemic changes needed to ensure that U.S. clinical trials better meet the needs of diverse populations, including racial minorities, ethnic minorities, and women. At the meeting, leaders and key stakeholders from across the clinical trials ecosystem participated in an engaging forum, informative discussions, and lively breakout sessions that shed more light on new solutions for sharing information and ensuring sufficient resource allocation to diversity, equity, and inclusion initiatives.

Meeting attendees also identified some important themes and identified opportunities to increase diversity in clinical trials:

  • The benefits are indisputable. Including a diverse population in clinical trials improves the quality of science, enhances patient trust, increases patient recruitment and retention, and improves clinical care for all patients.
  • A culture shift is needed. Organizations need to ingrain diversity, equity, and inclusion initiatives into their portfolio-level strategy and within their overall mission. They should foster bi-directional community partnerships and directly engage patients in the design and planning of clinical trials and diversity efforts from the very beginning.
  • This is a full group effort. Increasing diversity in clinical trials is a multi-stakeholder effort that will take all groups working together to achieve goals of clinical trial populations representing the populations who are affected by disease.
  • There is important work ahead of us. Meeting attendees provided feedback on CTTI’s draft maturity model, helping to create a better public resource. Suggested additions included a focus on values and guidelines that are generalizable to a wide variety of stakeholders, not just industry stakeholders, and more guidance on how organizations can measure their progress through the maturity model.

CTTI is now using these findings – along with other research results and multi-stakeholder discussions – to develop recommendations and resources for release in early 2022. The project team may host additional webinars focusing on case studies and implementation of resources.

New CTTI Project Aims to Increase Inclusion of Minority Populations in Clinical Trials

Posted on by Hannah Faulkner

The lack of diversity in U.S. clinical trials limits understanding of the risks and benefits of medical products. To address this issue, CTTI is conducting a new project to demonstrate the value of engaging racial minorities, ethnic minorities, and women in clinical trials.

The objectives of this new project include:

  • Identify organizational-level practices, and related metrics, that increase the inclusion of diverse patient populations in the development lifecycle of medical products.
  • Identify incentives & disincentives for decision-makers to invest sufficient resources in organizational-level practices that increase diversity in clinical trials.
  • Identify factors that yield a clinical, scientific, and financial return on investment from engaging diverse populations in clinical trials

CTTI will conduct in-depth interviews with key stakeholders, create real-world case studies, and develop process and outcome evaluation metrics designed to build fit-for-purpose, scalable strategies to increase diversity in clinical trials.

By collecting data that demonstrates the importance of including underrepresented patient populations, CTTI aims to help increase the participation of diverse populations throughout the development lifecycle of medical products.

Share Your Experiences: Recognizing The Need for Diversity in COVID-19 Clinical Trials

Posted on by Hannah Faulkner

COVID-19 is disproportionately impacting racial and ethnic minority communities across the United States. We are asking everyone involved in clinical trials right now – IRB professionals, investigators, sponsors, participants, and others – to share their experiences and insights for creating effective strategies to engage racial and ethnic minority patient populations in COVID-19 clinical trials.

CTTI will collect experiences and input from key stakeholders across the clinical trials ecosystem through Mon., June 8 at 11:59 p.m. ET, aggregate your feedback, and summarize best practices and insights.  Findings from the survey and the webinar will later be developed into a best practices document focusing on effective strategies to engage racial and ethnic minority patient populations in COVID-19 clinical trials.

We will publically share this information via a webinar in the near future.