DEI Roundtable

SITC Corporate Member Roundtable on Diversity in Clinical Trial Enrollment Executive Summary

Held Saturday, November 12, 2022 in Boston, MA

Roundtable Overview and Introduction

Opportunity Statement

The oncology community understands the need to ensure participants in clinical trials represent the broader patient community that will ultimately be treated using the therapies under investigation. The Food & Drug Administration (FDA) released draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials, which recommends that all sponsors submit a Race and Diversity Plan (RDP). Since the issuance of the draft guidance, many sponsors have worked diligently to draft RDPs; however, many uncertainties remain.

Sponsors are:

  • Unsure which methods are effective in increasing diversity in clinical trial enrollment
  • How the FDA will monitor the effectiveness of the RDPs
  • Whether the protocol will be reviewed poorly because of an ineffective RDP

SITC’s Call to Action

In response to the desire from SITC Corporate Members for additional clarity and direction on effective RDPs, SITC leadership developed a one-day corporate roundtable that offered opportunities for sponsors to liaise directly with FDA leadership, understand how legislative action may influence future FDA guidance, and learn from a variety of critical perspectives, including contract research organizations (CROs), principal investigators, patients, patient advocates, and major cancer centers with diverse care models.

In all, the multi-stakeholder roundtable convened nearly 20 sponsors and 10 panelists who collectively explored opportunities for SITC to facilitate collaboration, consensus, and education that will ultimately support the critical need to increase diversity in clinical trial enrollment.

Roundtable Goals

The roundtable’s primary objective was to finalize recommendations to the SITC Board of Directors on initiatives SITC might lead that positively impact diversity in clinical trial enrollment.

Roundtable Organizers

Leisha_Emens__MD__PhD.png

Leisha Emens, MD, PhD
Ankyra Therapeutics

Padmanee_Sharma__MD__PhD.png

Padmanee Sharma, MD, PhD
MD Anderson Cancer Center

John_H__Stewart__IV__MD__MBA__FACS_.png

John H. Stewart, IV, MD, MBA, FACS
LSU School of Medicine, New Orleans

Roundtable Outcomes and Next Steps

Roundtable Takeaways

Roundtable attendees, through small group breakout sessions, suggested possible initiatives SITC could lead that would positively impact diversity in clinical trial enrollment.

Collaboration & Networking

  • Hold a convening of sponsors that encourages an exchange of approaches to diversifying enrollment and publish a compilation of approaches for the broader community to access and utilize.
  • Build a pilot program that focuses on a region or city and works to establish long-term relationships within the community (churches, barbershops, salons, and check-cashing stores), building trust that ultimately will lead to increased comfort from the community to participate in clinical trials.

    Education & Research

    • Build content on diversifying clinical trial enrollment into SITC clinician education (e.g. ACIs, certificate program, Winter School, etc.).
    • Fund the translation of consent forms into various, diverse languages.
    • Explore the epidemiology of various cancers to guide the community to develop RDPs that target the right type of diversity in a particular cancer clinical trial.
    • Require SITC abstract submission to include clinical trial diversity data.

    Consensus Building

    • Work collaboratively with the FDA to outline best practices from submitted RDPs that were successful in diversifying clinical trial enrollment.
    • Lobby to bring back COVID-era policies that allowed for cross-state telehealth.
    • Create universal forms for consent and order sets.
    • Change the expectation for physician time spent educating patients on clinical trials to allow for more dedicated time with patients enrolling in clinical trials.

    SITC’s Next Steps

    The results of the Roundtable will be shared with the SITC Board of Directors and SITC’s Diversity, Equity, and Inclusion Taskforce. Both the Taskforce and the Board will utilize the recommendations from the Roundtable to set SITC DEI priorities for 2023 and beyond.

    Most immediately, the Roundtable organizers recommend that SITC hold a virtual convening in 2023 that ensures the key functionalities within sponsor companies are present. The direct outcome of the 2023 convening will be a manuscript outlining SITC's recommendations for actions each stakeholder in the clinical trial ecosystem can take to positively impact diversity in clinical trial enrollment.