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 The Food & Drug Administration (FDA) released draft guidance, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials, which recommends that all sponsors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 Since the issuance of the draft guidance, many sponsors have worked diligently to draft RDPs; however, many uncertainties remain.
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.
The roundtable was held in Boston, MA on November 12, 2022. Twenty sponsors and 10 panelists 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. Read the full Executive Summary here, which outlines possible initiatives SITC could lead that would positively impact diversity in clinical trial enrollment.
To continue the conversation and outline actionable solutions, SITC will organize a virtual convening in 2023. 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.
Roundtable Organizers