TransCelerate has long been recognized as a facilitator of cross-industry knowledge and data sharing. We are leveraging this strength by developing solutions to equip sponsors and ecosystem stakeholders with the tools and resources needed to improve outcomes for the diversification of participants in clinical trials. The following efforts are underway with new resources available as part of our Diversity of Participants in Clinical Trials Initiative.
The Clinical Research Diversity Collaboration Hub is a“one-stop shop” that collects and shares information and insights across the ecosystem. It includes diversity roundtable events, experience-based resources for sponsors, a diversity regulation landscape assessment, and pragmatic toolkits inclusive of templates and tools to be leveraged by the broader ecosystem.
| Resource Name | Description | Materials |
|---|---|---|
| Diversity Community-Based Site Engagement and Capacity Building | This solution provides an aggregated collection of insights and perspectives from the attending organizations of a June 9 Roundtable Event, regarding considerations that sponsors, sites, and others have taken to enhance engagement and capacity building for community-based sites. | Diversity Community-Based Site Engagement and Capacity Building |
| Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT) | This toolkit is comprised of a set of mitigation considerations designed to support efforts to sustainably partner with sites to enable the enrollment and retention of underrepresented patient populations in clinical trials. These mitigation considerations consist of perspectives from a series of stakeholder discussions and a Diversity Roundtable event and suggest considerations across different maturity levels. | Sponsor Toolkit Site Engagement and Capacity Building Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT) |
| Sponsor Toolkit Portfolio and Program-Level Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT) | Our toolkit is designed to support sponsor efforts to leverage key portfolio and program/compound level diversity considerations to facilitate meaningful* inclusion of diverse patient populations in the drug development lifecycle. The inclusion of diverse patient populations in clinical trials is of increasing importance to health authorities including the US Food and Drug Administration and more inclusive trial practices are being strongly encouraged. To address this call to action, this toolkit includes guidance for sponsors across sponsors’ portfolio and compound development. * Integrated design and operational strategies that support the generation of robust actionable data for diverse patient populations | Sponsor Toolkit Portfolio and Program-Level Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT) |
| U.S. Regulatory Landscape: Diversity in Clinical Trials | This regulatory landscape resource is designed to help identify key U.S. legislation and U.S. FDA policy, regulation, and guidance as well as regulatory precedent to consider when working to understand and improve diversity & inclusion (D&I) of adult patients in clinical trials, focusing on the inclusion of racial and ethnic minorities. | U.S. Regulatory Landscape: Diversity in Clinical Trials |
| Reference Table and Landscape of Available Resources | Descriptions and links to publicly available resources for Patients, Sponsors, and Sites/HCPs. Also includes a visual landscape of the resources described and linked in the reference tables. The landscape also indicates resources that serve overlapping stakeholder communities. | Reference Table and Landscape of Available Resources |
Identify priority disease states with disparity between disease prevalence and study representation among racial or ethnic groups to establish a current state benchmark for tracking future progress.
As part of our earlier efforts to promote awareness of the need for greater representation in clinical trials, TransCelerate released the following considerations for sponsors and sites to improve recruitment of diverse populations.
| Better Practice Area | Guidance Description | Related Materials |
|---|---|---|
| Diversity Awareness for Sites & Sponsors | Provides sponsor companies with information and tools to help raise awareness of the need to achieve clinical trial populations which are representative of the target indication. Materials also provide tools and guidance which may be used by sites to increase clinical trial participation of minority patients. | |
| Patient Engagement | Provides sponsor companies with guidance on approaches for patient engagement and how they can successfully be used to enable recruitment and retention of minorities within clinical trials. | |
| Cultural Competency | Provides information to sponsor company study teams to help raise awareness at the site level of the benefits of cultural competency and provide guidance on how and when to use available resources. | |
| Reimbursement IRB Insights | The objective of this content is to reduce time and effort of sponsor study teams when making decisions on what and how much can be reimbursed by:
| |
| Informed Consent Short Form | Provides sponsor companies with tools to increase clinical trial participation for patients with limited English proficiency and low health literacy/numeracy. | |
| Community Engagement for Sites | The objective of this content is to provide sites used by sponsor organizations with tools to recruit minority populations by engaging with local community organizations. Content provided is intended for staff at sites, and therefore should be shared with anyone responsible for engaging with or supporting sites, including Site Managers, Site Monitors and Site Liaisons. |