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 a part of our Diversity of Participants in Clinical Trials Initiative:
- Clinical Research Diversity Collaboration Hub: This “one-stop shop” will collect and share information and insights across the ecosystem and include diversity roundtable events, experience-based guidance for sponsors, and a diversity regulation landscape assessment, and development of pragmatic toolkit inclusive of templates and tools to be leveraged by the broader ecosystem. This team has produced the following:
- Sponsor Toolkit Program and Portfolio-Level Considerations for Diversity, Equity and Inclusion of Participants in Clinical Trials (DEICT) – A set of considerations to support sponsors with improving diversity in clinical trials related to protocol design/development.
- US Regulatory Landscape: Diversity in Clinical Trials – A resource for the US 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.
- Roundtable Reference Table and Landscape of Available Solutions – Conducted a roundtable event with resources available to help the broader ecosystem.
- Race & Ethnicity Enrollment Data Benchmarking: 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.
- Leveraging Our Existing Solutions: Investigating ways to improve diversity of participants in clinical trials by leveraging TransCelerate’s existing set of assets, such as the recent success story surrounding our Patient Experience Initiative’s Study Participant Feedback Questionnaire and its translation into multiple languages for use with multiple patient populations.
- Diversity of Participants in Clinical Trials Better Practice Materials: As part of our earlier efforts to promote awareness of the need for greater representation in clinical trials, TransCelerate released the following guidance for sponsors and sites to improve recruitment of diverse populations.
|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 (PDF)|
|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 Solutions||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 Solutions|
|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.|