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 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.
- 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.
- Best Practices for Sponsors and Clinical Trial Sites: 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.
Diversity of Participants in Clinical Trials Better Practice Materials
|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.|| |