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 related to increasing diversity, equity, and inclusion in clinical trials.
Developing and implementing robust clinical trials strategies to enhance inclusivity of underrepresented patient populations requires multi-stakeholder engagement and collaboration. Sponsor engagement and collaboration across each of these stakeholder groups (e.g. patient groups, clinical research sites, trade organizations, etc.) is essential to improving the representation of diverse patient populations in clinical trials as well as patient outcomes.
The available solutions as part of the Diversity of Participants in Clinical Trials initiative provide an aggregated collection of shared information and insights across the ecosystem. These solutions include (but are not limited to) 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 healthcare ecosystem.
Navigate the suite of solutions by clicking on the icons for each key stakeholder group below.
Sites
Regulatory
Sponsors
Additional Resources
Sites
Solutions to support engagement with sites (e.g., academic, private, and community-based, etc.) to enhance participation of patients from diverse populations.
Diversity Community-Based Site Engagement and Capacity Building (2022)
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.
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.
Diversity Awareness for Sites & Sponsors (2014 – 2016)
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.
- Diversity Awareness for Sponsors Webinar Read Along
- Diversity Awareness for Sites Webinar Read Along
Community Engagement for Sites (2014 – 2016)
Provides 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.
Regulatory
A solution focused on providing awareness and understanding of the regulatory landscape, used to enhance diversity in clinical trials.
U.S. Regulatory Landscape: Diversity in Clinical Trials (2022)
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, equity, and inclusion (DE&I) of participants in clinical trials, focusing on the inclusion of underrepresented patient populations.
*This solution was updated based on changes in the regulatory landscape as of November 2023
Sponsors
Solutions to support sponsor teams in the development and operationalization of diversity strategies in clinical development.
A whitepaper that details key findings from the analysis of enrollment data for diverse race/ethnicities in select disease states inclusive of suggested metrics for tracking future performance.
FDA Diversity Plan Insights & Considerations v2.0 (2024)
Provides an aggregated collection of new insights and considerations (as of Q1 2024) gathered from the member company interviews to further inform operational strategies and identify how practical implementation of FDA Diversity Plans may progress as industry thinking matures in this area.
FDA Diversity Plan Early Insights and Considerations (2023)
Provides an aggregated collection of insights and considerations gathered from the member company interviews that can help to inform operational strategies and identify how practical implementation of FDA Diversity Plans may progress as industry thinking matures in this area.
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
Reimbursement IRB Insights (2014 – 2016)
Provides insights on what IRBs consider to be appropriate and allowable reimbursement practices for clinical trial patients, as well as guidance on how to reimburse while reducing the risk of coercing patients to participate in clinical trials with the intent of reducing time and effort of sponsor study teams when making decisions on what and how much can be reimbursed.
Informed Consent Short Form (2014 – 2016)
Provides sponsor companies with tools to increase clinical trial participation for patients with limited English proficiency and low health literacy/numeracy.
Patient Engagement (2014 – 2016)
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.
Additional Resources
Supplementary tools and resources to enhance patient diversity in clinical trials.
The webinar provides details about the tools and information developed by TransCelerate’s Diversity of Participants in Clinical Trials Initiative to support organizations working to improve the representation of diverse patient populations in clinical trials. Check out the webinar presentation and recording.
Reference Table and Landscape of Available Resources (2021)
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.
Cultural Competency (2014 – 2016)
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. Please take a look at the presentation and recording for more information.