Clinical Trial Diversification

The following are guidance for sponsors and clinical trial sites regarding better practices and processes for minority recruitment.

Clinical Trial Diversification 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:

  • Providing insights on what IRBs consider to be appropriate and allowable reimbursement practices for clinical trial patients
  • Providing guidance on how to reimburse while reducing the risk of coercing patients to participate in clinical trials

 

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 the 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.

 

 

 

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