Achieve More Diverse Trials with the AQC Site Diversity Workbook

Posted in Risk Mitigation

AQC Tool Highlight: Site Diversity Workbook

The FDA and other Regulatory Agencies have established guidelines on enhancing the Diversity of Clinical Trial Populations for the Industry. Despite promoting enrollment practices that would lead to clinical trials that better reflect the population most likely to use the drug (if approved), challenges to diversified participation in clinical trials remain and certain groups continue to be underrepresented in many clinical trials. Adopting more-inclusive enrollment practices should improve the quality of studies by ensuring that the study population is representative of the patient population likely to use the drug in clinical practice.

In alignment with FDA and other Regulatory Agency recommendations for promoting diversity of clinical trial populations, WCG Avoca has developed a Site Diversity Workbook which provides:

  • Support for inclusion of racial and ethnic minorities in clinical trials based on disease burden and the ability to analyze clinical trial data by race and ethnicity.
  • A tool for Sponsors and Investigators to assess the success of their diversified recruitment efforts and to identify areas of opportunity.
  • Assistance for Sponsors and Investigators in drawing insight needed to optimize organizational spending, improve diversity recruitment efforts, help reach patient diversification goals, and evaluate the impact on their clinical trials.

AQC Members can access the Site Diversity Workbook in the Knowledge Center here.

This is just one of many risk-based tools available to WCG Avoca Quality Consortium Members in our Knowledge Center, which consists of over 500 regulatory compliant leading practice tools and templates customizable to their organization to be inspection ready. View the current catalog of tools.

Interested in joining the AQC? Contact us and join our next monthly Knowledge Center demo.