Improving Clinical Trial Recruitment
The Challenge
A biopharma company was deep into Phase II of its clinical trial. Being a small company, there was incredible consiousness about commitments made to shareholders. In this case the commitment to shareholders was to complete Last Patient In by a specific date. It did not look like that deadline would be met. The target of the trial is a disease that disprportionally effects people of African descent. We did an analysis of where the clinical sites were vs. the intended population and realized very few of the sites were in areas that would support the recruitment. Also, the sites were highly academic where few people of color would frequent, none in real communities where an abundance of possible trial participants would be.
The Solution
We had to take a two staged approach – first, help the company comfortably understand that we would have to to geographies that are somewhat different than where the current sites were. Then, we had to also convince professionals used to handling clinical trials that a different, community-based approach would be necessary.
We built a plan that included working with advocacy groups focused on supporting non-white patients – they are already in the business of breaking down cultural barriers to clinical trial participation. We also engaged local, community-based organizations who already had the local trust and could co-ordinate efforts between the academic and community-based researchers.
The community-based approach was integrated into the company’s research DNA
Planning for Phase III
The Phase II numbers were met but the team realized the community-based approach will have to be incorporated into Phase III to successfully get the molecule to market.
Internally, new behaviors were learned
With the FDA requiring more on a real world approach to data as well as payers leaning more towards performance/outcomes based contracting recruitment of diverse populations has become more critical..
Developed non-traditional partnerships
Industry first formal partnership with CDC as the program brought value. Parnered with employers to develop internal programs, with health plans to develop member programs…unprecedented!
