Organizations driving policy changes often conduct research and generate many reports to gather best practices and develop recommendations. Turning these research results and recommendations into behavioral change is a challenge. This case study illustrates how IVT collaborated with one entity—The Clinical Trials Transformation Initiative (CTTI)—to develop a Quality by Design (QbD) approach that accomplishes just that.
CTTI had completed a significant amount of research on best practices to increase the quality and efficiency of clinical trials. Their desire was to use this research to encourage clinical trials to utilize QbD—an approach that focuses resources on the errors that matter to decision making during a trial. Avoiding inaccuracies, collecting data that is fit-for-purpose, and reducing patient burden are just a few examples of the many benefits of applying QbD. IVT worked in collaboration with the CTTI QbD team to conceptualize, design, and implement an online “one size fits all” Toolkit to bring these recommendations into practice by the wider clinical trials community. IVT recommended and implemented a three-step approach to QbD: learn, teach, and adopt. We developed numerous graphics, tools, and web presentation strategies that were visually appealing, easy to understand, easy to locate, and facilitated adoption by Toolkit users.
Together, IVT and CTTI developed an easy-to-use Toolkit to encourage adoption of a QbD approach to clinical trials. Numerous organizations leading clinical trials have used material from CTTI’s QbD Toolkit to help their teams understand QbD principles and learn how the approach can optimize a trial’s chance of success. CTTI has collected multiple case studies demonstrating the adoption and impact of QbD by clinical trial coordinators.