The Clinical Trials Transformation Initiative (CTTI), a public-private partnership between Duke University and the FDA focused on increasing the efficiency of clinical trials, has released a detailed series of recommended best practices for interactions between patient groups and clinical trial sponsors.
The recommendations were based on information gleaned from an extensive survey of patient groups and industry and academic sponsors of clinical trials, along with detailed phone interviews and an expert meeting. The scope of the recommendations covers communication and relationship management, conflict of interest, evaluation of partnership capabilities, legal ramifications, confidentiality and metrics.
FDA's Director of the Center for Drug Evaluation and Research (CDER), Dr. Janet Woodcock, described the recommendations as one of the more useful things to come of the popular Patient-Focused Drug Development (PFDD) initiatives. MDF’s Chief Science Officer Dr. Sharon Hesterlee was part of the core working group that developed the recommendations.
Click here to download the publication.
Join the CTTI Webinar
Interested in learning more about the CTTI recommendations? CTTI will host a webinar October 15, 2015 at 12:00 PM EST to present the official recommendations and take questions. Webinar panelists will include Sharon Hesterlee, Patricia Cornett from Bristol-Myers Squibb, and Scott Weir from KUMC. Click here for more information.