Optimization of patient and site engagement in the SYNCHRONIZE™ phase 3 clinical trial program for survodutide in obesity through clinical trial simulation.

INTRODUCTION: Clinical trial simulations (CTSs) are an increasingly common way to incorporate site staff and participant feedback into clinical trial design. CTSs can help overcome the unique challenges presented in obesity trials. Here, a CTS was conducted for three trials from the SYNCHRONIZE™ phase 3 program of survodutide in obesity. METHODS: Individuals meeting the inclusion criteria of the SYNCHRONIZE trials (referred to as "participants"), and clinical trial professionals with experience in conducting obesity trials ("site staff"), were recruited. Trial designs were reviewed by participants and site staff, and participant-facing materials by participants. Both groups were interviewed about these aspects of the trials. RESULTS: Overall responses to the clinical trial designs were positive. Site staff were comfortable with the inclusion/exclusion criteria and thought recruitment would not be difficult. However, they indicated that pre-screening could help ensure participants' appropriateness for the trial. Additionally, they felt steps should be taken to encourage participant engagement throughout the trial. Participants' concerns focused on optimizing training and educational materials, time commitments for the trial, and burden of data collection. Recommendations from the CTS led to changes in visit interval, increased virtual visit options, and changes in participant materials. was identified as potentially helpful by both site staff and participants. However, understanding how to implement this in clinical trials remains to be elucidated. CONCLUSIONS: These results suggest participant and site staff input from a CTS could help improve obesity clinical trial design, which may ultimately lead to more robust data and reliable clinical findings.