Engaging patients and investigators to optimize study design

A leading pharmaceutical company engaged patients and investigators to optimize clinical trial design. The company chose to use virtual tools to discuss how to review and assess a phase II clinical trial protocol.

The clinical development team had three primary objectives:

1. Review and discuss protocol design
2. Assess logistical considerations for the conduct of the trial
3. Confirm the primary and secondary endpoints of the trial

The clinical development team used the Within3 insights management platform to make it easy for patients and investigators to provide feedback on the proposed study design from any device, including a smartphone or tablet, whenever it was convenient for them.

First, a blinded patient session was conducted to gather feedback about key aspects of the clinical trial. Patients answered 30 questions, including “Indicate the symptoms that you feel have not responded well to your treatment” and “How do you cope with, or manage, your symptoms? How well does this work for you?”

Following the patient session, the team convened 10 investigators for two 7-day sessions. Investigators answered 32 questions, including “What specific methods would you recommend for mitigating a possible placebo effect in this study?” and “Thinking about this patient population in your practice, what key factors would you need to see in the trial design to consider participating?”

By using the Within3 platform, the clinical development team optimized the study design by:

1. Understanding logistical considerations for patients
2. Assessing patient recruitment considerations with investigators before finalizing the trial protocol
3. Validating primary and secondary endpoints with investigators