Case Study

Clinical Trial Design, Immunology

A clinical development team wanted to optimize the design of a clinical trial to explore the use of a dietary supplement in environments where immune health can be negatively affected.

Goals

The team recognized that investigator feedback was necessary to optimize study design. Their focus areas included:

  1. Trial duration
  2. Target population and study location
  3. Primary and secondary endpoints

Solution

The clinical development team held a 12-day session on the Within3 virtual engagement platform. By convening the advisors in a virtual, over-time format, the team was able to eliminate concerns about travel and time zone differences for a group of investigators based in North America, Europe, and Australia. The physicians answered 14 questions, including In your opinion, what should the key eligibility criteria be for this study? and Which endpoints can best assess a participant’s immune health status in a clinical trial?

Results

The session generated 36 pages of advisor feedback, with 100% of advisors agreeing that the over-time virtual advisory board format was convenient and easy to use. The clinical team successfully gathered the information required to design the trial, and achieved the following objectives:

  1. Chose a randomized trial design most suitable for investigating the impact of the supplement
  2. Identified the trial duration, study locations, and target population for the study
  3. Determined primary and secondary endpoints for the trial