Testing the relevance of phase III trial endpoints with prospective prescribers
The client is a biopharmaceutical company developing a therapy to inhibit further disease progression in type 1 diabetes and has an active Phase III study. Another biopharmaceutical company is developing a competitive biologic; however, their Phase III clinical trial failed to meet its primary efficacy endpoint and this study was subsequently suspended. Our client wanted to understand the implications for their own Phase III trial from the perspective of the market and whether the subtleties in the differences between the trials are well understood or if physicians need to be extensively educated on them.
We conducted an online discussion with type 1 diabetes specialists who have participated in either of the Phase III clinical trials (our client's or the competitor's). We compared and contrasted the studies to understand if there would be a negative halo effect from the failed study on our client's study.
Results & Impact
We found that physicians were aware of the difference in primary endpoints between the two clinical trials, and viewed the endpoint of our client's clinical trial as appropriate. Therefore, modification to our client's trial wasn't necessary. Physicians did note, however, that a teleconference explaining the difference between the two clinical trials would prepare PIs to in turn explain the difference to patients. This would be particularly helpful in reassuring patients already unsure of participating in our client's clinical trial.