Last month, Duke University and the FDA released the results of a jointly conducted study on principal investigator (PI) retention. The study was released early online, but the print version is being published in June in the journal of Contemporary Clinical Trials Communications, published by Elsevier.
The purpose of the study was two-fold: 1) to confirm that investigator retention is an issue, and 2) to identify the factors that cause PIs to stop conducting FDA-regulated trials.
And confirm the retention issue it did! The results revealed a whopping 54.2% turnover rate among PIs. That is to say that more than half of the PIs who conduct a single study STOP. In fact, the article is titled, “One and done: Reasons principal investigators conduct only one FDA-regulated drug trial.”
I recommend reading the whole article – it’s really interesting and insightful – but here are the primary reasons the study revealed behind the one-and-done phenomenon:
- Workload balance (balancing trial implementation with other work obligations and opportunities) @ 63.8%
- Time requirements (time to initiate and implement trial; investigator and staff time) @ 63.4%
- Data and safety reporting @ 56.5%
- Dissatisfaction with finance-related issues @ 46.0%
Now that we have these incredibly helpful insights (thank you, Duke and the FDA!), what do we do with them? Luckily, my colleague, Param Singh, who is the director of our clinical operations solutions team, recently conducted a 30-minute webinar on this very topic. If you missed it, you can watch the recording below.