ICT: How can companies identify if a clinical trial needs rescue?
Leslie Jones: It’s certainly a very big decision to make and no sponsor will take changing their CRO lightly. However, there naturally comes a point when missed timelines become critical. Continually failing to meet patient enrolment targets is a major red flag, but it’s important to also look at the reasons behind this. Could these problems have been foreseen or are they a result of poor planning on how and where to recruit patients, poor site selection, and/or poor patient involvement/ retention throughout the study?
Another common problem is vendors ‘lowballing’ their initial cost estimates to win the business, which leaves the CRO under resourced once the complexities of the trial become clear. It is not uncommon for CROs to dedicate less management energy and attention in cases where the sponsor is smaller or medium-sized, but, conversely, this may be the client that requires the most active oversight.
However, ultimately, the decision can come down to whether trust has been broken in the relationship between sponsor and CRO. When all members of the team agree it will be best to change the CRO, it is important to act on this decision and select a replacement with a rescue track record and experience.
|
