Does history repeat itself?

if you have already planned and conducted a clinical trial, you have probably formed an opinion on the investigators, sites and even countries you worked with. Some of them were probably very successful in recruitment, overall communication, adherence to the protocol and study approval process. But some were probable less so. Some were highly experienced, some were less. Often enough, decision makers in medical device companies opt to return to the same sites and investigators with which they already have experience, regardless of the nature of that experience, just because they are already familiar with the personnel, and because the study team is already familiar with the company and the device.

Site staff previous experience with the device and with the company’s team is indeed an important factor that may save time and a learning curve once the study initiates. However, since this is not the only factor, nor the most important one, determining the success of collaboration with the site and investigator, it may be worth considering in full before automatically returning to any specific site. What was your overall impression from the study staff? How was the collaboration, the communication and dynamics? What was their recruitment rate? How was the study approval process both from the IRB and the CA perspective? What was the rate of protocol deviations and violations? The reply to all these questions translates to time that may be saved or wasted when making and automatic decision, which may by far exceed the time saved by skipping the learning curve.

History does not necessarily needs to repeat itself, unless it was a good one 🙂