Whether you plan to perform a clinical study in the EU or the US, a principal investigator must be selected before the study can be executed. The process of selecting a clinical investigator must involve careful examination of what he or she has to offer. It is important to remember that who is selected to act as principal investigator will have a large influence on many aspects of a clinical study.
The first thing that should be taken into consideration is that an investigator is ultimately a long-term partner. He/she needs to be fully engaged in all aspects of the clinical study development, execution and outcomes. Therefore, it is important to select a principal investigator who is able to provide expert advice and guidance into the design of the clinical study. Identifying whether or not the candidate has any relevant research experience can be helpful in this process.
The investigator should also have technical expertise with your product or device and be qualified to conduct the procedure with the device. It may be beneficial to have the candidate attend preclinical laboratory or cadaveric study procedures to help assess their technical expertise.
Another factor to keep in mind is that the investigator you choose will help verify a site facility with the necessary staff and equipment to conduct your clinical study. He/she can also establish access to an appropriate patient population. It is critical to plan a study designed to test the device or therapy in an optimal setting and optimal patient population in order to understand the effects in a small sample size.
Discussing and understanding the Investigator’s approach to enrolling subjects is another significant element in the selection process. It is important to select someone who is both cautious and aggressive. A slower approach is recommended as the investigator will be able to provide feedback on the functionality of the device and the subject response. This type of approach increases the chance for issues to be identified early on; potentially protecting the subject from unnecessary risks.
There are several additional aspects that are monitored by regulatory bodies that should be reviewed to help determine an investigator who is right for you. These aspects are covered in the second part of this blog, Differences and Similarities in Investigator Selection Between the US and EU.