Given the complexities of reporting to multiple regulators in global clinical trials, study design needs to be driven by the information required to get the project to the next step with the minimum number of patients. Doing so may require some compromise in the type and amount of data gathered, says Bernard Coulie, CEO and chief medical officer at Belgian CRO ActoGeniX, in an announcement. ActoGeniX sometimes defers studies to a later phase if they fall outside the critical path at that point in time.
"Long before we start a clinical trial or even submit an application, we start documenting the regulators involved," he says. "We go into a continuous dialogue based on available pre-clinical data or a draft protocol and start drafting their input."
Coulie says he tries to understand regulators' thinking in addition to their processes: How they are going to review the trial, their criteria for approving the trial, the kind of documentation we need to submit and the kind of reporting required once the study is complete. "This early interaction with the different authorities is crucial," he says." It is not enough to get their opinion or scientific advice; you have to understand the local interpretation of that regulation."
- see the announcement