Is there potential overlap in what might be considered for a clinical management trial protocol and a proof of concept study?
Yes. There are therapeutic interventions that could go in either category. If, for example, a treatment approved for a condition other than asthma is being considered for a trial in asthma, it might typically be considered as a novel approach for a proof of concept study. However, there may be sufficient data and rationale to move the study to a larger, clinical management trial. The applicant should select a category based on his/her assessment of the readiness of the intervention for a full scale clinical trial and justify the approach accordingly.
