Link2Trials Q&A_26

Question:
Is it allowed to supply personalized patient support to enhance treatment adherence during clinical trials?

 

Answer:

Supplying personalized patient support during clinical trials is allowed, as long as it is done in a way that does not compromise the scientific integrity of the study. The level of support that can be supplied may depend on the specific protocol of the clinical trial and the requirements of the regulatory agency overseeing the trial.

Some clinical trials may include a protocol for supplying patient support, such as reminders for taking medication, counseling services, or educational materials to improve adherence. These support services may be delivered in a variety of ways, including in-person visits, phone calls, text messages, or mobile apps.

It is important that any personalized patient support provided during a clinical trial is documented and reported, so that its impact on study outcomes can be assessed. This may involve tracking patient engagement with the support services, measuring changes in adherence behavior, and comparing outcomes between patients who received support and those who did not.

Overall, while personalized patient support can be beneficial for improving adherence in clinical trials, it is important to ensure that the support does not compromise the scientific integrity of the study and that any impact on study outcomes is carefully evaluated.