There may be a need to monitor the outcomes of patients being treated with the medicine. If this is needed, it will be stated in the AWMSG recommendation. Clinicians may be asked to support AWTTC data collation and analysis e.g. patient numbers and outcome data. AWTTC will discuss with clinicians and MA holder the most appropriate data to collect, the methods for collection and how such data will be reported and shared.
It is crucial that appropriate patient outcomes are monitored when off-label medicines are prescribed. Outcome data, including patient numbers, are an important part of the review process and are used by AWTTC to inform the review report (see Section 9.2). Clinicians are responsible for providing AWTTC with patient numbers and outcome data. AWTTC will discuss with clinicians the most appropriate data to collect, the methods for collection and how such data will be reported and shared.