A Practical Guide to Conducting In-Trial Patient Interviews

Yes. The informed consent form covers the interview, but it is good practice to restate consent at the start of each interview, confirming that the participant agrees to be interviewed and recorded. Very few participants decline, and those who do tend to say so clearly. Either way, they should always have the chance.

It depends on how the data will be used. The FDA accepts patient experience data from several countries, while other regulators, such as Japan's, expect to see data from their own patient population. There is also a scientific question. Experiences of a disease and its treatment can differ across countries and cultures, including age distributions and sensitivity around certain topics. Limiting interviews to one country removes that understanding.

No. Under ICH-GCP, the recording is the source data. Without it, it is hard to prove that the transcript is accurate, or even that the interview took place. A transcript is also an interpretation of the recording rather than a true copy, so it cannot replace the source in an audit or inspection.

Very little, if the process is set up well. With a single system for sites to access and notifications whenever a patient is ready to be scheduled, the site's part should take no more than five minutes per patient. Safety reporting can also be kept proportionate. For non-serious adverse events, interviewers can ask whether the patient has already reported the event to the site, while serious events are always reported.