FDA Offers Methods, Research Practices for Patient Input in Drug Development

The FDA issued a draft guidance on how industry should go about asking patients what’s most important to them about how they are dealing with their disease and its treatment, to help companies better develop new drugs.

The draft offers considerations for the most common qualitative methods used for gathering patient input, including one-on-one interviews and focus groups, as well as how to go about asking effective questions.

It also details survey research methods, which are frequently used for collecting quantitative data, and the accompanying instruments used to survey patients.