Posted by Michael Wonder on 13 Sep 2018
BIO, Allergan and Roche call for FDA flexibility with patient experience data
13 September 2018 - Industry group BIO and biopharma companies Allergan and Roche are calling for the FDA to be flexible in its approach for using patient experience data and in allowing the use of such data in labelling.
BIO said that it “strongly believes” that in order for a broad adoption of patient experience data (PED), any upcoming guidance documents on patient-focused drug development “should emphasize the FDA’s willingness to exercise regulatory flexibility and acceptance of innovative designs and approaches for collecting PED.”
For example, the draft guidance on gathering patient input, according to Danielle Friend, director of science and regulatory affairs at BIO, is “highly focused on statistical requirements for collection of subjective measures and although representation of the population is paramount, there is also a need to balance such representativeness with statistical validity, as the requirement of many strata for representation could have a negative impact on statistical power.”
