|
The recent draft guidance issued by the FDA underscored the importance of patient reported outcomes (PRO) in clinical trials. The guidance focused on evaluating the appropriateness and adequacy of PRO in medical product development to support labelling claims. The guidance laid out a blueprint for the evaluation of PRO data collection methods used during clinical trials. Due to the complex nature of this subject, industry experts found that the guidance raised more questions than it answered.
THE FDA GUIDELINES
The use of PRO data is vital to the FDA when issuing labelling claims. Patient reports can be the only way to reliably collect assessments pertaining to subjective information, such as the perception of pain and fatigue. It is essential that this data be captured efficiently, using a validated and unbiased instrument. The FDA has acknowledged the need for clarification regarding the validation of electronic instruments, and by issuing this guidance, has further highlighted the traditional arguments of paper-based versus electronic methods of data capture. |
