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European Pharmaceutical Contractor

Unravelling the Maze

The recent draft guidance issued by the FDA underscored the importance of patient reported outcomes (PRO) in clinical trials.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.


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Rachael King holds an MA in Pharmacology from Cambridge University. She is a qualified ISO9001 Tick-IT lead auditor. She has a background in pharmaceutical research and information technology, with more than 15 years of ePRO and EDC experience. Prior to joining CRF Inc, she worked for etrials as Operations lead, Managing Director and Company Secretary of the UK division. Prior to etrials, Rachael worked for Pfizer UK as a Discovery Scientist, as well as in biology computing, where she specialised in laboratory information, automation systems, and real time data acquisition of physiological signals.

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