Patient-reported outcomes in drug safety evaluation.

摘要

The current standard method for adverse symptom monitoring in clinical trials is staff reporting [1, 2]. This is generally conducted via a complex process of data transfer, during which clinicians interview patients and then document impressions in medical charts ad hoc; study personnel abstract these charts and convert reported symptoms to a standard lexicon such as the Common Terminology Criteria for Adverse Events (CTCAE) or MedDRA (Medical Dictionary for Regulatory Activities); and then terms are entered manually into a database.