title: The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims.
abstract: The importance of appropriately and effectively incorporating the patient's voice into the evaluation of new medical products has been recognized and affirmed by regulators.(1,2,3) Patient-reported outcomes (PROs) are increasingly being assessed in clinical trials to quantify treatment benefits such as symptom relief and improved functioning. Translating PRO-based treatment benefits into labeling claims can provide information to physicians and patients and assist in prescribing decisions.(4,5) Hence, standardizing the valid and reliable measurement of PRO end points is critical.
authors: Patient-Reported Outcome Consortium, Critical Path Institute, Tucson, Arizona, USA. sjcoons@c-path.org
authors: S J
authors: SJ
authors: Coons
authors: S
authors: S
authors: Kothari
authors: B U
authors: BU
authors: Monz
authors: L B
authors: LB
authors: Burke
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D003625:Data Collection / Q000379:methods*; D004348:Drug Labeling; D023381:Endpoint Determination / Q000379:methods; D006801:Humans; D017063:Outcome Assessment, Health Care / Q000379:methods*; D015203:Reproducibility of Results; D057566:Self Report