Key design and analysis principles for quality of life and patient-reported outcomes in clinical trials.

Author(s): Unger JM,  Vaidya R,  Gore JL

Journal: Urol Oncol

Date: 2019 May

Major Program(s) or Research Group(s): NCORP

PubMed ID: 29572075

PMC ID: PMC6148417

Abstract: Advances in early detection and therapy have increased the number of prostate cancer survivors, leading to a greater emphasis on examining patient-reported outcomes (PROs). PROs augment clinical outcomes, providing a more comprehensive assessment of the patient experience, including symptoms and quality of life, that may impact the overall evaluation of new therapies. The successful incorporation of PROs into clinical trials requires adherence to key design and analysis principles. We present these principles and argue that adherence to these principles is vital to ensure valid interpretation of clinical trial findings, identify meaningful differences among investigational strategies, and better translate clinical trial results to diverse stakeholders.