Importance Clinicians, patients, and policy makers rely on published results from clinical
trials to help make evidence-informed decisions. To critically evaluate and use trial results …

There is increasing interest to integrate collection of patient-reported outcomes (PROs) in
routine practice to enhance clinical care. Multiple studies show that systematic monitoring of …

Purpose There is growing interest to enhance symptom monitoring during routine cancer
care using patient-reported outcomes, but evidence of impact on clinical outcomes is limited …

Importance To integrate the patient perspective into adverse event reporting, the National
Cancer Institute developed a patient-reported outcomes version of the Common …

The standard approach for documenting symptomatic adverse events (AEs) in cancer
clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) …

High quality protocols facilitate proper conduct, reporting, and external review of clinical
trials. However, the completeness of trial protocols is often inadequate. To help improve the …

Medicine has been personal long before the concept of “personalized medicine” became
popular. Health professionals have always taken into consideration the individual …

Importance Complete information in a trial protocol regarding study outcomes is crucial for
obtaining regulatory approvals, ensuring standardized trial conduct, reducing research …

Abstract Purpose Symptomatic adverse events (AEs) are monitored by clinicians as part of
all US-based clinical trials in cancer via the US National Cancer Institute's Common …

Background In the phase III CheckMate 227 study, first-line nivolumab+ ipilimumab
significantly prolonged progression-free survival (co-primary end-point) versus …