Rates of and Factors Associated With Patient Withdrawal of Consent in Cancer Clinical Trials.

ABSTRACT:

Importance

Patient withdrawal of consent from a cancer clinical trial is defined as a patient's volitional cessation of participation in all matters related to a trial. It can undermine the trial's purpose, make the original sample size and power calculations irrelevant, introduce bias between trial arms, and prolong the time to trial completion.

Objective

To report rates of and baseline factors associated with withdrawal of consent among patients in cancer clinical trials.

Design, setting, and participants

This multisite observational cohort study was conducted through the Alliance for Clinical Trials in Oncology. Patient withdrawal was defined as a patient's voluntary termination of consent to participate anytime during trial conduct. Baseline patient- and trial-bas

SUBMITTER: Hillman SL 

PROVIDER: S-EPMC10288373 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature