Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback.

ABSTRACT:

Background

Although patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation of important information in consent forms for these trials.

Methods

The study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the locat

SUBMITTER: Avinger AM 

PROVIDER: S-EPMC9938963 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature