Opt-out procedures are sometimes used instead of standard consent practices to enable
patients to exercise their autonomous preferences regarding research participation while …

Background: For pragmatic clinical research comparing commonly used treatments,
questions exist about if and how to notify participants about it and secure their authorization …

Background Participants in clinical trials frequently fail to appreciate key differences
between research and clinical care. This phenomenon, known as therapeutic …

Abstract Objectives To use the Theoretical Domains Framework (TDF) to identify barriers
and enablers to participant retention in trials requiring questionnaire return and/or …

Purpose General notification offers a possible alternative to written informed consent for
pragmatic randomized controlled trials (pRCTs). It involves patients being informed through …

Objectives: To report the attitudes and opinions of subjects in US clinical trials about whether
or not, and why, they should receive post-trial access (PTA) to the trial drug, care and …

Numerous arguments have been advanced for broadly sharing de-identified, participant-
level clinical trials data, and trial sponsors and journals are increasingly requiring it …

Unrealistic therapeutic beliefs are very common—the majority of patient-subjects (up to
94%) enrol in phase 1 trials seeking and expecting significant medical benefit, even though …

This paper addresses psychological factors that might interfere with informed consent on the
part of stable patients as potential early-phase clinical trial participants. Thirty-six …

Background The requirement to obtain written informed consent may undermine the
potential of pragmatic randomized clinical trials (pRCTs) to improve evidence-based care …