Distinctive aspects of consent in pilot and feasibility studies

• Published in: Journal of evaluation in clinical practice Vol. 27; no. 3; pp. 657 - 664
• Main Author: Sim, Julius
• Format: Journal Article
• Language: English
• Published: Chichester, UK John Wiley & Sons, Inc 01.06.2021; Wiley Subscription Services, Inc
• Subjects: clinical trial; Clinical trials; consent; ethics; Feasibility Studies; feasibility study; Human subjects; Humans; Informed Consent; Medical ethics; Medical research; Pilot Projects; pilot study; Treatment Outcome; clinical trial; feasibility study; consent; ethics; pilot study

Prior to a main randomized clinical trial, investigators often carry out a pilot or feasibility study in order to test certain trial processes or estimate key statistical parameters, so as to optimize the design of the main trial and/or determine whether it can feasibly be run. Pilot studies reflect...