Abstract
The article by Sunita VS Bandewar in the January-March issuedoes an excellent job of describing the controversy over informed consent in the SUPPORT clinical trial. As one of the authors of the duelling articles Bandewar cites, I commend the author's conclusions calling for disclosure not only of randomisation in so-called "standard of care" clinical trials, but also the comprehensive disclosure of risks in this type of research (also known as "comparative effectiveness research [CER]"). Bandewar surmises that the disclosure of randomisation could result in a "much higher chance of patients declining to participate in a randomised trial"; and that this may be one of the motives of those who argue for non-disclosure of randomisation. In fact, at least some supporters of limited disclosure of the risks in CER trials have expressly acknowledged their concerns about the recruitment of participants if all the risks of "standard of care" treatments are mentioned in the consent forms.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.