The report, which examines the occurrence of such therapeutic misconception, was recently published in PLOS ONE.
“Therapeutic misconception is a longstanding problem in clinical trials,” explained Paul Christopher, MD, assistant professor of psychiatry and human behavior at Brown University and lead author of the paper.
“When present, therapeutic misconception calls into question the validity of a participant's informed consent,” he told Outsourcing-Pharma.com.
As Christopher explained, therapeutic misconception occurs when participants misunderstand the rationale behind a clinical trial, how treatment will be administered during the trial, or the extent to which a trial may benefit them.
“Once we become aware that such misunderstandings are present, we have a duty to try to correct them,” he added, noting that to ignore these misconceptions “not only devalues participants' dignity, it potentially diminishes public trust in the clinical research enterprise.”
For the study, the researchers recruited patients for mock enrollment in a hypothetical trial in order to examine the effect of a 12-minute computerized slideshow, which emphasized the distinctions between clinical research and clinical care.
According to Christopher, participants who viewed the education intervention showed a substantial reduction in therapeutic misconception compared to those who received the standard informed consent procedure.
“At the same time, receiving the additional educational intervention did not significantly deter participants from wanting to enroll,” he explained.
The educational intervention is brief and can be incorporated into existing informed consent practices as it is currently designed, Christopher said, adding that the next step will be to test the intervention in real world clinical trials.
Source: PLOS ONE
Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials
Authors: Christopher PP, Appelbaum PS, Truong D, Albert K, Maranda L, Lidz C