According to the report, up to 75% of clinical trial participants withheld information to avoid exclusion from studies.
Co-author Dr. Lee Chuen Peng, consultant, Tan Tock Seng Hospital, explained that from the researchers’ recent literature review, the most common form of reported deception was concealment, followed by fabrication, drug holidays, and collusion.
The researchers defined concealment as an intentional non-disclosure of medical information. Fabrication, the act of invention aimed at achieving deception.
Collusion involves sharing privileged information pertaining to clinical trials or sharing trial drugs, and drug holidays are periods of consecutively missed drug doses, Peng explained.
“Deceptive behavior may result in invalidation of studies, causes harm to participants, misleads investigators, [and] squanders precious research resources,” he told us, adding that such practices are prevalent worldwide.
However, across all deception categories, Peng said the researchers noted higher rates in participants who were male, nonwhite, older, pregnant, and of a lower education level.
Participants lacking social support and with a history of drug abuse also had higher rates of deception, as did those who experienced longer intervals between follow-up, did not receive feedback regarding their adherence, and had negative treatment attitudes, he explained.
“Overcoming deception is a critical issue, since the safety of study participants, the integrity of research data and research resources are at risk,” according to the researchers.
To address the challenges of deception in clinical trials, Peng said the use of centralized registries of participants could minimize the incidence of co-enrollment. Electronic devices that monitor and validate drug administration also can reduce adherence misreporting.
Source: Contemporary Clinical Trials , Volume 72 , 146 – 157
Deception in clinical trials and its impact on recruitment and adherence of study participants
Authors: Lee, Chuen Peng et al.