Clinical trial participants sometimes lie about or exaggerate their health issues to gain entry in to studies, but a pair of researchers offers strategies in the New England Journal of Medicine to combat such deception.
"In addition to researchers, participants in clinical trials also have an important role to play in maintaining the integrity of the research and being honest when participating in research efforts," National Institute of Environmental Health Sciences' David Resnik tells Retraction Watch. "Deception by research participants, which may include lying or withholding information, can undermine the integrity of the study and place participants at risk."
A 2013 survey, published in Clinical Trials, reported that three quarters of subjects admitted concealing health information that might have led to them being excluded from the study, while a quarter reported exaggerating symptoms — and a full 14 percent pretended they had a condition they did not — so they'd qualify for the study. Others were participating in multiple trials at once. The survey focused on trials that financially compensated participants.
This, Resnik and National Institute on Drug Abuse's David McCann write in a Perspectives piece at NEJM, can bias the data. For instance, they note that if participants pretending to have a disease are taking part in a trial examining medication efficacy, they could affect the study's statistical power and apparent effect size.
There are a few ways to minimize the inclusion of such deceptive trial participants, Resnik and McCann say. Researchers could use physical exams and laboratory tests to confirm what patients tell them, provide reinforcements for truth-telling — like giving a gift voucher when tests back up the information provided — and require participants to be listed in a clinical trial participant registry.