Here’s how to keep clinical trial participants honest (and why that’s a big deal)

NEJMAdditional lab tests, creating a clinical trial patient registry, and rewards for honesty are among the advice doled out in this week’s issue of the New England Journal of Medicine for researchers to help avoid the major issue of participants lying to get into clinical trials.

In the Perspective, David B. Resnik and David J. McCann, both based at the National Institutes of Health, address concerns raised by a 2013 survey of clinical trial participants that revealed “high rates” of “deceptive behavior.” Specifically:

Three quarters of subjects reported concealing some health information from researchers in their lifetime to avoid exclusion from enrollment in a study. Health problems were concealed by 32% of the sample, use of prescribed medications by 28%, and recreational drug use by 20% of the sample. One quarter of subjects reported exaggerating symptoms in order to qualify for a study and 14% reported pretending to have a health condition in order to qualify.

This is a major problem, say Resnik and McCann, which can have a significant impact on the results of clinical trials. It also puts participants at risk, such as when a woman died of cardiac arrest in a 1980 study after not disclosing a history of relevant conditions. They have outlined several strategies to address the issue.

For instance, researchers can order additional tests to verify information, exclude people who lie during screening, or offer rewards for honest behavior:

Improvements in the accuracy of self-reported data can be expected if researchers inform participants that the accuracy of their information may be checked and that they will receive rewards (e.g., cash or gift vouchers) if, and only if, no discrepancy is detected. For example, plasma samples taken during screening could be assayed for the presence of nonstudy medications, and rewards could be contingent on the detection of no unreported medications.

Finally, they suggest a national registry of clinical trial participants to let researchers ensure participants aren’t double-enrolling in trials, and have allowed a proper “wash-out” period since their last trial.

A few companies, such as Verified Clinical Trials, ClinicalRSVP, CTSdatabase, and DupCheck, now offer clinical trial registration services. Unfortunately, these registries are underutilized. In addition, they do not communicate with each other, so people can participate in simultaneous studies without detection if the studies use different registries.

Resnik told us the 2013 survey illustrated the important role participants play in ensuring the integrity of clinical trials:

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.  Deception by research participants, which may include lying or withholding information, can undermine the integrity of the study and place participants at risk. It is important for participants to honestly provide investigators with information concerning their medical and social history, symptoms, medication usage, participation in other studies, and other types of information related to study enrollment, data collection, and safety.

Resnik has also published on retractions.

We reached out to Eric Devine, first author of the 2013 paper cited by this perspective. He told us that some studies should be approached more cautiously than others:

Drs. Resnick and McCann provide an important perspective on the risk of enrolling professional subject and some of the strategies that could be implemented to reduce this risk.  Strategies should be used judiciously so as to not increase the burden of research to both subjects and investigators without a reasonable expectation of benefit to the study design.

Studies with a very low vulnerability to deception (e.g., medication trial conducted within clinical care with a population that has a well-documented disease history and minimal reimbursement) may not need strong protections against subject deception.  In contrast, when conducting studies with a high vulnerability to deception (e.g., medication trials conducted outside of clinical care where the disease history is not known, there is no objective measure to confirm the diagnosis of the disease, and high levels of reimbursement are provided) researchers should deploy as many protections against deception as can be feasibly implemented.  For these studies with the greatest vulnerability to deception, efforts to protect against subject fraud should include both the systemic remedies (e.g., clinical trial registries) and the localized remedies (e.g., objective testing) that Resnick and McCann suggest.

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One thought on “Here’s how to keep clinical trial participants honest (and why that’s a big deal)”

  1. In my experience at an academic medical center, the patients who conceal information to get into trials are not professional subjects. Rather they are the most educated patients (sometimes medical professionals) who want access to a promising experimental drug or treatment. They want the drug, they have exhausted other treatments, they think the drug will benefit them. If they have to revise their medical history to get in, they will.

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