The publicity around the current COVID vaccine clinical trials has done much to make the public aware of the difficulties researchers face to ensure the safety and effectiveness of the therapy being tested.
Besides the now well-known need to recruit participants representing all age groups, races, and other demographics, clinical trial managers also have to be on the lookout to avoid what the pharma community has come to call “professional study subjects.”
These individuals are so eager to participate in a clinical study they lie about their medical condition, misrepresent their lifestyle, fail to disclose medications they take and may participate in more than one, even several studies simultaneously.
Eric Devine, PhD, assistant professor of psychiatry at Boston University School of Medicine, says, “I was doing clinical trials and I was running into people who were just lying to me. It was blatant when I looked at their medical records.”
Money is what motivates most professional study subjects, according to a Medscape report. Many trials pay participants, enabling some to earn thousands of dollars. One man who entered an Alzheimer’s trial legitimately earned $31,000.
Others may be driven to participate because of free medical treatment. The Medscape report mentions one woman who lied to get into a trial involving botulinum toxin. “I wanted to get into the study. I wanted free Botox, so I participated. And I got paid — so why wouldn’t I?”
A study of the problem published in 2013 found 75% of the subjects who had participated in at least two trials in the previous year admitted concealing some important medical information:
- 32% hid health problems
- 28% concealed their use of prescribed medications
- 20% failed to disclose their recreational drug use
- 14% reported pretending to have a health condition in order to qualify.
Even when these professional study subjects have more altruistic motives, their deception can skew trial results. If enough of these types of study subjects manage to enroll – and the estimate is that as many as 25% of volunteers apply in a way that violates trial criteria – the results can be skewed.
Medscape says misrepresentation can be serious enough to “invalidate outcomes and even halt further research.”
Subject registries exist to attempt to catch the professional subjects. When detected, these individuals can be entered in a registry. Recently, these registries have begun to incorporate biometric data to foil the professional subjects who have used fake identification.
“That can sound very ‘Big Brother-ish’,” Devine says. “But think about the quality of our information — it can either be lifesaving or not. Do we really want to take a chance with medicine as a science, and leave it up to ‘Well, I hope we didn’t have too many professional subjects in this trial?’ “