Lies and Desperation: How, Why ‘Professional Study Subjects’ Skew Clinical Research

This article was first published on Medspace

July 14, 2020

By Damian McNamara

Weingard agrees, noting that side effects, serious adverse events, and even deaths have occurred in study subjects participating in multiple clinical trials. This makes it impossible to determine whether such events are caused by a specific single agent or a drug interaction.

Professional subjects can also skew trial results by reporting exemplary compliance while not actually taking the treatment at all. “Your ability to separate active treatment from placebo is diminished,” Shiovitz says.

“Pandora’s Box” on the Horizon

David McCann, PhD, and colleagues from the National Institute on Drug Abuse, describe another kind of subject, one they call “destined to succeed.” Such individuals pretend to have a condition, enroll in a trial, and report symptoms that quickly resolve.

Remission, they find, is easier to fabricate than disease. Such behavior, McCann notes, can substantially increase the statistical placebo response rate, while decreasing the size of an observed effect.

A growing body of literature suggests 30% of professional study subjects do not take the study drug according to protocol, Paley notes. People who over-report adherence skew the data researchers collect during a study, she says.

When the investigators look at the results, they can misinterpret the effect of a particular drug and put future patients as risk. In addition, such false results can and have caused drug trials to fail, in some cases preventing a potentially useful drug from gaining approval and reaching the market.

“These subjects intentionally over-report adherence,” Paley says. “Not only does this interfere with the integrity of the data but it may lead to incorrect interpretation of trial results, placing future patients at risk.”

Or, she says, it could cause trial to fail, preventing progress of what might otherwise have been a potentially successful drug.

Even once all these problems have been addressed, Weingard sees another potential danger on the horizon — online trial enrollment.

“We’re going to see a huge shift to virtual trials within the next 2 to 3 years. The doctor will interact with the participant on video, and everything for the trial will be shipped to the home.”

When this happens, she says, individuals won’t have to present at research sites. Doing everything virtually, Weingard says, “will open a ‘Pandora’s Box’ if steps are not taken to prevent or minimize enrollment in multiple trials.”