Non-Compliant Behavior in Clinical Trials

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Childhood Obesity News has been looking at the question of NCB, or non-compliant behavior, searching for hints as to why youngsters in an obesity study might fudge their reports and sabotage the program that exists only to help them. The literature on that particular problem is scant, but giving some attention to work that has been done in various arenas might help increase understanding. (We already talked about one situation, where patients with chronic conditions fail to follow “doctor’s orders.”)

A clinical trial, according to the World Health Organization, is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” The definition from the National Institutes of Health adds a couple of details. Intervention might include no intervention, or a placebo, and they more expansively speak of “health-related biomedical or behavioral outcomes.”

Big Pharma’s role

The type of clinical trial with a narrow focus is found throughout the pharmaceutical industry. The company wants to know the specifics of a certain compound. First, is this depression medicine safe, or does it make people’s blood pressure go up? Second, does it seem to work, to alleviate depression, on a small sample of people? If so, then with approval it enters the third stage, randomized and blind testing on hundreds or thousands of patients.

In the first stage, a clinical trial generally pays healthy volunteers to put aside their ordinary lives for a while. The researchers need to track every detail of how the substance is absorbed, metabolized, and excreted. Aside from its intended purpose, what else does it do? What happens when the dosage is increased? It is easy to understand why corporations build their own dorm-like facilities and require study participants to remain under surveillance for the length of the trial.

Many purposes of clinical trials

Inpatient trials are not necessarily limited to pharmaceutical research, and when outpatients are involved, the range of possible applications is vastly wider. In this scenario, treatment and research are dual goals. Science will be advanced, and the patient will benefit.

The trials of Dr. Pretlow’s W8Loss2Go weight loss intervention, for instance, were designed to both help and learn. So in that type of situation, a subject who “cheats” in any way does two different types of harm — to the research effort, and to the self.

Jim Lane writes:

Protocol non-compliance at clinical research sites is a well-recognized problem… A proliferation of protocol deviations can fatally undermine study results, thereby nullifying years of effort and dedication.

NCB breaks the integrity of the research. It produces skewed outcomes that have to be thrown out. A clinical trial is a resource-intensive endeavor, so one consequence is the waste of funds that could have been usefully spent elsewhere. Also, the patient could lose out on whatever benefits might have occurred as the result of close adherence to the program.

When a drug is involved, this can be downright hazardous. Skipping a dose might cancel out the efficacy entirely; double-dosing could be toxic. In clinical trials of investigational medical products, research has found that, by 150 days in, approximately 40% of patients had strayed from compliance in some way.

This brings up a side question. Lane writes:

Sponsors spend a lot of time, effort, and money finding deviations, implementing corrective and preventive actions, and cleaning data. The combined cost of CRA resources [number-crunching Clinical Research Associates], sophisticated centralized analytics, and data clean-up activities can be enormous.

What if people started to be totally forthcoming when, for instance, filling out self-reportage questionnaires for research purposes? How would that translate into what one company elegantly terms the “increased reliability of the endpoint data”?

To account for a predictable number of cheaters, exceptions are already built into the algorithms. Would honesty just mess everything up?

Your responses and feedback are welcome!

Source: “Can Patient Engagement Improve Protocol Compliance?,” Longboat.com, 02/21/17
Source: “Non-Adherence: A Direct Influence on Clinical Trial Duration and Cost,” AppliedClinicalTrialsOnline.com, 04/24/17
Source: “Patient & Protocol Compliance In Clinical Trials,” ClinicalLeader.com, 03/30/15
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