MS Speaks

Patients Wary When Docs Recruit for MS Trials

Majority said they'd trust their physician less if compensated for enrollment

by Kristina Fiore
Associate Editor, MedPage Today

Some 61% of MS patients who'd never participated in a clinical trial said they'd trust their doctor less if he or she was financially compensated for trial enrollment, Eran Klein, MD, PhD, of Oregon Health and Science University, and colleagues reported online in Multiple Sclerosis and Related Disorders.

But trust was better among those who had actually participated in a trial, with only 38% saying their confidence in their doctor would diminish.

"The biggest takeaway for me is that patients, even though they know and trust their physician, have some wariness about other relationships we have and what we bring to the table when we do this," said John Corboy, MD, of the University of Colorado, who was a co-author of the paper.

"Our original paper makes a strong argument that there should be disclosure to patients, especially as it relates to entry in a clinical trial," Corboy told MedPage Today.

Klein agreed that physicians "who are treating MS patients and conducting research should strive for transparency around potential conflicts of interest when enrolling patients in trials" -- particularly during the consent process by disclosing "in unambiguous language, the nature of their financial relationships with funders of research."

The rapid growth in the field of MS ... research and development over the last decade has led to a new role for MS physicians -- as compensated recruiters for clinical trials. That trend isn't expected to decline any time soon, as the MS therapy market is expected to hit a value of $16 billion this year.

"While this may push forward science, it may also raise concerns about physician conflict of interest," Klein said. "If physicians are receiving money for enrolling their patients in studies, could this undermine patients' trust in physicians?"
Stephen Krieger, MD, an MS physician at Mount Sinai in New York, who wasn't involved in the study, said it's "understandable that a patient could be skeptical of a clinician's motivations to enroll them in a trial if physician compensation is involved, because they could feel that their 'best interests' are not the primary motivator."

To explore patients' ideas about these issues, Klein and colleagues conducted an online survey of 597 MS patients, obtaining 552 completed surveys.

From this dataset, Klein and colleagues had previously reported that the majority of patients wanted to know about their doctors' financial relationships with industry.

In the present study, they found that 61% of the patients who'd never been in a trial -- 76% said they never participated and 11% weren't sure if they had -- said their trust would be impacted, which was far higher than the 38% of those who'd previously been involved in a trial.

They said it's not clear if these feelings result from a bias in who participates in research: perhaps those who participate are less concerned about financial relationships in general, or they may develop less concern about these relationships after participating.

Other physician-industry relationships, such as consulting and speaking, adversely affected trust -- but to a lesser extent.

Among those never enrolled in trials, 33% had negative feelings about their doctor speaking for drug companies and 42% disapproved of consulting. The numbers were similar for those who had been in trials: 31% didn't like their doctors collecting speaking fees and 28% disagreed with consulting.

Krieger said the findings raise two areas of concern, one of which is the well-described [misconception] where patients believe enrolling in a trial will benefit them directly.

"This is in fact often not the case, and indeed enrolling in a clinical trial typically is done to benefit science, with no guarantee that the patient will benefit directly – particularly in studies that are placebo controlled, or testing an unproved treatment," Krieger said. "Patients must understand this, and we must take the responsibility to explain it."

The other concern is that patients may not understand how costly it is to run a trial, he said.

"This is an enormously expensive undertaking, and all of the time spent by clinician-investigators, clinical research coordinators, technicians and staff has to be paid for in order to make clinical trials possible," he said. "So it is certainly unfortunate and concerning if this leads to mistrust, and I think the way to address this is by ensuring we communicate thoroughly, transparently, and openly with our patients about these issues."

Klein and Corboy agreed that greater transparency would be an ideal solution.

"It is crucial for our field that MS trials continue and successfully enroll," Krieger said, "and it is crucial for us as physicians to ensure our patients trust our care and our commitment to improving our ability to treat this disease.

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Some of the authors have financial relationships with industry.