Nudging patients into clinical trials

Bradley J. Fikes in the San Diego Union Tribune: “The modern era’s dramatic advances in medical care relies on more than scientists, doctors and biomedical companies. None of it could come to fruition without patients willing to risk trying experimental therapies to see if they are safe and effective.

More than 220,000 clinical trials are taking place worldwide, with more than 81,000 of them in the United States, according to the federal government’s registry, That poses a huge challenge for recruitment.

Companies are offering a variety of inducements to coax patients into taking part. Some rely on that good old standby, cash. Others remove obstacles. Axovant Sciences, which is preparing to test an Alzheimer’s drug, is offering patients transportation from the ridesharing service Lyft.

In addition, non-cash rewards such as iPads, opt-out enrollment in low-risk trials or even guaranteeing patients they will be informed about the clinical trial results should be considered, say a group of researchers who suggest testing these incentives scientifically.

In an article published Wednesday in Science Translational Medicine, the researchers present a matrix of these options, their benefits, and potential drawbacks. They urge companies to track the outcomes of these incentives to find out what works best.

The goal, the article states, is to “nudge” patients into participating, but not so far as to turn the nudge into a coercive shove. Go to for the article.

For a nudge, the researchers suggest the wording of a consent form could include options such as a choice of preferred appointment times, such as “Yes, morning appointments,” with a number of similarly worded statements. That wording would “imply that enrollment is normative,” or customary, the article stated.

Researchers could go so far as to vary the offers to patients in a single clinical trial and measure which incentives produce the best responses, said Eric M. Van Epps, one of the researchers. In effect, that would provide a clinical trial of clinical trial incentives.

As part of that tracking, companies need to gain insight into why some patients are reluctant to take part, and those reasons vary, said Van Epps, of the Michael J. Crescenz Veterans Affairs Medical Center in Philadelphia.

“Sometimes they’re not made aware of the clinical trials, they might not understand how clinical trials work, they might want more control over their medication regimen or how they’re going to proceed,” Van Epps said.

At other times, patients may be overwhelmed by the volume of paperwork required. Some paperwork is necessary for legal and ethical reasons. Patients must be informed about the trial’s purpose, how it might help them, and what harm might happen. However, it could be possible to simplify the informed consent paperwork to make it more understandable and less intimidating….(More)”