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ost Americans would not enroll in clinical trials over concerns they would experience side effects, encounter higher costs, or receive a placebo instead of an actual medicine, according to a new survey.

Specifically, only 35 percent say they were likely to participate in a study and, overall, just 40 percent have a positive view of clinical trials, according to the survey released on Monday and conducted by the Memorial Sloan Kettering Cancer Center, a leading hospital based in New York that also conducts hundreds of clinical trials.

The results underscore the difficulties that confront policy makers, pharmaceutical companies, and health care providers as they seek to develop and deliver new treatments. And if this sort of reluctance to participate in trials continues, there is concern there will be a research and discovery “crisis,” according to Paul Sabbatini, the deputy physician-in-chief for clinical research at MSK.

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Indeed, clinical trials are the engine that drives innovation. “This is a critical element in the process,” he said. “We have so many new agents and opportunities to improve outcomes. But if we don’t enroll people in clinical trials, we will not realize the benefits.”

But it’s not just the average patient who is uncertain about whether clinical trials are worth the effort. The survey also found that even a majority of physicians — 62 percent, to be exact — are unsure or indifferent about the extent to which participation in a clinical trial will benefit patients. Most doctors also worry that their patients will be concerned with suffering side effects or receiving a placebo.

The survey queried 1,511 consumers between 18 and 69 years old last fall, as well as nearly 600 practicing physicians who reported that they discussed clinical trials with patients. These doctors specialized in oncology, gastroenterology, neurology, pulmonology, and dermatology, among other fields. The survey participants were not drawn from Memorial Sloan Kettering.

Of course, different surveys often yield different results. Three years ago, the Association of Clinical Research Organizations, an industry trade group that represents companies that run trials for drug makers, found that 72 percent of Americans would likely participate in a study if their doctor identified a trial and recommended they enroll.

In any event, Sabbatini said he was encouraged by some of the findings. For instance, 65 percent of those surveyed by MSK believe clinical trials are important. And after they read a brief statement that provided more information about clinical trials and their impact on medicine, positive impressions rose to 60 percent. The likelihood of enrolling also increased — to 44 percent.

“A simple paragraph dispelled some of their concerns,” said Sabbatini.

Here are some other tidbits: worries over side effects were the biggest concern with 55 percent of survey participants citing this is an obstacle. And half are concerned about insurance and out-of-pocket costs, while 48 percent say trial site may be inconvenient. Forty-six percent worry about receiving placebos, and 35 percent were skeptical about whether a medicine would work. And 34 percent do not want to be guinea pigs.

In addition, 42 percent of those surveyed said they would consider participating in a trial for cancer if there were no additional out-of-pocket costs — a concern that is shared by 37 percent of physicians. And 58 percent of doctors felt that if they had a patient considering a clinical trial for cancer, the key reasons to participate would be if a particular treatment is only available through a study, or if the patient had already tried all available standard treatments.

The story has been corrected to say that 35 percent of respondents said they would participate in a clinical trial. Previously, the story said 35 percent said they would not participate. 

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  • The patient pool has drastically shrunk. It was easier to recruit patients when there were 40 million uninsured. People have all kinds of reasons free medical care for one. Also we cannot do competitive enrollment ethically speaking. There was nothing in it for the PI but a winning study nurse could get an all expense paid trip to a scientific meeting. I ran trials for 30 years, and despite patients’ understanding that the drug may not benefit them directly they recognized that it could benefit society at large. Today we live in a “me world”; altruism is dead. But if anyone is earnest about clinical trial participation there is a Phase 4 study ongoing of a new antidepressant called Ablixa. Consult with the Principal Investigator, Dr Law for details.

    http://www.tryablixa.com/

  • There are two issues: awareness and education. All parties involved in research, including sponsors, CROs, researchers, physicians and the government must do a better job of making people aware of clinical trials and educating them about the benefits of participating in trials. One place to start is making clinicaltrials.gov more useful for patients because it is currently an embarrassment. It should be integrated with EHRs also to drive awareness and access. Low participation rates in clinical trials are a major factor why the development process takes so long. We must do better because the current situation is not sustainable and patients should not have to wait so long for new treatments and cures.

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