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3 Questions on...The Problem With Clinical Trial Enrollment: With PAUL SABBATINI, MD, Deputy Physician-in-Chief for Clinical Research at Memorial Sloan Kettering Cancer Center

DiGiulio, Sarah

doi: 10.1097/01.COT.0000489524.18755.e1
Opinion
Free
Paul Sabbatini, MD

Paul Sabbatini, MD

The medical and research community knows that clinical trial patient enrollment is low, explained Deputy Physician-in-Chief for Clinical Research at Memorial Sloan Kettering Cancer Center (MSKCC), New York, Paul Sabbatini, MD. For adult cancer patients, the enrollment rate is just 3 percent, according to the Institute of Medicine's 2010 “Transforming Clinical Research in the United States.”

That's a problem, Sabbatini said. “Every advance in the way we approach cancer treatment today has come from a past clinical trial—and tomorrow's advances will be generated by today's clinical trials.”

To better understand some of the dynamics behind those low clinical trial enrollment rates, MSKCC commissioned a national survey of consumers, as well as practicing physicians late last year. The survey data included 1,511 consumers 18 to 69 and 694 practicing physicians who had previously discussed clinical trials with patients across the specialties of oncology/hematology, obstetrics/gynecology, urology, ear/nose/throat medicine, neurology, pulmonology, or dermatology. MaPS/Millward Brown Analytics conducted the survey; Sabbatini and his colleagues have submitted an abstract with the data for publication.

Sabbatini walked through the key findings from those data (available online: www.mskcc.org) and the implications for oncology in an interview with Oncology Times.

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1 What would you say were the key findings from this survey and were they surprising?

“One of the most significant things we learned through the survey was that only 40 percent of American consumers have a positive overall impression of clinical trials, and only 35 percent are likely to enroll. This was extremely alarming to us.

“Yet after reading a brief statement that helped them to better understand clinical trials, positive impressions among consumers increased to 60 percent. Their likelihood to enroll increased to 44 percent. This points to a desire for education, which is both an opportunity and a challenge that we must embrace.

“Additionally, when we asked about top barriers for clinical trial participation, we found that consumers and physicians share similar concerns. When asked about their main deterrents when considering participating in a clinical trial for cancer treatment, consumers surveyed pointed to side effects/safety (55%), potential costs (50%), location of treatment (48%), and worries over getting a placebo (46%). When physicians were asked what they believe are their patients' biggest concerns when considering participation in a clinical trial for cancer treatment, they cited side effects/safety (63%) and concern about getting a placebo (63%).

“Finally, of the almost 600 physicians polled, more than half (56%) of physicians said they considered clinical trials late in treatment, with 28 percent noting them ‘as a treatment of last resort.’ Only one-third (32%) said they discuss the topic with their patients at the beginning of treatment. However, it is important to evaluate clinical trial enrollment every time a change in treatment is considered.”

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2 How do these results inform how to actually increase clinical trial participation?

“The survey findings signal to us that we must do a better job educating people on what clinical trials are and what they are not—this includes consumers and physicians.

“We also need to be communicating about the importance of clinical trials of all kinds, but especially with cancer. Thanks to the many advances in precision medicine, researchers are now able to sequence more and more genes and to do it at a faster rate. But we must start by having the necessary volume, and that comes from patients feeling they are armed with the information they need to opt in to a clinical trial.”

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3 What would you say is the bottom line that practicing oncologists everywhere—whether they are involved in clinical trials research or not—need to know about these findings?

“Education is our biggest barrier to enrollment. We were pleased to see that when we shared some basic information about what trials are, the overall positive impression of consumers jumped from 40 percent to 60 percent. Physicians also reviewed the statement and the majority responded in a positive way, noting that this type of statement could be helpful/useful—68 percent said they would be likely to use the statement with patients and 69 percent felt it would be effective in educating patients.

“We need to commit to starting a national dialogue on the importance of clinical trials. A collective, collaborative voice is the best way to ensure that the message is being heard.”

Sarah DiGiulio is a contributing writer.

Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.
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