Educating People About Clinical Trials May Improve Their Likelihood of Participation

Findings from an MSK survey showcase barriers to clinical trial participation and how to overcome them.


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The facts are well known: Although clinical trials are regarded as the gold standard to investigate whether a new treatment is safe and effective in patients—and have resulted in advances in cancer cures and increases in cancer survivorship—only 3% to 5% of patients enroll in these studies.1 The reasons are well documented and range from patients’ fear of treatment side effects, potential costs involved, and inconvenience to daily life. The consequences of such low patient participation in clinical trials are that oncology drugs take longer to develop than non-oncology drugs2 and contribute to their higher cost.3

To gain a greater understanding of why participation in cancer clinical trials remains so stubbornly low and identify solutions to overcome this trend, this past fall, Memorial Sloan Kettering Cancer Center (MSK) in New York surveyed over 1,500 consumers, aged 18 to 69, and nearly 600 physicians about their perceptions of clinical trials. The physicians surveyed specialized in the fields of oncology/hematology, gynecology, gastroenterology, urology, otolaryngology, neurology, pulmonology, and dermatology. The survey was conducted online between October and November 2015 and offers some enlightening insight into both consumers’ and physicians’ knowledge about the benefits of clinical trials.

Connecting Patient Care With Clinical Trials

Although a huge majority of respondents—94%—said they were aware of clinical trials, only 40% had a positive impression of them, and just 35% reported they would enroll in a clinical study. As in other studies examining these issues, among respondents’ top barriers to trial participation were uncertainties regarding the treatment’s side effects and safety; concerns about insurance coverage and out-of-pocket costs; inconvenient location of the study; the possibility of receiving a placebo; and worry about the hospital’s ability to provide quality care.

One telling finding is that although most respondents—72%—agreed they saw no difference in care with hospitals that offer clinical trials vs those that do not, an even greater number—74%—said having the option of a wide range of clinical trials was important when choosing a hospital specifically for cancer treatment.


The direct relationship between familiarity with a clinical study and willingness to enroll is what surprised me the most from the survey results. The burden is definitely on us to provide the education that allows patients to make informed choices.
— Paul Sabbatini, MD

“People don’t connect ‘patient care’ with clinical trials, but, in fact, most patients enrolled in clinical studies receive frequent testing and are seen by multiple medical providers throughout their participation,” said Paul Sabbatini, MD, Deputy Physician-in-Chief for Clinical Research at MSK.

Physicians as Barriers to Patient Participation

In perhaps one of the most stunning findings in the survey, 56% of physicians said they only consider a clinical trial as an option for their patients late in the course of treatment, and 28% said they consider a clinical trial a “treatment of last resort.” Only 32% said they discuss clinical trials with their patients at the initiation of treatment.

“This is a huge problem,” admitted Dr. Sabbatini. “Often patients arrive at a cancer center after having multiple prior treatment regimens and are no longer eligible for a clinical trial. The question I ask every time I’m considering a treatment change for a patient is, ‘Is there a more rational standard treatment or investigational treatment to offer the patient?’ We want to get patients early enough in their disease course so they have the possibility of benefiting from a therapy. They may still decide not to enroll in a clinical trial, but at least they should have an understanding of what their options are.”

Information Is Key

Another key finding is when consumers were given a brief statement that provided information about clinical trials, including a definition of what a clinical study is and how patients may benefit from participation in one, their overall perception of clinical trials rose from 40% to 60%, and their likelihood of enrolling in a clinical trial jumped from 35% to 44%.

“The direct relationship between familiarity with a clinical study and willingness to enroll is what surprised me the most from the survey results,” said Dr. Sabbatini. “This finding shows that doing just a small amount of patient education about clinical trials and having patients understand what their options are make them more willing to consider enrolling in a study. It is reassuring to learn we have a relatively easy way forward in making some inroads into increasing clinical trial participation. The burden is definitely on us to provide the education that allows patients to make informed choices.”

A limitation of the survey results is that details regarding demographics of the consumers surveyed, including race/ethnicity, income level, and whether they or someone they know had ever had cancer were omitted from the questionnaire. “This was a first attempt to ask a broad question and see what we could find regarding people’s perceptions about clinical trials,” explained Dr. Sabbatini. “We are now discussing the next steps and plans to prospectively collect more detailed information.” ■

Disclosure: Dr. Sabbatini reported no potential conflicts of interest.

References

1. Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation: Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC, National Academies Press (US), 2010.

2. Tufts Center for the Study of Drug Development Impact Report. Oncology drugs get faster approvals than non-oncology drugs in U.S. vol 14, number 5, September/October 2012.

3. Eisenberg C: Drugmakers mine data for trial patients. Bloomberg Businessweek; November 3, 2011. Available at bloomberg.com/news/articles/2011-11-03/drugmakers-mine-data-for-trial-patients. Accessed July 13, 2016.



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