In the largest and most in-depth global survey of its kind, the Center for Information and Study on Clinical Research Participation (CISCRP) found the public has a high level of willingness to participate in clinical research, yet the industry lacks the ability to translate that support into clinical trial participation.
In addition, the disconnect between the stated willingness to participate in clinical research and low participation rates was more pronounced in certain subgroups, including minority communities and patients with mild-to-moderate diseases.
“The results are sobering,” said Jeffrey Kasher, Ph.D., president of Patients Can’t Wait, a consultancy he began last year after 28 years of leadership experience at Eli Lilly. “It raises some very big questions for the industry about how we are going to move the needle and increase participation in trials. What do we need to do?”
In general, the public has a good conceptual sense about why clinical research is important for the development of new medicines, yet the study found that individuals lack a personal connection to research and its significance in advancing public health. In addition, the data show that potential clinical study participants don’t have suitable access to clinical trial opportunities—largely due to a lack of encouragement or support from their physicians and other healthcare providers, who are typically unaware of studies that might benefit their patients.
“Patients just are not asked or aware. Either they are never approached by their most trusted source—their primary care physicians or treating physicians—or they don’t know how to find the information,” said Beth Harper, president of Clinical Performance Partners, a clinical research consulting firm specializing in enrollment and site performance management. “If they don’t have a general need or health issue, they are probably not searching and trying to get educated about clinical trials. But when they do have a need, they just may not have much accessible information.”
The new study offers valuable baseline and trend data to understand patient perceptions and attitudes about clinical research, as well as insights into new opportunities for engaging study volunteers in a more effective manner.
“Patient enrollment still tends to be a top obstacle,” said Scott Connor, vice president of marketing at Acurian, a subsidiary of PPD. “Without understanding what people are thinking and perceiving about clinical trials, and taking the pulse every couple of years, we are all kind of fighting an enigma.”
Largest poll of patient attitudes
CISCRP’s 2015 Perceptions & Insights Study, which builds on its 2013 survey of public and patient attitudes about clinical research, was based on responses from more than 12,000 participants, including some 3,000 study volunteers, from 92 countries. Compared to the 2013 study, the participation rate in 2015 more than doubled and there was a greater proportion of respondents from outside of the U.S. The survey was distributed online between April and May with support from Acurian, Clariness, Quintiles and PMG Research.
The large sample size allowed CISCRP to look at public and patient attitudes, perceptions and experiences both overall and by subgroup, including race and ethnicity, severity of disease, age, education level and geographic region. For this story—given the scope of the CISCRP study—The CenterWatch Monthly will focus on notable differences in the ethnicity/race and severity of disease subgroups; future stories will address findings from other categories.
A lack of ownership for success of clinical research
The general public has a strong conceptual sense about the importance of clinical research, with 99% of respondents acknowledging its importance to the discovery and development of new medicines.
Overall, public ratings of their general knowledge about clinical research didn’t change from the 2013 survey, with 81% of respondents saying they had some level of understanding about clinical research. Yet genuine knowledge may be more elusive. Only 25% of the general public said they were “very informed” about clinical trials; significantly, 45% of respondents who indicated they were “very informed” had previously participated in a study. In addition, more than half (58%) of respondents stated they rarely or never considered clinical research when discussing healthcare options with their doctors.
“There is still an educational gap regarding what it means to participate in a clinical trial. People don’t really get that information unless they do a lot of research or they are asked to be in a clinical trial. Then they understand,” said Jim Kremidas, executive director at the Association of Clinical Research Professionals (ACRP), who also has more than 30 years of experience leading patient recruitment and retention programs at Quintiles, Eli Lilly and other organizations. “To this point about why [there is] such a high willingness and low participation, there are two factors: One is a lack of really understanding what it means to be in a clinical trial. But maybe more importantly, they are not frequently asked to be in a clinical trial, so there is a low level of awareness that they could participate if they wanted to.”
More than half of respondents indicated they understand some of the theoretical benefits of clinical research, including getting access to the best doctors (54%), the best possible treatment (59%) and a chance to receive free medicines and care (68%). Yet at the same time, 35% of respondents said clinical trial volunteers are gambling with their health—an increase from 29% in 2013—and 10% believes clinical trials are unsafe.
The study findings suggest an educational opportunity to draw a stronger connection between public health and clinical trials, which can help create a higher sense of ownership among individuals for the success of clinical trials, and the need to build greater trust in the clinical research enterprise.
“Part of improving recruitment and engagement is to educate the populace about the research process. We need to show people, especially when they are young, how the scientific method applies not only to how we design experiments in chemistry or biology, but also how we develop and test new therapies and treatments for human beings,” said Jamie Roberts, senior clinical project manager at the Clinical Trials Transformation Initiative (CTTI), who leads a project working to identify barriers and potential solutions to clinical trial recruitment. “We are all benefiting from this research every day. What can we do on a personal level to give back?”
Improving access to clinical trials
While sponsors, CROs and sites increasingly adopt lower-cost, high-reach technology solutions to improve patient recruitment and retention, the CISCRP study found that patients still prefer a more personal approach when making the decision to participate in a clinical trial. Respondents said they received most of their information about clinical research from television or newspaper advertisements (33%), social media (22%), online government registries (21%) and pharmaceutical company websites (15%).
Still, 51% of prospective study volunteers said they want to learn about clinical research studies from their primary care or specialty care physicians, and an even greater majority of patients (71%) said they wanted to consult their own physicians when making a decision about clinical trial participation. Despite those desires, survey results show only 23% of patients end up learning about clinical research opportunities from their doctors and just 17% of patients ask their doctors about study opportunities they may have discovered on their own.
“How do people find out about trials? They want to find out from their physicians, but they don’t. Physicians don’t have the time to stay up on trials. So if you can’t find out about trials from the most trusted source, your chance of going into trials is lower. We need to do a better job of educating physicians about clinical research,” said Kasher.
Ken Getz, founder and board chair of CISCRP and director of sponsored research programs and associate professor at the Tufts Center for the Study of Drug Development (CSDD), said if the industry truly wants to build a system that supports clinical trial participation, it needs to find better ways to engage the people who patients want and expect to help them learn about clinical study opportunities and manage the research process. For healthcare professionals, which is the community that patients most trust, the enterprise needs to create a higher level of awareness about clinical research and to provide tools that allow them access to credible information about studies more easily.
“It’s getting to that disconnect between the patient turning to their primary care and specialty care physician and expecting them to be more aware and actively engaged. Many patients are not finding that,” said Getz.
“For the prospective volunteer, we have failed to create a support network that can help them navigate the overwhelming challenge of trying to make sense out of clinical research and whether it is important for them personally. The only way our outreach to the patient community can be effective is if there is a safety net—a system of support that is already in place to help them,” Getz added.
While there is widespread agreement that the industry needs to increase efforts to better educate physicians and professional communities about clinical research, and several initiatives have been formed to address that area, the efforts haven’t yet made a big impact.
“While we are doing better at building public awareness, the overall pool of researchers is declining and there is no incentive for physicians to get involved in research,” said Harper. “Primary-care treating physicians—who are the best source to recognize whether a patient might qualify—are not exposed to clinical trial options. This is where a lot of work and effort needs to go and it has not been tackled in a systematic fashion. A lot of people talk about it in broad strokes, but we don’t have an initiative around gaining more participation in clinical research by the actual practitioner.”
Notable subgroup findings
Many clinical trials target mild or moderate diseases. Yet patients with mild diseases view clinical research in a different way than those with more severe diseases, according to important subgroup findings, and can be more difficult to engage in clinical research. Those with mild diseases have a more limited personal connection to research than patients with more severe conditions; respondents with mild diseases rated their general knowledge about clinical research 15 percentage points lower than those with very serious illnesses and were less likely to believe that study volunteers make an important contribution to science.
In addition, the healthcare provider community isn’t as sensitized to clinical research as an option for such patients, so those with mild diseases have to do more self-advocating when they want to join a trial, according to the study. While 40% of respondents with very serious diseases learned about clinical trial opportunities from their primary care physicians, only 32% of those with mild conditions learned about studies from that same source. Patients with mild conditions, who typically lack a support network that could guide them toward research opportunities, showed lower levels of being “very confident” about finding an appropriate research study compared to those with the most severe disease.
“Each patient matters and each patient is basically telling us they would like to know what clinical trial options are out there. But if their doctor is only recommending trials to the most seriously ill, then clearly that is a different expectation,” said Getz. “Engagement is not a standard set of activities but, in fact, it has to be customized. There are so many factors we have to weigh in order to identify the right message and opportunity for each patient.”
Patients with mild or moderate conditions also indicated they are less eager to get involved with clinical research than those with severe illnesses. Only 55% of patients with mild conditions expressed that they would be “very willing” to participate in a research study, compared to 75% of those who are severely ill. Those with very mild conditions, which they can likely manage with existing therapies, also were more likely to believe they were taking a gamble with their health when participating in a clinical trial (31%), compared to those with very severe illness (22%).
Mark Lacy, president and CEO of Benchmark Research, said messaging strategies for patients with mild-to-moderate diseases could focus on the fact that clinical trials test potential new medicines that treat their condition better than current therapies and that patients could be paid for their participation. In addition, study volunteers typically receive a great deal of face-to-face time with doctors and medical staff in clinical trials, and study sponsors often pay for special tests the patients wouldn’t otherwise receive.
“You expose them to the fact that there are clinical trials out there that may treat their condition better and it compensates them better. They are paid to be altruistic,” said Lacy. “It’s basically educating the patient to the fact that they are not just participating in a study for mild-to-moderate conditions, but they are getting a lot of perks they wouldn’t otherwise get.”
In another subgroup finding, contrary to widely held beliefs, the CISCRP study found a high level of willingness among minority communities to participate in clinical trials and that respondents from different ethnic and racial groups generally share positive perceptions about clinical research. Black respondents, in particular, were more likely to rate their general knowledge about clinical trials as “very informed” (38%) versus white respondents (24%) and a higher percentage of black respondents (45%) expressed they were “very willing” to participate in research compared to white respondents (40%).
Yet minority respondents typically rated their level of access to clinical research lower than white respondents or the general public. A lower percentage of black respondents (67%) felt they could speak to their primary care physician about clinical trial opportunities than white respondents (73%), were not confident they could find an appropriate study (21%) and noted that the distance of research sites from their home or work was a very important factor that could prevent them from participating in a study (61%). Respondents from most Hispanic and Latino subgroups also were less likely to have ever tried to participate in a trial than the white respondents.
As is true for the overall population, ethnic and minority patients prefer to receive information about clinical trials from their primary care or specialty care physicians and expect their healthcare providers to be more actively engaged in research, but patients from those subgroups are not getting the information they want from such trusted sources. Other research studies also have shown that minority patients typically seek physicians of their own race or ethnicity, but the percentage of minority doctors who participate in clinical research is low in proportion to the overall community.
Some sponsor companies have undertaken initiatives to increase participation of minority physicians in clinical research. For example, Eli Lilly, which has been a leader in efforts to make research more accessible to minority communities, has formed a partnership with the New York-based Center for Drug Development and Clinical Trials at Roswell Park to train minority physicians and actively recruits investigators with diverse patient populations.
“You have fewer minority investigators and fewer minority physicians. But people tend to go to physicians more like themselves,” said Kasher. “The key is raising awareness among minority physicians and increasing the number of minority investigators.”
A number of other organizations have recognized the opportunity for grassroots efforts to engage patients from minority communities through places like retail establishments, local churches and community centers. Companies also have begun initiatives that include translating materials into culturally appropriate languages and partnering with advocacy organizations to address barriers of engaging minority patients in clinical trials.
Parexel works with the Consortium of Diversity in Clinical Research (CDCR), a group of sites that have minority principal investigators or large databases of minority patients, other research partners and patient advocacy groups to raise awareness about clinical trials and ensure diverse patient populations are included in most studies. Partnership opportunities with patient advocacy groups might include email blasts, print advertisements in group newsletters or magazines, or a study spotlight on the group’s website.
“We understand that minority patients are more than willing to participate in clinical trials. Our job is to ensure that we create the easiest path for our patients to find and participate in our ongoing projects because they understand the benefits and opportunities they present,” said Almenia Garvey, associate director of site alliances at Parexel.
The CISCRP study offers opportunities for improving public outreach and education efforts, and for building support systems needed for potential study volunteers to become involved in clinical research trials. The study also offers unique insights into attitudes of patients from different subgroups, which can be used to target those communities with tailored messages and educational initiatives.
Moving forward, the industry will need to monitor changing attitudes and experiences among the public and subgroups as it implements initiatives that can help improve patient engagement and partnerships in clinical research.
“All of it comes down to: How do you engage people with messages and information that really resonates with them and are relevant to them? You do it by actually engaging them in the process. The whole goal is to improve patients’ ability to engage in evidence-based, shared decision-making with their provider,” said Roberts. “And the providers have to be engaged too.”
Karyn Korieth has been covering the clinical trials industry for CenterWatch since 2003. Her 30-year journalism career includes work in local news, the healthcare industry and national magazines. Karyn holds a Master’s of Science degree from the Columbia University Graduate School of Journalism. Email email@example.com.
This article was reprinted from Volume 23, Issue 01, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>