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Is there really a shortage of study volunteers?

Saturday, August 1, 2015

Patient recruitment remains one of the biggest challenges facing the clinical research enterprise today. Forward-thinking industry leaders recognize the need for rethinking the common view that pa­tient recruitment is difficult primarily due to a shortage of study volunteers. Instead, these experts believe the industry needs to focus the discussion on practices that limit access to clinical trials and how to build support sys­tems needed to better engage patient commu­nities and the public in clinical research.

Ever since the National Cancer Institute (NCI) presented data during a 2009 Institute of Medicine (IOM) workshop indicating that only 3% of adult cancer patients participate in clinical trials, many conference speakers and authors have pointed to the statistic as proof that clinical trial volunteers don’t exist and the industry has a crisis on its hands.

The NCI statistic has been misinterpreted. Many stakeholders throughout the clinical re­search enterprise cite the statistic as proof that patient recruitment is an external threat that can’t be controlled.

A recent study from the nonprofit Center for Information & Study on Clinical Research Participation (CISCRP), however, suggests that there isn’t a shortage of patients willing to participate in clinical research. An over­whelming majority (87%) of the public reports a willingness to participate if research made sense for them.

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“There isn’t a shortage of patients; it’s just finding the pathway for them to participate. How do we take that energy or interest and turn it into actual people participating in tri­als?” said Gretchen Goller, senior director of patient access and retention services at PRA In­ternational. “Ultimately, the issue is lack of ac­cess. It’s a lack of education about the benefits of clinical research, a lack of access to finding out about trials and a clear pathway to get patients into those trials. There are all types of obstacles in that pathway linking patients to trials.”

“Our enterprise really needs to think about it in a different light. We have to think about it more as an implementation challenge that requires building all of the necessary pieces that can help raise awareness, ensure easier access and establish a higher foundation of understanding, trust and literacy,” said Ken Getz, director of sponsored research programs at the Tufts Center for the Study of Drug De­velopment (CSDD) and chairman of CISCRP. “When we think of it as an implementation and health literacy challenge, we see that there are many opportunities that require invest­ment to build infrastructure and support. But reaching and engaging patients is no longer seen as an insurmountable problem.”

Building awareness and trust

The disconnect between the low partici­pation rates and a high degree of willingness among the public to join studies suggests that the industry needs to better raise awareness about clinical research and how to access study opportunities.

“Patients don’t take part in clinical trials because they don’t know about them,” said Paul Evans, vice president and global head of feasibility and enrollment solutions at Parexel. “There are two aspects that we need to focus on. How do we make the case for clinical re­search? It’s a good, positive story that should be told and not hidden. We as an industry should also make it easy for patients to be able to ac­cess clinical trials and get the information that they need. Neither of those things happens at present.”

Grassroots outreach and education efforts implemented by CISCRP and other organiza­tions, along with campaigns run by individual site networks, have begun to raise public per­ceptions about the research enterprise. But costs are too high for a single organization or site to support outreach efforts alone and there is a growing call for a more widespread, shared effort to increase general knowledge and pub­lic perceptions about clinical research.

“We need a hard, heavy-hitting national/global campaign to educate the public about clinical research. We need to give potential patients a better understanding of what we do and why it’s important,” said PRA’s Goller. “It would do a tremendous amount of good for everything that we do in this industry. For patients, healthcare providers, families and caregivers, it would put what we do and why it’s important in a whole different light.”

Drug sponsors and CROs spend a great deal of energy on patient recruitment advertis­ing, yet these campaigns will continue to have limited impact until the clinical research en­terprise raises fundamental knowledge about clinical research and trust in the industry among both prospective volunteers and the general public.

“At the moment, we tend to push clinical trials toward the patients we identify. What we need to encourage is more of a pull-approach where patients want to take part in clinical tri­als because they understand the benefits and the opportunities they present to them. That change of mindset would benefit the industry greatly,” said Parexel’s Evans.

Getting health providers on board

Sponsors and CROs have a range of tools and technologies that can be used to make clinical trials more convenient and identify those who would most benefit from clinical research. Underlying these approaches, how­ever, is the need to improve access and support by engaging physicians and other healthcare providers as partners—both to help spread the word as educators and also to help patients and their families navigate the research system when a trial is appropriate for them. Although CISCRP found that more than half of survey respondents would be most receptive to hear­ing about clinical research when the informa­tion came from their primary physicians, only 20% of the public learns about studies from their healthcare providers.

“Not even all physicians understand the dynamics and the process of how research is done. Yet they are the biggest source of refer­rals and patients trust them,” said Mohammad Millwala, chief executive officer of DM Clini­cal Research, a Texas-based site network that won an innovation award last year from the Society for Clinical Research Sites (SCRS) for a pediatric vaccine study recruitment campaign that helped raise education levels about clinical research in the community. “Throughout the entire healthcare ecosystem, awareness about research—particularly among physicians—needs to go up.”

The Florida-based Atlantic Clinical Re­search Collaborative (ACRC), which operates a network of research divisions that conduct clinical trials in different therapeutic areas, has based its business model on building direct re­lationships between its research team and phy­sicians in the community who are committed to supporting clinical trials as a care option for their patients. Network physicians are kept up-to-date about local study opportunities, including inclusion/exclusion criteria for the protocol; identify appropriate patients in their practices for specific trials; prescreen potential study volunteers; and help connect them to the dedicated research site.

“It’s taken us a number of years to develop this infrastructure. The key is engaging with our network physicians and building aware­ness in the community that quality research is going on. Recruitment becomes easier once that is established,” said Debra Weinstein, M.D., chief medical officer and lead principal investigator, ACRC. “The involvement with the doctors not only helps with recruitment, but also with retention. The patients feel that it’s all part of their care.”

The need to develop stronger referral bases with physicians is particularly acute in mi­nority communities. While the proportion of minorities in clinical research remains low, a peer-reviewed study published in PLOS Medicine found a higher willingness among minority patients to participate in clinical research than white patients (48% compared to 42%). Yet minority patients lack access to clinical trials because a dispropor­tionately low number of minority physicians participate in clinical research. Tufts CSDD also has found that minority physicians are less likely to refer their patients into clinical studies than white doctors.

“The industry should be focusing on mi­nority participation,” said PRA’s Goller. “If an African-American patient has a tendency to have an African-American primary care pro­vider, we need to test the limits of what we have been doing and try to expand our network of investigators. We need to try to put ourselves in the place of patients and understand where they get their information.”

When patients don’t learn about clini­cal research from their healthcare providers, CISCRP found almost half (46%) turn to the In­ternet, which can be difficult to navigate when looking for credible, objective, balanced and user-friendly information about clinical trials.

“There are obstacles that are put into place,” said PRA’s Goller. “Unless you have a super-motivated patient seeking information about the trial, we are making it harder for people to reach out.”

Easing participation burden

Some obstacles to patient participation are a direct result of legacy drug-development practices implemented by sponsor companies. Industry veteran John Needham, managing director of Patient Recruitment Strategy, noted that sponsors and CROs often choose investi­gators who have a great deal of experience but lack sufficient numbers of potential study vol­unteers.

Needham added that many protocol de­signs are extremely demanding and complex, making clinical trials unfeasible and inacces­sible for a majority of patients. CISCRP found that among patients willing to participate in clinical research, the top reasons for deciding not to participate included difficulties getting to the research center (23%), too much time re­quired (20%) and an inability to take time away from their job (18%).

“In some cases there are plenty of patients, but there may be so many extra tasks in the protocol that the study is not viable,” said Needham. “We have to make sure the study we offer appeals to patients and doesn’t con­note that we really don’t care about them, that we just want their body for our experiment. We have to stop that [perception], because that is the image that the public and patients have of our industry.”

Needham said it’s often difficult for the industry to rethink patient recruitment chal­lenges because many clinical teams at phar­maceutical companies work in a “cloistered” environment. “Managers involved in study design or protocol development, for example, often have never visited an investigative site, don’t belong to industry organizations or take time for training,” he said.

“They don’t know how unviable their stud­ies are,” said Needham. “How can we rethink patient recruitment when nobody has been trained to really drill down and look at the problems?”

Building bridges

Refocusing the patient-recruitment chal­lenge to address literacy and access speaks to the mission and philosophy of a patient-centered approach designed to engage patients and their communities. Patient advocacy groups have passionate memberships; they are a critical and trusted source for health and clin­ical research information. CISCRP research found that 20% of the public wants to learn about clinical trials through advocacy groups, but only 11% do so through this channel.

Sanofi has created new processes and prac­tices that involve patients and advocacy groups in their R&D processes. The firm has found that patient groups are grateful for the oppor­tunity to talk about their disease with research­ers and to collaborate with a drug sponsor on developing medicines. When Sanofi worked with a patient panel recently for feedback on ways to simplify a protocol, the president of the advocacy association told Sanofi’s team that when the study opened, the entire community would be informed.

“The advocacy groups understand that the community needs to get behind this and par­ticipate in the clinical trials themselves,” said Vicky DiBiaso, head of Sanofi’s Office of Pa­tient Participation & Preferred Partnerships.

Sanofi has moved beyond concentrating on patient-recruitment tactics alone and has cre­ated a more holistic approach that addresses many of the issues around limited access to clinical trials. Sanofi’s model incorporates col­laboration with patients and patient advocacy groups in the development of new medicines from preclinical research through registration. Patients are directly involved in activities across the entire R&D paradigm including early asset identification, study design and outreach. This comprehensive approach improves Sanofi’s ability to build development programs and in­dividual studies around the needs of a patient, so it has the potential to result in faster patient recruitment and overall development timelines.

“In this collaborative environment, patient communities can help with connecting trials to their patient community, and also contrib­ute to a larger sense of trust and joint owner­ship in the development of these potential new medicines,” said DiBiaso.

Sanofi began to develop the new model to incorporate patient insights into R&D discov­ery and clinical development programs in 2011 after it acquired Genzyme.

The company chose to develop the new processes with input from the patient advo­cacy community. An important element was to “lower the barrier” to patient access so that everyone in the organization, including scien­tists and physicians involved in early protocol development, had a quick way to request pa­tient feedback and wouldn’t think it was easier to proceed without it. A Web-based patient engagement portal was created to connect anyone in the organization seeking patient ex­pertise on a project with an internal advocate who could facilitate a meeting with appropri­ate patient representatives.

Anthony Yanni, M.D., global head of Medi­cal Intelligence and Patient Perspectives at Sanofi, said vehicles also have been developed to ensure patient perspectives are made ac­tionable by incorporating learnings and in­sights into project plans and overall strategy throughout the development cycle.

“We think these things are critically impor­tant to create this continuum of patient input into asset development and creating a portfolio that is completely driven to satisfy needs of pa­tients,” said Yanni.

Sanofi Patient Network manager Pat Roselle said the program’s success also has been built on establishing long-term partnerships with patient advocacy groups, which may exist after the clinical development program ends, and exploring mutual benefits to avoid the appear­ance of collaborating with patient advocates and groups only to fulfill recruitment for trials. The company has established a network of pa­tient advocacy group leaders in 60 countries.

“The key to any partnership starts with relationship-building. It’s not only establishing relationships with our patient advocacy com­munities but also how we keep them sustain­able. True to any relationship is establishing trust—we build trust between ourselves and the partner group,” said Roselle.

Early metrics demonstrate that Sanofi’s ap­proach has contributed to improving R&D efficiencies. According to an international industry benchmarking survey, which com­pared the median duration of patient-enroll­ment periods for 23 companies, Sanofi’s rank­ing improved by six points from 2012 to 2013, moving from the 18th position to 12th; metrics from 2015 show the trend continues to move in the right direction. In addition, costly protocol amendments, which often are the result of an inability to recruit a study, have been cut by more than one-half as a result of patient feed­back about ways to reduce study burdens.

“We have a significantly large patient popu­lation waiting for us to come forward with medications. At the same time, we are under pressure to do things faster. We all have the same goals in mind,” said DiBiaso. “By giving patients a seat at the table from the very begin­ning, they can help us improve things such as our study design and how we communicate with the patient community. If we are doing it together, we are all pushing the momentum forward in a much more efficient manner.”

Looking ahead

There is a widespread belief throughout the clinical research enterprise that there is a critical shortage of study volunteers. Yet this emphasis on the lack of participants has been misplaced. CISCRP data shows the public has a high general willingness to participate in clinical research, yet access to clinical trial op­portunities often is limited.

Gaining insight into factors that limit access to clinical trials and make it difficult for pa­tients to participate gives sponsors and CROs the opportunity to modify practices and ulti­mately improve participation rates. There are many opportunities to improve support sys­tems and better engage patient communities and the public in research.

“I don’t think there is a silver bullet when it comes to patient recruitment,” said Evans. “Successful patient recruitment is about doing a large number of small things very well. I’m not sure there is any one thing that is going to transform it. But there is no question that there is a lot we can do to improve it.”

 

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 Masterof Science degree from the Columbia University Graduate School of Journalism.Email karyn.korieth@centerwatch.com.

This article was reprinted from Volume 22, Issue 08, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. Subscribe >>

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