Clinical Researcher—April 2020 (Volume 34, Issue 4)
MANAGING EDITOR’S MESSAGE
Gary W. Cramer
Recruiting volunteers to do something for which they know they are well qualified and actually have an interest is one thing; recruiting them to do something they don’t know they may be ideal for and have maybe never even heard of is quite another matter.
Such is the common dilemma faced by the professionals whose job it is to find volunteers for clinical trials. Finding subjects for Phase I studies offering remuneration is not such a great challenge in most cases, but finding and educating subjects who are actually affected by the conditions under study for later phases of research presents all sorts of stumbling blocks on the way to “closing the deal” and enrolling them.
While gathering and editing the various articles on patient recruitment and retention topics found elsewhere in this issue, I found myself wondering what some of those complicating factors might look like in the real world and asked a few questions. Here are some of those questions and the answers that presented themselves:
Are there country-specific quirks or challenges to be encountered when recruiting subjects—things new recruiters aren’t necessarily expecting to be an issue that may suddenly crop up as a hurdle to attracting participants in one or a few countries, but not in others? If so, how have recruiters dealt with them?
According to Tricia Barrett, senior vice president and managing director with Praxis, an industry-leading patient recruitment and retention company, “When creating educational and awareness materials for direct-to-patient outreach, it’s not a one size fits all approach in extending globally. Each country has its own unique rules and regulations, and even more important is the cultural adaptation that must take place—whether it’s through imagery, content, tone, or even design.”
Barrett notes that a word or a color can mean one thing in one country and something completely different in another. Further, “A simple language translation is not enough,” she explains. “Transcreation—also known as cultural adaptation—is imperative to a successful global clinical trial. This process ensures that your message is maintained in style, tone, and context.”
Thus, it is important to consult with local experts in the country of focus, or to hire someone who knows the culture to review trial materials before they reach sites and patients, Barrett says. “The same goes for your communications tactics,” she adds. “Be sure you have someone who understands the culture and can perform quality control before you launch any public communications.”
As an example, when Praxis considers names for a study, a list of the favorites is sent to transcreation experts for review. “We were recently working on a mental health study, and one of our proposed study names was the ‘Asana Study,’” Barrett says. “The study was recruiting patients in 12 countries, and while that name had no negative connotation in most, in Hungary, we were informed that the word might be misused by adding a ‘b’ at the beginning and a ‘z’ in the middle (as in ‘baszana’), which [would turn it into] a curse word in Hungarian.”
For best practices in more effectively targeting and engaging study participants, see the Special Features on “Getting Started with Using Social Media to Recruit Research Participants” and “Applying Behavior Change Strategies to Patient Engagement in Clinical Research” in this issue.
There’s been a big drive toward simplifying trial participation (for example, by decreasing the demands for so many visits to sites) and broadening access for study volunteers—one that’s only becoming more urgent in the midst of the coronavirus crisis. What kind of progress is being made on these fronts?
Technology advances certainly appear to be making headway in this arena, with study managers taking advantage of the ever-greater levels of connectivity now possible with their participants. For example, Science 37, a company with a focus on decentralized clinical trials, recently announced that it “has created a fully reimagined patient experience while introducing native support for iOS and Android operating systems. With this development, patients can not only participate from the comfort of their own home, but they can also do it with the familiarity of their own smartphones.”
Using their own devices, patients can learn more about a study, provide consent, schedule and participate in study visits, complete assessments, and communicate directly with the study team and investigators, all through a single platform, according to the company. The cloud-based platform is also touted as integrating workflow and processes for physician investigators, mobile nurses, and coordinators across the entire trial life cycle.
Meanwhile, Medable Inc., a software provider for decentralized clinical trials, recently announced the launch of its Patient Advisory Council (PAC)—a nationwide network of advocates who will advise Medable and its biopharma customers on ways to improve patient access, experience, and outcomes in clinical trials.
According to the company, the PAC “is a network of expert patient advocates, advisors, and caregivers with diverse backgrounds in patient engagement and a strong understanding of patient preferences. The patient-led council is dedicated to improving clinical trial access and efficiency by embedding patient voices and perspectives into every facet of clinical trials, with the goal of bringing innovative, life-improving therapies to more patients at a faster pace.”
Medable further plans to share patient insights with key stakeholders, including healthcare providers, biopharma companies, and clinical research organizations. Original PAC member and past ACRP annual conference speaker T.J. Sharpe, a melanoma cancer survivor and patient advocate, has been working closely with the company to develop the framework, initial guidelines, and best practices for how Medable can best incorporate the patient perspective; patient advocate and founder of One Rare Jennifer McNary serves as the PAC Chair for 2020.
“By giving patients and caregivers a much-needed voice in trial design and execution, life science companies can improve patient access, experience, and outcomes,” said Dr. Michelle Longmire, CEO and co-founder of Medable. “This is a unique opportunity for key stakeholders across the clinical trial landscape to work together and contribute their insights and experience to accelerate innovation. By integrating patient perspectives within our digital trials platform, we hope to offer patients a more human experience.”
From another announcement, this one made at the recent SCOPE 2020 Summit, we also know that Greenphire has teamed up with Roche to address the top hurdles patients face when participating in clinical trials. According to on-the-scene reporting, the companies co-presented findings from a recent global trial survey on patient convenience, highlighting the need to alleviate financial and logistical burdens from participants in order to maximize retention and engagement.
For other views on simplifying and enriching trial experiences for participants, see the “Science & Society” column on “Decentralized Clinical Trials: A Much-Needed Plan for a More Reliable Future” and the “Recruitment & Retention” column on “How to Recruit, Cultivate, and Grow a Clinical Trial Subject” in this issue.
Another aspect of subject recruitment and retention that has become an ongoing emphasis from many quarters of the enterprise is that of diversity among participants. What are stakeholders doing now to improve the involvement of underserved populations in clinical trials?
As just one example of how this situation is being addressed, a recent blog post from Clinical Research Pathways looked at how multiple sclerosis (MS), “an unpredictable, potentially disabling disease of the central nervous system…has long been viewed as a disease of white women of northern European ancestry, [but] also affects black, Latino, and Hispanic Americans.”
Researchers’ understanding of how common MS is among these populations won’t improve unless more minority patients are included in MS studies. During Multiple Sclerosis Awareness Month in March, Clinical Research Pathways shined “a spotlight on this disease and the need to increase minority participation in MS research,” noting that, “[if] we understand how the disease affects people of different races and ethnicities, we can develop treatments that work better for all MS patients.”
However, the blog points out, “Black and Hispanic Americans…face obstacles to treatment. One study found that these patients are less likely than white patients to receive care for conditions, including MS, in a neurologist’s office. Without this care, many minority patients end up in hospital emergency departments with more serious problems.”
Clinical Research Pathways encourages healthcare providers, researchers, patient advocacy organizations, and other members of the MS community to learn more about the MS Minority Research Engagement Partnership Network and take advantage of its engagement resources and toolkits.
For more insights on diversity in clinical trials, see the “Site Strategies” column on “Fostering More Diverse Trials Through Targeted Protocols and Other Tactics” in this issue.
Gary W. Cramer (firstname.lastname@example.org) is Managing Editor for ACRP.