By Deborah Borfitz 

February 18, 2022 | Ways to effectively engage local communities in clinical research—as trial participants, study sites, and referral partners—was a top topic of conversation at the recent Summit for Clinical Ops Executives (SCOPE) in Orlando, Fla. Karen Correa, head of global clinical operations at Takeda Pharmaceuticals, focused on tactics for educating and motivating healthcare professionals to be ongoing clinical trial referrers, while Kafayat Babajider, associate director of patient portals for Janssen Research and Development, provided a status report on its six-month-old, insights-driven My Trial Community platform.

Creating a referral process for clinical trials is an underutilized but high-potential area for increasing education, awareness, and access to studies by underrepresented populations, says Correa. Despite effort by multiple organizations—including the Pharmaceutical Research and Manufacturers of America, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, and the Biotechnology Innovation Organization—people are still confused and hungry for information and racial and ethnic minorities remain underrepresented in studies. 

The focus of efforts over the past three decades has been initiatives aimed at recruiting more African Americans and Hispanics, she says, but “diversity of thought” is the real need. Toward that end, Takeda’s PAVE strategy is to partner (P) with existing community stakeholders, acknowledge (A) opportunity barriers, verify (V) that diversity and inclusion goals represent real-world data, and enhance (E) the diversity of investigative site staff. 

The overall vision, says Correa, is to “foster partnerships and implement strategies focused on education, awareness, and access to support the diverse inclusion of patients in clinical trials.” Her talk was on the P and E portions of the puzzle. 

Wrong assumptions can be made even when partners look like one another, says Correa, noting that early on she mistakenly believed that all black-skinned individual were African American. Cultural competence must be learned, she says, and “it changes every day.”

She views community engagement in layers, with tier one representing community education centers, tier two community referring partners, and tier three community investigative sites. Takeda seeks to partner with a variety of community stakeholders, Correa shares, among them healthcare professionals and centers, Federally Qualified Health Centers, community-based health practices, integrated healthcare systems, physicians, nurse practitioners, pharmacists, and dentists. 

The company separately seeks to engage community leaders, organizations, and institutions running the gamut from religious and government health officials to affinity groups and social and fraternal clubs that want to help, she adds.

Targeted education centers (e.g., library) are located near a clinical investigative site and provided with learning tools to “plant seeds” in the community, explains Correa. Referring partners are also within a certain boundary of an investigative site and might be compensated for sending letters to all their friends telling them about a relevant trial opportunity.

The goal with referring partners is to help build their relationship with an investigative site, she says, without their having to do the homework for themselves. They are paid for their time in recruiting patients and looking at the study protocol. 

Relationship-building is likewise key to encouraging more investigative sites to work with Takeda, Correa continues. Education and tools for staff are provided as needed, and the nearby education center and referring partners can be tapped to build the new site’s recruitment base.    

Takeda’s “stake in the ground,” she adds, is reflected in the hiring of LaShell Robinson as director of diversity and inclusion in clinical trials. “It’s a department, not a workstream” and utilizes real-world data for referral and education purposes. 

Patients must be referred through their physician because that relationship is what makes them a better trial participant, Correa says. While she also likes digital approaches to patient recruitment, some people simply respond better to the high-touch approach. 

Under the best of circumstances, building a referral network for trials is a one- to two-year process, concludes Correa. “It won’t be a quick fix.” 

Patient Feedback 

Janssen’s My Trial Community platform is designed to shape the clinical trial experience by educating trial participants on what to expect, empowering them with a selection of their own personal data and study results, and engaging them as valued stakeholders through more regular feedback loops. Much has been learned from patients and other stakeholders since the site was launched in August 2021, says Babajider, who shared some of the key insights at SCOPE. 

My Trial Community seeks to harmonize the clinical trial process, so patients feel engaged and prepared for the study experience, she explains. The digital platform provides education to individuals before they join a trial, access to a Janssen global trial finder, and ongoing support for the entire clinical trial journey once they sign up. 

Study enrollees get an overview of what they’ll experience at each visit as well as reminders, says Babajider. Feedback on the trial experience is solicited and trial results are shared with participants when all analyses are completed.

A feedback loop with identified stakeholders helps to keep the platform patient-informed, she says. The most urgent, valuable, and viable patient insights get prioritized for action.

Exemplifying the power of the patient voice is a reimagined My Trial Community website and introductory video. A patient advisory board identified the need for the site to have more accessible features and controls as well as enable patients to interact with one another, says Babajider, and those changes will be enacted. 

“Trust is the biggest thing,” she says, highlighting the importance of talking to patients in a way that is “relatable and not one-sided.” Their own primary care physician is integral to their decision-making, as is talking to others who have been through the process.

A video about clinical trials, initially “animated and pedagogical,” was not helpful in building trust, Babajider continues. To make it more humanized and personal, a storytelling series was created and will now be taken back to the advisory board for their feedback. 

Based on a short clip Babajider played, before-and-after versions of the video were strikingly different in multiple respects. Rather than expounding on the definitional aspects of a clinical trial, the new version begins with a woman named Alicia sharing her journey with an HIV clinical trial.

The patient is the focus, and she is set in real-world locations (including her home), speaking plainly about dealing with the stigma of her diagnosis, her desire to give back to her community, her concerns about study participation, and why she ultimately enrolled: she wouldn’t be in pain, the treatment wouldn’t make her sick, and she could later choose to opt out. Best of all, Alicia shares, she would only have to take one pill a day. 

Future priorities are to move faster and more efficiently on the Janssen’s “ask, listen, act” mantra, says Babajider. Participants are partners and integral to identifying the best insights to scale.