As devastating as the COVID pandemic has been, one positive result is the increased attention it has shed on the pharmaceutical industry. Because of the quest to stop the spread of COVID and save lives, the public is now more aware of the difficulty of finding cures and vaccines, and the need for clinical trials. One report has even showed an improvement in the reputation of pharma.
“With COVID there's a greater understanding about clinical research,” said Cassandra Smith, director, diversity & inclusion in clinical trials at Janssen, speaking on a November 2020 Clinical Leader Live panel on patient diversity. “There's never been another time when people were discussing trials and clinical research at dinner tables and in social circles. People are now more aware of clinical research and have a better understanding of what it is. It's unfortunate this understanding is the result of COVID, but it is really nice to see people wanting more information about trials and clinical research.”
Although the understanding of clinical research has increased, that will not necessarily lead to improved patient recruitment in trials, especially among the much-needed minority populations. In order to move the recruitment needle, a different approach will be needed by pharma companies. Smith believes future efforts will require heart and will need to lead with humility and empathy.
“We need to have a strong desire to move things forward and not be afraid to fail quickly,” says Smith. “We need to connect with people and truly understand the position certain individuals are in. Not everyone has a fast broadband connection or access to the same technologies. There are privileges that some segments of society have that others do not. It’s important to start looking at people as individuals and understand where they are and what barriers they face. That will be required if we want to demonstrate humility and connect on a more human basis.”
Conversations Lead To Understanding
Companies may understand the need to lead with empathy and humility, but they may not know how exactly to do so. Smith believes the effort must begin with understanding what motivates and drives the patients you’re trying to recruit. When it comes to ethnic groups that are underrepresented in trials, the way they interact as a culture and a community is based on principles of family, friendship, and social gatherings. Layer on some of the mistrust that exists in these communities due to years of systemic racism, and it is easy to see why traditional recruitment methods have fallen flat.
“What will be required going forward are virtual or face-to-face conversations with patients and their families,” says Smith. “For example, at a public event where Janssen had a booth set up, I was able to engage with many individuals. A colleague and I had a conversation with a gentleman that went on for an hour and a half. He had many questions we were able to answer, and we learned about his distrust of medicine, government, science, and clinical research. By having that face-to-face meeting, we were able to understand his concerns and help him see clinical research in a different light.”
Today that individual may not be a cheerleader for clinical research, but Smith believes he has a greater understanding of it and can now share those insights with others. Mistrust can lead to beliefs and assumptions that are not true. Candid conversations may be what is necessary to alleviate them.
What Janssen Is Doing
Janssen has a strategy that revolves around removing stumbling blocks that impede patient participation in trials. It was launched two years ago to overcome the patient diversity challenge. For other companies contemplating a similar approach, Smith recommends making your plan strategic and tactical.
“In our strategy, we focused on things we could be doing but were not currently doing,” notes Smith. “That might be something as simple as looking at your protocol to see if you might inadvertently be excluding certain groups of people because of unnecessary barriers to their participation. The barrier might be something like a biometric measure or a site that is only open between the hours of 11 AM and 3 PM.”
Change management within Janssen has been another area of focus. Gaining the trust of patients and raising awareness of trials is another. Although the company will not be able to speak to every person for an hour and a half, Smith notes those face-to-face interactions are an important part of Janssen’s strategy as community interactions are vital to both disseminating information and gaining trust. The company also has a campaign underway called Research Includes Me. An educational website provides information about clinical research with a focus on minority visitors. Patients from diverse ethnic backgrounds helped create the site.
“The Center for Information and Study on Clinical Research Participation (CISCRP) also has an event called Aware For All that is held five times per year around the world,” notes Smith. “We have been working with them for a couple years and that effort has morphed into a collaboration across the industry where sponsor companies have banded together with other organizations to promote clinical trial information and education primarily to communities of color.”
Finally, Smith notes Janssen is always trying to grow its pool of researchers and investigators who have access to patients in minority populations. We often hear that patients want to go to doctors who look like them. While that may not be true of everyone, Smith does stress the importance of having more investigators, physicians, and nurses of color, which is another area of focus for Janssen.
Planning Leads To Success
Smith cites the company’s recent LOTUS study as an example of planning in advance for diversity success. She notes the team involved in that study had not only a goal but a focus on diverse patients from the start of the trial.
“I think one of the most important lessons we took away from LOTUS was the importance of planning,” she says. “The team set a goal for the number of women of color it hoped to recruit. That gave them a number they could aspire to reach. It then focused on diversity when designing the study, conducting feasibility, selecting sites and partnerships with advocacy groups, and outreach to the community.”
The LOTUS study was for patients of Lupus, a disease that impacts women of color at a greater rate than Caucasian women. The goals were shared with sites and investigators early on, enabling them to help with the recruitment effort. The study was able to recruit 45 percent of its participants from minority communities. Janssen was also able to complete recruitment, as well as the clinical trial, on time and on budget.
Implement Best Practices
A successful study can often lead to the implementation of best practices. Several of Janssen’s learnings are now best practices that Smith was able to share. They are:
Plan early and with a focus and intention to have diverse enrollment.
Set the tone for diversity with your sites and study teams and monitor their progress.
Encourage sites to reach out to all potential patients.
Do not underestimate the value of connections with communities.
Monitoring the progress of sites is important to Smith and something Janssen will not only monitor, but follow-up on as well.
“That step is critical to achieving diversity in your trials,” says Smith. “You cannot wait until recruitment is complete and then realize the numbers are not where you need them to be. We use dashboards to monitor the progress of sites in real time or near real time. This is not a situation where you can afford to wait weeks before monitoring the data. There needs to be a way for companies to look at benchmarking against actual enrollment at the site level. Only then can you understand how a site is performing, how it has performed historically, and what adjustments and contingencies need to be made.”