GSK is doubling down on its efforts to make clinical trials more diverse, starting with defined enrollment targets and training its clinical R&D workforce on issues around diversity, equity, inclusion and bias in healthcare.
The pharma giant announced in early May that it had partnered with Blue Level Training to provide educational materials to the roughly 10,000 principal investigators and staff who have face-to-face interactions with patients in clinical trials. The Blue Level partnership followed news that the company is aiming to have enrollment for at least half of all phase 3 trials in 2024 reflect the populations most impacted by the disease the tested therapy is designed to treat.
Until now, most pharmas—including GSK—have relied on hindsight to assess how well enrollment diversification efforts are working, Michel Reid, Head of Global Demographics and Diversity at GSK, told Fierce Biotech in an interview.
“It’s really difficult for an industry as a whole to know how we’re doing,” he said. “I can’t speak for [the efforts of] anyone else outside of GSK because it’s highly variable, but we’re all trying to do the right thing.”
A tangible enrollment goal is the natural next step in GSK’s push to make its clinical trials more representative of the racial, gender and age demographics that its products will ultimately serve. In 2023, the company set and met its goal of submitting FDA-recommended diversity action plans for all of its phase 3 clinical trials and many of its earlier-stage trials, too.
“You can’t accomplish anything unless you’re measuring, and you can’t measure anything unless you have a plan on what you’re trying to accomplish,” Reid explained. “We want to make sure we’re studying the right people.”
But plans don’t mean anything without action, he added.
“The 50% number is centered around our excellence in executing the plan and actually doing all of the effort to make sure that those plans come to fruition, and that our studies actually have the right types of people, the composition we’re looking for,” Reid said.
Core to that effort is establishing trust with the populations GSK is aiming to enroll. There are many layers of well-justified skepticism that may deter people from marginalized populations from participating in clinical trials, from medical research's dubious history in past decades to poor direct experiences with doctors today. This is especially the case for studies involving sexually transmitted diseases like HIV and hepatitis B, which are already sensitive subjects for patients to discuss with their doctors.
The bar for trust is even higher when a pharmaceutical company with financial interests gets involved, Reid said. Transcending it requires transparency and a willingness to answer hard questions.
“What we have learned along the way is [to explain] that especially on the R&D side, everything we’re doing is centered in science,” he said. “It’s explaining that what we’re doing isn’t centered around making money, but really trying to understand how to produce a medicine, a vaccine, or some sort of therapy or device to make someone’s life better.”
It also helps to be part of the community outside the context of clinical trials. To do that, GSK has engaged with patients through partnerships with groups like the Tigerlily Foundation, a breast cancer-focused nonprofit that is especially active in the Black community and other communities of color.
“A lot of our work with [the Tigerlily Foundation] has had no direct relationship to our clinical studies,” Reid said. For instance, GSK recently worked with the nonprofit on educational events for women with breast cancer in three different cities.
Site selection is another major factor in meeting enrollment goals, not only with regards to geography but also the type of location that hosts a trial, Reid said. Though major academic research centers often come to mind when people think of clinical trials, only about 25% of the population GSK wants to enroll have access to such sites. Decentralization has thus become a key tactic in meeting its goals.
“Sometimes it’s technology, sometimes it’s different types of travel,” Reid said. For instance, “sometimes you can go to your local pharmacy instead of driving all the way into the city to have your blood drawn, or a nurse might be able to come to you. And there are some things you can do through a device.”
Once patients do agree to take part in a trial, it’s essential that staff maintain the bond of trust by understanding their experience. That’s why educational programs like the one GSK has set up with Blue Level are so important, Reid said.
“Our goal with that content was to make sure that everyone who works on behalf of GSK is well-equipped to interact with anyone who might come in the door,” he explained.
“It doesn't matter what they look like, how they arrived, where they are economically, their religion, their skin tone, their gender—if they are eligible for one of our studies, we want them to feel welcome in that process.”