19 January 2022
The pharmaceutical industry picked up digital clinical trial tools during the pandemic that can also be used to tackle the lack of diversity in research. So that’s it. The issue is solved.
Of course, things are not that easy, as a panel of experts attested during a session on new paths to trial diversity at Fierce JPM Week, which kicked off Tuesday. Many major pharmaceutical companies were already working on diversity strategies before the pandemic, but, when the world shut down to try to stop the spread of the deadly disease, those plans had to kick into gear on the spot.
“The crisis really accelerated and caused breakthrough thinking in a way that the industry may have been headed, but made it happen right now,” said Greg Rotz, a principal with consulting firm PwC.
Rotz said his clients’ lessons from the pandemic came down to three pillars: prediction, adaptation and decentralization. These were common themes among the panelists.
Here to stay are hybrid clinical trial models, which combine decentralization, real-world data and other capabilities to give more patients the opportunity to participate in trials, according to Gaelan Ritter, head of analytics innovation and digital health at Bristol Myers Squibb.
“It was one of those situations at BMS where we were heading in that direction, but not nearly as fast as we should have been. Obviously, if we had known the future, not nearly as fast as we would have been,” Ritter said.
What really brought things home for Craig Tendler, M.D.—who is the global head of late-stage clinical development, diagnostics and medical affairs for hematology & oncology at Johnson & Johnson’s Janssen unit—was when patients stopped coming in for tumor evaluations. But they also saw patients in the company’s multiple myeloma trials having severe complications from COVID-19.
“It was a big aha! moment that we had to pivot quickly to, most importantly, maintain patient safety in our trials, which was the biggest priority,” Tendler said. Also important was maintaining integrity of the trials that could go on and collect data to perhaps support regulatory approvals for diseases well beyond COVID-19.
Janssen adopted processes to allow patients to stay home and use local labs for evaluations. The company even shipped medications, all in consultation with regulatory authorities to ensure study integrity was maintained.
Ritter said one of his company’s key takeaways was that simply understanding a person’s race, age and gender is not enough. BMS, which ran 25% of its clinical trials in diverse communities across the country last year, learned a hard lesson as COVID-19 spread that the traditional understanding of what diversity even means may be wrong.
“You can imagine a diverse metro area on the East Coast and the Midwest and the West Coast, those behaved totally differently during the pandemic,” Ritter said. That led BMS to the realization that it had to “get a more holistic look at what that diversity means, and what really defines some of those populations.”
To that end, Ritter said they noticed that regionality made a big difference as COVID-19 spread. To truly address diversity in clinical trials, companies need to consider urban/rural divides, socioeconomic class, employment status and more, he said.
This moment, where the pharmaceutical industry is going all-in on addressing clinical trial diversity, coincides with a massive explosion in the collection of health data, according to Jessica Mega, M.D., co-founder and chief medical and scientific officer of Alphabet subsidiary Verily. This information is coming from case reports, health records, digital biomarkers and so on.
“If we can start to combine those, you create longitudinal journeys that help accelerate research, and it’s been an area that we have been particularly interested in and feel that it is part of this next generation of inclusion,” Mega said. Regulators in particular have been interested in providing guidance on how to use more real-world data to accelerate new drugs, devices and digital tools, she added.
Data can be used to help assess trial outcomes, according to Ritter. This takes some of the burden off trial patients and sites and places it onto software systems.
Rotz noted that the FDA managed to approve more than 50 drugs in 2021, which is a testament to how companies kept things moving in the most difficult circumstances.
“It's important that we don't take the ‘why’ for granted. Why are we doing this? I don't think we can say it enough,” Rotz said. One reason is to ensure that as medicines get more complex—think gene therapies and cell therapies—efficacy and safety are well understood in all populations that may receive the treatment, he said. And another is, simply, it’s the right thing to do.
“Clinical trials [are] the way that communities get access to the next generation of innovative medicine and investigational products, and having big parts of our population that don't have access—especially if they want and would be happy to participate in those trials—is a great tragedy for society,” Rotz concluded.Print
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