- FDA’s recent second-in-command reflects on time at agency
- Abernethy will join Verily in July to head up clinical research
Amy Abernethy could see the clinical research system needed a major overhaul but that the federal government ultimately wouldn’t drive those changes.
The Food and Drug Administration’s No. 2 official left the agency in April to do just that. She’s slated to join Verily—Alphabet Inc.’s life sciences subsidiary—July 6 as its president of clinical research business, where she hopes to improve study designs and broaden the pool of people who are eligible to participate.
“The federal government has a role in moving the conversation forward,” Abernethy said in an interview. “But I think at the end of the day, it takes a combination of academia and tech companies and clinicians and patients to solve all of this.”
Abernethy’s comments echo the views of acting FDA Commissioner Janet Woodcock, who has bemoaned the fact that only about 5% of Covid-19 clinical trials have produced actionable results. Woodcock has said she wants to transform the clinical trials enterprise so more of them happen in places where most patients already receive care.
“How do we develop an infrastructure that is more patient-centric, and is as productive and efficient as possible, that allows us to test more medical products and health-care delivery capabilities because the infrastructure works really well?” Abernethy said, adding that the clinical research should ideally be integrated into health-care delivery instead of staying a separate enterprise.
“That’s the big problem to solve,” she said.
Returning to the Tech World
Abernethy is no stranger to the tech world. She joined the FDA in December 2018 from Flatiron Health, a startup focused on accelerating cancer research. She took on FDA’s acting chief information officer role while serving as principal deputy commissioner.
“She also has a proven track record of successfully creating a successful team approach to the interface of tech and biomedicine—no small feat,” Robert M. Califf, head of clinical policy and strategy for Verily and Google Health, wrote in an email. “She is a highly energetic proponent of integrating learning/research into healthcare delivery and including people/patients directly in the research enterprise.”
Califf, a cardiologist who led Duke University’s clinical research and translational medicine institutes, worked with Abernethy when she was a resident and then chief resident at Duke.
Both Califf and Abernethy had career paths that took them from Duke to the FDA to Verily, although they had divergent stops along the way. Califf served as FDA commissioner during the final year of President Barack Obama’s administration.
Two Years, Five Bosses
Abernethy’s time at the FDA didn’t overlap with Califf’s, but she worked under five appointed or acting commissioners in less than two-and-a-half years: Scott Gottlieb, Ned Sharpless, Brett Giroir, Steve Hahn, and Woodcock.
“Having five different bosses in a little over two years,” she said, “made it so that the things that I was working on had to be very specific to what I was doing, as opposed to a series of changing agendas. And that ended up working well, because then I was focused on the same thing.”
That work included improving the agency’s use of real-world data to regulate medical products, such as data collected from electronic health records. She also spearheaded the FDA’s technology upgrade plan to use blockchain, artificial intelligence, and secure cloud storage to evaluate the safety and effectiveness of new medical treatments.
“That’ll be important for building a new clinical trials infrastructure in the United States,” she said.
Goals at Verily
A top goal Abernethy has at Verily is to better pinpoint when it’s appropriate to use more conventional clinical trials or real-world evidence studies.
“We should be thinking about clinical evidence generation as a total concept,” she said. Clinical trials and real world-evidence studies “aren’t opposing concepts, but rather, should be used in complementary ways.”
But the challenge is how to get to the point. One way is to improve clinical trial recruitment to ensure the study population accurately reflects who will ultimately need the treatment—while ensuring their personal information is kept private.
Smarter study designs are also needed to take into account who’s in the study population, according to Abernethy.
“In many people’s minds a clinical trial is a clinical trial is a clinical trial. You randomize a patient between the current standard of care and the new treatment,” she said. But a better approach may be a platform trial that tests many treatments under one master protocol, or perhaps uses a simulated control arm.
She also wants to improve eligibility criteria for who can and can’t participate in studies. These criteria are often copied and pasted from study to study, potentially leaving out groups that could benefit without affecting the study results. Friends of Cancer Research and the American Society of Clinical Oncology have been working to broaden these criteria.
Leveraging Data
Abernethy said she wants to improve the use of data to make clinical research infrastructure better and more efficient. An example could be using wearables, electronic health records, and other technologies to collect long-term follow-up data on a new gene therapy product. But the initial study would still happen in a traditional clinical trial, “where the rigor of the traditional clinical trial approach really helps to cross check safety and efficacy endpoints.”
She also called for the need to remove operational burdens on the system. A study coordinator might have hundreds of tasks that need to be done in a week. Instead of sifting through dense documents, software could “just make it obvious what you’re supposed to do today,” she said. Such software could also help remove errors in clinical trials.
“Because if that 100-page protocol has on page 75 what you’re supposed to do for the patient today, but you’re looking on page 76, you may just miss the information that you need,” Abernethy said. Companies like Verily have the capability to do that, she noted.
Abernethy wants to spend the first 100 days assessing the landscape at Verily, what work the company already is doing, and build a roadmap for what’s next. “Verily built a ton of stuff and is like really poised, especially to move the decentralized clinical trial infrastructure side of the equation forward,” she said.
