The push for clinical trials 2.0

Presented by Guardant Health: The collision of health care and technology.

May 04, 2022 View in browser   By Ben Leonard Presented by Guardant Health The Big Idea The movement to modernize trials isn't new, but it gained steam amid the pandemic. | AP Photo/Taimy Alvarez REMAKING TRIALS: Cash is pouring in to support efforts to modernize clinical trials, which have long been plagued by inefficiency, lack of diversity and the inability to leverage data, among other issues. Even as funding for buzzy technology like telehealth and digital therapeutics dipped significantly in 2022's first quarter after massive gains amid the pandemic, clinical trial funding globally rose after hauling in $2.7 billion in 2021, according to a report from research firm CB Insights. The movement to modernize trials isn't new, but it gained steam amid the pandemic, which pushed many trials to lean on technology to conduct trials remotely. Traditionally, trials have been conducted in person, requiring participants to be on-site, which can make continued participation difficult for people in underserved communities. People of different racial and ethnic backgrounds can respond differently to different treatments, making diversity in trials crucial. Many features of clinical trials still look "circa 1995," including data collection, said Amy Abernethy, the former No. 2 at the FDA who left the agency last year to help modernize clinical trials at Alphabet's Verily. Verily's software aims to make it easier to participate in trials remotely and more seamlessly aggregate data. The push to overhaul trials includes mining more information from electronic health records, using telehealth in decentralized trials conducted partially or entirely virtually to draw in a wider range of participants and incorporating wearables to gather more data. "Everything is very inefficient, " Abernethy said. "Better conduct of clinical trials is partly software that makes it easier to participate … but a lot of it is understanding why people want to participate … How do you make it delightful?" The landmark 21st Century Cures Act set its sights on modernizing trials, and the FDA has set it as a priority for a number of years. "We have the beginnings of a regulatory environment that's welcoming modernization and also fostering it," said Sally Okun, executive director of the Clinical Trials Transformation Initiative, a partnership founded by Duke University and the FDA with members that include the NIH, Pfizer and PhRMA. Tech firms are vying to disrupt the old way of conducting trials and raking in cash. Huma and Reify's Care Access provide platforms and infrastructure for decentralized trials, while ConcertAI and Verana aim to bolster data use. A number of obstacles remain. Organizations are still having difficulty making sense of the swath of health data, said Tom Lehmann, Accenture's life sciences R&D global lead. Regulations can also get in the way of innovation, experts say. "The FDA was built for an era where this is not how work is done," said Bob Wachter, University of California, San Francisco department of medicine chair, saying the agency is in a tough position. "If they're too slow, you yell at them for being too slow. And if they're too fast … people yell at them for that." Not everyone's ready for the new tech, either. On a scale of one to 10, clinical trial sites rate their confidence a five on being ready to handle decentralized trials, according to a 2022 report from Florence Health. "Technology cannot solve everything," said Shrujal Baxi, Verana Health's senior vice president of clinical and scientific solutions. "What technology can do is to at least facilitate the conversation and bring forth options that maybe previously were not brought forward." Welcome back to Future Pulse, where we explore the convergence of health care and technology. Share your news and feedback at bleonard@politico.com or @_BenLeonard_.    A message from Guardant Health: Modern cancer screening technologies demand a modern review process. Learn more about Guardant Health.   Tweet of the Week Ilyse Hogue @ilyseh: "I have COVID. I was just told by my healthcare provider that they can't prescribe the antivirals through telemedicine. How i[n] the name of God and science does THAT make sense? They want me to take my virus laden body somewhere to get the drugs to make it less virus laden?" Washington Watch ROE RIPPLE EFFECTS — The Supreme Court voted to overturn the landmark Roe v. Wade decision protecting abortion rights, according to aninitial draftmajority opinion obtained by POLITICO's Josh Gerstein and Alexander Ward. If the decision holds, demand is expected to surge for FDA-approved abortion pills, which can be prescribed virtually. Data from abortion-rights research organization Guttmacher Institute found that medication abortion made up more than half of abortions in the U.S in 2020. But most patients are misinformedabout the pills and how to get them, according to abortion-rights advocates, medical groups and national polls. Many states have prohibited clinicians from prescribing the pills via telemedicine, and more could do so, with Louisiana's Senate nearly unanimously passing a bill last week banning the prescribing of abortion-inducing drugs online. Telehealth advocacy groups in Washington, D.C., have stayed away from the issue publicly.   INTRODUCING DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED:  Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today.     Around the Nation CEREBRAL UNDER FIRE: Virtual mental health company Cerebral, which provides patients with therapy and medication, faces a lawsuit from a former executive who claims the company aimed to prescribe stimulants for "100%" of ADHD patients. "When Cerebral determined that patients who were prescribed stimulants were more likely to remain Cerebral customers, the CEO directed Cerebral employees find ways to prescribe stimulants to more ADHD patients to increase retention," according to the lawsuit. Matthew Truebe, former vice president of product and engineering, claims the company fired him after he raised concern about its practices. Cerebral, which named Olympic gymnast Simone Biles as its "chief impact officer" last year, didn't respond to a request for comment. The Wall Street Journal reported in Marchthat current and former employees felt pressured to prescribe stimulants. In a Q&A session Sunday at the American Telemedicine Association's conference, Cerebral CMO David Mou backed the company's practices but said mistakes were made. ATA CONFERENCE RECAP: I traveled to Boston for the American Telemedicine Association's annual conference this week. Here are some key trends I heard in conversations and sessions: RPM touted: Many attendees were bullish on the potential of remote patient monitoring to bolster health outcomes. Joe Kvedar, chair of ATA's board and a Harvard medical school professor, said key questions are when will more "efficient" modes of care like remote monitoring take hold and what is the proper proportion of virtual to in-person care. PHE anticipation: The industry is waiting to hear when the Covid-19 public health emergency that keeps expanded telehealth access in place will expire. The earliest it could expire is July, and HHS Secretary Xavier Becerra has pledged to give 60 days' notice — which could come in the next two weeks. Megan Herber, director at Faegre Drinker who works for ATA's lobbying arm, said at a panel that the group is pushing for a two- to three-year extension of the rules relaxed during the pandemic after the emergency is lifted. Congress extended several provisions expanding Medicare virtual-care access for five months after the emergency expires. Marketing too hard: Panelists said that digital health companies need to be more measured in their marketing. "Sometimes companies are going way too far" in selling digital health products as panaceas, said Michaela Balderston, communications chief at Tusk Venture Partners. "It's a really naive way to approach it."   A message from Guardant Health:   The Next Cures REMAKING GOV'T APPROACH TO TECH: Alondra Nelson, the first Black woman to lead the White House's Office of Science and Technology Policy, is being asked to remake the role of OSTP director after Eric Lander's resignation, Nancy Scola reports in a deep dive for POLITICO Magazine. "With AI's discriminatory potential becoming clearer by the day and a new system of digital currency quickly going mainstream but still mostly invested in and built by white men, Nelson and supporters are hoping that right now is a moment to center questions of who innovates, and who benefits from it," Nancy writes.   STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president's ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.     What We're Clicking On STAT's Casey Ross has this headline: "Tough questions, few answers: The FDA wrestles with its approach to AI in medicine." Drug mistakes are just "a few keystrokes away" at U.S. hospitals, Kaiser Health News' Brett Kelman reports. Digital health companies are bracing for a "Post-Roe world," TechCrunch's Natasha Mascarenhas reports.   A message from Guardant Health: The USPSTF drives access to new screenings and insurance coverage for Americans. It's time for their review process to match the speed of innovation. Learn more about Guardant Health.     Follow us

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