June 18, 2020 | The COVID-19 pandemic has created a “Wild West” response from the FDA, institutional review boards, and clinical trial sponsors to keep studies running and patients safe from an invisible enemy. When the dust settles, the industry is unlikely to look the same—and, it is hoped, drug developers won’t need a second scolding from regulators about the virtues of innovation.

Clinical trials across the board have become at least partially decentralized, including study visits happening via telemedicine and informed consent happening every which way but in person. Like their counterparts in clinical medicine, investigators and sites have been forced to pivot to the new normal where interactions require digital bandwidth or a decent phone connection as well as a new workflow and etiquette norms.

For weeks now, I’ve been talking to frontline providers about the sudden transition from in-person to on-screen visits and how some healthcare organizations were clearly better positioned to make the leap because they had already moved beyond the dabbling stage with the technology. That launched an ongoing series of articles on the topic of telemedicine in Diagnostics World News that spilled over to Clinical Research News with the latest installment, “The Great Experiment In Taking Trials Virtual.”

The concerns and experiences of clinical practitioners and diagnosticians have some natural crossover with that of study sponsors and CROs as well as clinical trialists who often wear both hats. Selecting vendor partners and deciding which patient groups to prioritize were just a few of the immediate hurdles, providers have shared. Planning for surges in COVID-19 cases that might arrive sooner than expected, reappear for a second time, or never materialize at all has required nimbleness of unprecedented proportion.

The shift to digital health has also exposed inequalities in payment practices and broadband access, as well as created a living laboratory for establishing the cost effectiveness of telehealth as a care delivery model across a diversity of populations and settings. But the enabling regulatory and reimbursement policies remain provisional, and the jurisdiction of state medical boards is within borders that televisits seamlessly cross.

Clinical research falls outside the purview of medical boards, opening up the possibility of decentralized trials where world-renown specialists could serve as the principal investigator on a trial across every state in the nation. The tricky part would be recognizing when they’re a scientist and not a doctor where the state licensing rules are still at play.

Many clinicians predict telemedicine will be the new standard of care; in fact, more and more of them are beaming in to see patients on a full-time basis.

The long-term situation for trialists is murkier. The pandemic has elevated the status of clinical research to a new high that may or may not translate into making individuals easier to enroll and retain in trials. It may well depend on sponsors’ willingness to trust study participants and give them more control and choice—and understand how arduous it can be to participate at all.

I invite you to join me on my journey of discovery about the application and proper place of telemedicine and the decentralized trial model on clinical as well as research care. Immediately below are links to the stories published to date. Please send me your feedback, including where you’re furthest behind on the learning curve and could use some expert guidance.

—Deborah Borfitz, Senior Science Writer, Clinical Research News

UW Medicine: Pandemic Could Give Long-Term Boost To Telemedicine

Long View On The Role Of Telehealth In Primary Care

Telemedicine Not So New To Nursing Homes and Rural Hospitals

Making Choices With Telemedicine: Stanford’s Approach

Which Way Forward With Telemedicine? The Regulatory Perspective

The Great Experiment In Taking Trials Virtual