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Bloomberg Law – Clinical Trial Tweaks Forced by Virus Should Stay, Hahn Says

Bloomberg Law – Clinical Trial Tweaks Forced by Virus Should Stay, Hahn Says

The remote monitors and telehealth check-ins made necessary by the coronavirus could become permanent fixtures of new clinical trials going forward, FDA Commissioner Stephen Hahn said.


The pandemic has delayed or even stopped clinical trials unrelated to Covid-19, including a study testing a Novartis AG cholesterol drug. It has also forced doctors to rely more on telehealth to treat patients. Hahn said those experiences should inform how the Food and Drug Administration updates a clinical trial system agency leaders have previously described as “clunky” and broken.


“How do we revise, modify, or modernize, if you will, our approach to clinical trials? What can we do at FDA to make it easier to incorporate telemedicine, remote monitoring, and other techniques to actually facilitate the development?” Hahn said Wednesday at BIO Digital, the first virtual conference of the Biotechnology Innovation Organization.


Hahn didn’t specify what might change for clinical trials, but cancer centers have limited the time patients spend in hospitals by increasing telehealth options and allowing local doctors to handle routine work.


Health-care teams also have begun sending oral medicines directly to patients in addition to remote consultations, Jeff Allen, president and chief executive officer of Friends of Cancer Research, said. If put into regular practice, these changes could make it easier for patients to participate in clinical studies, he said.


Research institutions also have taken steps to streamline start-up and modification processes or the use of master protocol approaches, which Allen said can significantly speed the rate by which new trials can get started. Master protocols test multiple drugs or multiple subpopulations of patients at once, eliminating the need to develop new protocols for every trial.


“In response to Covid-19, significant efforts have been made to streamline and maintain high quality care while minimizing the need for patients to be at the hospital,” Allen said. “Retaining those efficiencies into the future can be good for all.”

Boosting Efficiency

Clinical trials are the longest and most expensive part of the drug development process, and there’s been a push from the FDA, Congress, and patient groups over the years to make them more efficient through innovative models and by incorporating electronic health records and other patient-generated data.


The FDA issued guidance in March on conducting clinical trials in a way that prioritizes patient safety but accounts for necessary changes amid an infectious disease outbreak. Usually, researchers and drug companies must clear any changes through an ethics board. The guidance allowed researchers to immediately move on-site visits to teleconference provided they notify the FDA and receive a subsequent review by an ethics panel.


Those changes apply to studies that are already underway, and Hahn indicated he wants to find ways to implement those alternatives from the beginning.


“We could do all the regulatory flexibility we want in the middle and the back ends. But if we can’t get the clinical trials done because we don’t have flexibility around how those visits occur, we’re not going be able to move things forward,” he said.


As a radiation oncologist who’s conducted his own research, Hahn said he’s interested in taking the adaptations health-care systems made during Covid-19 for routine clinical care and parlaying those adaptions into new approaches for clinical trials.


“It could really help us expedite and maybe we get that cycle time even shorter if we use some of these processes moving forward,” he said.…