Getz Optimistic About Clinical Trials Industry Hitting Reset Button
The impact of COVID-19 on the clinical trials industry will be far-reaching and many of the changes sponsors and sites are making to deal with the coronavirus outbreak will continue to be adopted long after the pandemic is under control.
Ken Getz, deputy director of the Tufts University Center for the Study of Drug Development (CSDD), said there have been three key takeaways from the clinical trial industry’s response to the COVID-19 emergency.
First, the pandemic has shown that the industry is remarkably resilient and can be flexible and adaptive as well, he said in an interview last week that foreshadowed remarks he made on the topic at a presentation to the Association of Clinical Research Professional’s 2020 conference.
Mobilization of technologies and staff to accommodate different approaches — including virtual trials, remote monitoring, home-based activity, risk-based data management and mobile devices among others — has helped to avoid disruptions that could have led to cancellation of studies, he said.
Even after social distancing and precautionary steps move out of routine clinical activity in a post-pandemic world, these extra measures will remain in the background ready to be deployed if another health crisis arises, Getz said.
And some approaches that proved useful to enhance social distancing, like virtual trials and remote monitoring, were already being explored for convenience and will likely continue to see growing use, he said. The forced use of such tech-based modifications to traditional procedures may serve to give sponsors and regulators confidence that they can be effectively deployed in non-emergency conditions.
Getz noted that researchers have been moving away from personal site visits for some time in many types of trials. Some studies will always require in-person site visits — such as oncology, rare disease or other trials where patients cannot readily self-administer medication or diagnostic tests — but many will likely make greater use of decentralized approaches. He also argues that he expects to see continued decentralization of clinical trials as current protocols are evaluated and new ones developed. A challenge may lie in balancing the need for both decentralized trials and the human touch that patients are used to and need when it comes to their health.
The increased use of telehealth, videoconferencing, remote monitoring and other non-traditional means of interacting with and getting data from patients has been a silver lining to the pandemic cloud, experts say and Getz agrees. When more assessments and procedures can be done remotely, participation in clinical trials is easier and more convenient for patients; additionally, these options can ease the scheduling burden for study sites. By making it easier for patients to participate, decentralization should also allow for greater participation among diverse patient populations. And this choice can help aid enrollment and retention over the long term.
The second key takeaway, according to Getz is that significant collaboration is possible among researchers.
“The pandemic has created more focus on trying to solve problems and support successful management of necessary adjustments,” he said. “The amount of open collaboration has been remarkable. It’s very encouraging to see.”
Getz said he has talked to a number of colleagues who were opposed to have people work from home pre-pandemic. Now they “have completely changed their view of employees’ ability to be productive working remotely,” he said. Also, he says, so many companies that were formerly resistant to remote monitoring are “now embracing and using and contracting with CROs to manage more studies like this.” He added that the pandemic “has given a much wider lens into how these activities can be used to trials’ benefit. When we hit the reset button, we’ll see a steeper adoption of all of these practices.”
The final takeaway from the pandemic, according to Getz, is that drug sponsors and regulatory agencies have shown themselves capable of flexibility. There has been a growing receptivity to making adjustments and accommodating some modifications that may defy conventional practices to make sure studies are continued and patients served and informed.
For instance, the FDA’s recent guidance allowing researchers to make more modifications to study practices is a hopeful sign that regulators may be gaining more confidence in novel approaches, Getz said, adding, “We may see a new normal once we put this pandemic behind us, and move beyond very partitioned, pilot activities to see broader use of different approaches.”
One area that hasn’t really been scrutinized as part of the COVID-19 response within the clinical trial industry is the legacy drug development paradigm, which is dependent on completion of randomized clinical trials, Getz said. This takes a long time to complete, and crises like the novel coronavirus outbreak, where time is of the essence, highlight this weakness.
It is uncertain whether a challenge to that paradigm will arise in the wake of this pandemic, however, he added. The real question lies in regulator receptivity.
“There’s no appetite on the part of sponsors and those involved in research execution to completely transform paradigm without regulatory support,” Getz said. So far, innovative approaches like remote or virtual trials have been molded to fit into that classic paradigm, so it continues to take a long time to get new treatments or vaccines to patients who need them.
“I’m hoping that as more voices demand these sort of bold and transformative activities, regulators and the federal government will step up and be more disruptive and radical. When lives are at stake and we believe the mantra that we put our patients first, that is when we have to do it.”