COVID-19 Adaptations Could Help Trial Industry Move Toward More Flexible Future
Continuing clinical trials in the face of the COVID-19 pandemic has posed myriad challenges to an industry some experts have characterized as largely unprepared for a public health emergency. But lessons learned from operating under pandemic conditions may accelerate innovations the industry currently is only toying with, including decentralization of clinical trials and technology-aided remote monitoring.
One key lesson, according to Jill Johnston, president of WCG Clinical’s study planning and site optimization division, is that drug sponsors and clinical researchers need to be better prepared to handle unexpected emergency situations. Most studies lacked a risk plan, including trigger points and contingency plans, she said. And even those that did develop plans at the start of a trial have not kept them updated and ready to adapt.
Sponsors’ project management teams had not dealt with global catastrophes, she explained. While they may have dealt with a regional emergency, having all sites affected at once was a new experience for most. There is also a lot to be learned about how to manage clinical supplies in this situation, Johnston added, as well as how to shift to remote consent or e-consent procedures if needed.
But the scramble to adapt has produced some positive results. Ken Getz, deputy director & research professor at the Tufts University Center for the Study of Drug Development, said there have been several 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, Getz said, and can be flexible and adaptive as well. Mobilization of technologies and staff to accommodate numerous different approaches — including virtual trials, remote monitoring, home-based activity, risk-based data management and mobile device monitoring, among others — has helped to avoid disruptions that could have led to cancellation of studies, he said.
But the need for social distancing will continue to be a challenge for some time, said Tricia Barrett, senior vice president and managing director at Praxis, which has about 70 clinical trials under way around the world. This makes face-to-face visits particularly challenging, especially in pediatric trials or other studies where caregivers are an important part of the care team.
And 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.
Some approaches, 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 nonemergency conditions.
Getz noted that researchers have been moving away from 100 percent 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. Barrett said she 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.
Increased use of telehealth, videoconferencing, remote monitoring and other nontraditional means of interacting with and getting data from patients has been a silver lining to the pandemic cloud, Barrett noted. When more assessments and procedures can be done remotely, participation in clinical trials is easier and more convenient for patients. These options also 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.
Jen Horonjeff, founder and CEO of the patient-focused Savvy Cooperative who sat on a panel at Eye for Pharma’s virtual conference earlier last month, agreed. Asking patients what they want and need as part of clinical trial participation is important to ensure adequate diversity and inclusivity in study populations.
Where remote monitoring and virtual clinic visits were once considered nice-to-have options, they are now viewed as must-have, Johnston added. She forecast that there will be a deeper dive into what patient visits can continue to be done virtually vs. on site. “Most patients will resist coming into the office unless they see the value to them individually as well as the altruistic attitudes we saw previously.”
The view from many is that the industry will never return to its previous normal, but rather to a new and improved normal, Johnston said. This could include:
- More acceptance of risk-based approaches;
- More acceptability — by study sites and patients — of digital tools and telemedicine;
- Adoption of more remote monitoring capabilities;
- More use of direct-to-patient drug and clinical supply shipments; and
- Greater use of virtual and decentralized trial designs.
“Technology will get better because there is more interest in it,” Johnston said, “but I really believe we are going to enter a hybrid world where some studies will go completely one way and others will be holding on to more traditional models.”
But work is still needed to successfully virtualize clinical trials, noted Jacob LaPorte, co-founder of Novartis’ BIOME program, such as how to design endpoints for a remote study. CROs that can’t adapt to the new approaches run the risk of being displaced, said LaPorte at the Eye for Pharma conference.
Getz said the crisis also has shown an enormous amount of 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.”
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.”
One of the biggest challenges facing clinical trials operating in a COVID-19 world is the frequently changing information coming out, which requires that researchers be willing to adapt quickly and be proactive with planning, Barrett said, noting that the pandemic has accelerated the need for sponsors to adapt their clinical strategies.
The final takeaway from the pandemic, according to Getz, is that sponsors and regulators 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.
Barrett also pointed to the newfound visibility that the pandemic has brought to the clinical trial industry as a potential benefit.
“Perhaps one of the unpredicted opportunities that has arisen from this is a greater understanding of the value and importance of clinical research and how the actions of a total stranger can have on a society when volunteering in a research study,” she said. “The industry needs to capitalize on this and continue to promote clinical trial awareness across therapeutic areas.”
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