COVID-19 and a Future with Fundamental Design Shifts: Incorporating Virtual into Clinical Trials
By Kathleen Hoffman, PhD, MSPH
On a recent Pharma Talk Radio podcast called, The Impact of COVID-19 on Clinical Trials: Where are We? And Where are We Going?, three subject matter experts discussed how they see COVID-19 impacting the future of clinical trial research. What needs to change?1
The experts were Ray Dorsey, MD, the David M. Levy Professor of Neurology and Director of the Center for Health & Technology at the University of Rochester; Matt Kibby, President and Principal of BBK Worldwide; and Craig Lipset, the founder of Clinical Innovation Partners and the former Head of Clinical Innovation and Venture Partner at Pfizer.
Telehealth and Virtual Visits
One of the fundamental changes brought about in the pandemic is the move to telehealth and virtual visits. As Ray Dorsey put it,
…in 2 months we have seen more innovation in healthcare delivery than we have in 2 generations. We saw telemedicine go from …less than 1% of all visits to 60% of all visits in less than 2 months. I think we are at the cusp of seeing something very similar happen to clinical trials… we are going to see rapid adoption of virtual research visits into studies right now.
Yet because most clinical trials depend on on-site visits, many trials are presently stalled. A recent Inspire survey on the impact of COVID-19 on the health care experiences of chronically ill Inspire members showed that over 95% of the survey participants currently participating in or registered for a clinical trial described their trials as cancelled or postponed, with the remaining few having dropped out completely. According to research done by Inspire’s qualitative team, some members have even petitioned the NIH and Stanford to continue registrations because patients have the greatest dependence on advancing research. As one member put it:
I am in treatment for metastatic…cancer that entailed removal of my…kidney. I should be getting ct scans every 3 months. I’m also in a clinical trial for a immunotherapy drug [NAME OF MEDICATION]. I’m unable to get a ct scan or participate in the clinical trial due to COVID 19 now.
The podcast speakers characterized the sudden rush to telehealth as having gotten large organizations beyond talking about virtual care theoretically to actually implementing it. However, as Craig Lipset pointed out, all of this change has been in the form of short-term solutions:
[This spring] everybody was focused on just making the studies sustain, avoid missing doses, avoid missing data. And in the scramble — that was done with SOP waivers and protocol deviation — because that’s how we do it when we’re in a rush. Now it’s this question about sustainability: are organizations really going to commit to this change? This is not the new normal unless people commit to making it the new normal.
Future of Clinical Trial Design
According to Lipset, much work needs to be done, including revising procedures, changing vendors, retraining both internal and adjacent staff, changing how sponsors fundamentally design protocols, and creating new methods for data acquisition, among others. “We have to make sure we have accounted for endpoints that are location flexible, endpoints that don’t care if we’re measuring in the clinic or in the home. Without that early investment in planning, we’re locked into… forcing patients to travel to a clinic to measure things that we know we can measure in better and smarter ways, using new digital [instruments].”
He believes that clinical design will eventually change into a hybrid model, with part of the work being done in a more patient-centric model, and with other aspects being conducted in a face-to-face format “as it makes sense.”
Chronically Ill Patients Need Support, Flexibility
Lipset and Dorsey specifically addressed the barriers that current clinical designs impose on chronically ill patients:
Lipset said, “There [are] people with rare diseases and more serious conditions, more serious than COVID-19, that required support to be able to go into their sites… So we’ve been seeing a lot of requests for medication delivery, the ability to reassign sites, the ability to do more consenting, or providing more engagement to people when they are waiting between visits.”
Dorsey agreed that clinical trial design needs to change simply to succeed. “I think the failure to commit [to fundamental changes] will be risky,” because current site-centric design fails to meet the particular needs of the populations they’re researching. “[My study volunteers] are generally older individuals, many are obese, many have hypertension, many have diabetes, many have compromised respiratory function. …most clinical trials take months if not years. Unless you commit to decentralized studies, at least as an option, you’re exposing yourself to a huge amount of risk.”
Improved Data Quality
Matt Kibby pointed out that the biggest concern of most sponsors is ROI. Will the work needed to redesign how trials are conducted be worth the investment? When clinical designs rely more on portable technologies and in-home devices to collect data, Dorsey said, “I think we are going to find out that these are far more sensitive, generate far better data that’s objective and reflects what’s happening in the real world than our traditional rating scales.” Lipset added that this is not a “someday” aspiration: “All the tools that are needed to enable decentralized research are being proven, right now, every day.”
Dorsey supported this assertion with an example, “We just need to learn how to conduct clinical trials around the world. Craig [Lipset] showed us how to do this 10 years ago, we just need to apply those lessons and techniques for doing it in this world. We’ve connected to over a thousand people with Parkinson’s disease and a wide range of other neurological conditions over the last 8 years in 40 different states for 5 different neurological conditions with these research studies.”
“Perhaps most importantly, protocol authoring needs to be rethought,” said Lipset. “when we are developing our clinical development plans for [a] molecule, when we are mapping out over the next few years what studies we are going to be doing and what endpoints we are going to be measuring, we have to make sure we have accounted for endpoints that are location flexible.”
Experts can learn from Inspire members with chronic illnesses who already know the shortcoming of virtual care. In June, Inspire presented the webinar How has COVID-19 impacted chronically ill patients? Patient Reported Outcomes from Social Distancing and COVID-19. Based on mixed-methods research, the webinar described some of the impact the pandemic had on real patients in clinical trials and described the problems that arise for chronically-ill people when telemedicine is implemented quickly and precipitously.
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