By Benjamin Ross 

April 1, 2020 | The COVID-19 pandemic has left both pharmaceutical companies and researchers scrambling for continuity as clinical trials continue. Craig Lipset, former Head of Clinical Innovation at Pfizer, wanted to create a concise resource to support teams continuing their work. 

The result is Coronatrials.org, a site for researchers to find support in trial continuity, ranging from remote medication adherence and remote clinical monitoring to decentralized trial technology providers. 

“Clinical research is the ultimate shared economy,” Lipset told Clinical Research News. “We know that new study starts have been delayed and in many cases enrollment is being paused, but yet we need to keep investigational medicines accessible to enrolled participants and try as best we can to continue these studies.” 

Lipset created the list for both personal and professional reasons. Having worked at Pfizer and heading innovation for a number of years—and now being on his own—he has an opportunity to be a trusted intermediary in the space. “I’ve connected with so many on the research-sponsor side, the service provider side, the technology platform side, etc., but I don’t have any vested interest and so I can be an objective resource,” he said. 

The tools and resources listed on Lipset’s site are not full endorsements, he stresses. After privately discussing new solutions and options with companies and researchers, Lipset wanted to create Coronatrials.org to keep a running list of the results of those discussions. The list is malleable, he says, adding a disclaimer on the site that the list is for informational purposes only and that any content provided is “not advice or guarantee of outcome.” 

There are three main concerns when it comes to trial continuity during COVID-19, Lipset says: How do we keep the study drug in the patients’ hands, how do we ensure clinical and safety monitoring, and how do we maintain and support study visits in order to continually monitor patients and collect data. 

Lipset says the tools suited to address these concerns have always been available, though it’s taken the anxieties and limitations of COVID-19 to bring them to the researchers’ attention. 

“There are different solutions that were already being introduced in the market in each of these areas,” Lipset said. “Some work better at adoption than others, but in many cases there wasn’t a need to reinvent processes. For me, I think the challenge was, do people across the industry with their heads down trying to continue these studies know what resources are out there ready for them?” 

Lipset’s list features several resources for decentralized trials, as he says running clinical trials with flexibility from the clinic or from home is projected to be the future of clinical research. Resources such as Sanguine, IQVIA’s Virtual Trials, and in-home patient data capture platforms are built around a decentralized model. 

While these tools and resources highlight the innovation being done in the industry, Lipset says we can’t forget the patient perspective. 

“People who predict the [future of trials is entirely virtual] aren’t talking to patients,” said Lipset. “[Decentralized trials] isn’t the future patients are asking us for. When we sit and we talk and we listen, we hear that patients want flexibility. They want the ability to access a study on their own terms.” 

Lipset says we’re living this reality right now. Some of us are able to go to the grocery store, while others want their groceries delivered. “But just because we choose one option doesn’t mean we never want to go back to the other.” 

Patients want the same flexibility when it comes to trial engagement. 

“The goal should be to give the patients flexibility,” Lipset said. “And if we keep the patient at the center of this, we’ll get to our research goals as well. If we keep listening to patients along the way and not rush to technology and assume that that’s our salvation, we’ll be better prepared for the future.” 

A worst-case scenario would be a failure to shift existing portfolios of studies to more decentralized models of operation, which would result in their discontinuation, Lipset says. “If these studies have to terminate early, that’s going to have a material impact for sponsors, CROs, sites, and—most importantly—for patients that are waiting for these drugs to come through.” 

We’ve seen glimmers of this scenario begin to trickle into reality, with pharmaceutical companies like Eli Lilly delaying new study starts and pausing enrollment in a majority of their ongoing trials in the wake of COVID-19. 

For these postponed trials, Lipset says there’s an opportunity to engage with patients on a deeper level. 

“Now’s your opportunity,” he said. “To seize this gift of time that you have to gain additional insights from patients, to make sure that, when your study does go live that it’s going to go live the right way and not require you to stop once again for a protocol amendment because you didn’t account for patient considerations.” 

Lipset warns that not taking this opportunity to incorporate innovation into business practices long-term would be devastating as well. 

“If we learn nothing in terms of new approaches, does that make things worse than they are now? No, but it keeps us in the current state,” said Lipset. “If we fail to incorporate these tools when we’re on the other side of the curve and fail to make the changes in our organizations to adopt them more regularly, it doesn’t make us a resilient industry. It just sets us up to be exactly where we are today when the next pandemic comes.”