Due to COVID-19 the clinical trial industry has been adopting advanced clinical trial technology at warp speed, but what does this mean for the future? What is a sustainable approach to ensure the industry does not face the same challenges and delays should we be impacted by another pandemic or global crisis? In this podcast we sit down with Mary Mattes, Senior Vice President of Global Operations at Synteract to discuss decentralization of clinical trials and a hybrid model.
Senior Vice President of Global Operations | Synteract
As Senior Vice President, Global Operations, Mary is focused on the quality delivery of clinical operations, data management, biostatistics, regulatory affairs, safety, and medical writing services globally. With experience in project management, data management, and analysis, Mary defines and develops her teams to meet the demands of today’s clinical research environment. Applying her 20 years of experience in technology and regulatory requirements for Phase I-IV trials, Mary also partners with the Synteract leadership team to select and implement technology to enable the success of the company.
Previously Mary was a member of the executive team at Accelovance, where she led both their biometrics and information technology functions globally. Prior to that, Mary held a variety of positions of increasing responsibility in the biometrics functions at PRA Health Sciences.
Chief Operating Officer | Medrio
Christina Hughes is the Chief Operating Officer of Medrio. Christina has over 20 years of experience in the clinical trials industry focused on delivering high quality solutions through the innovative use of technology. Prior to joining Medrio, Ms. Hughes held executive positions at Bracket (now Signant Health), AiCure, and ERT. Ms. Hughes holds a BS from Yale University and an MBA from University of Pennsylvania’s The Wharton School.
On COVID-19 waves and how to best ride them for clinical research trials. [3:30]
I think there’s the initial piece where first and foremost, we were focused on the safety of our employees then moving into making sure that the safety of our patients that were on the trials that we were involved with were paramount. So figuring out how to navigate site closures, how to navigate patients unable to get their investigational product, navigating how we could still stay in touch with patients that were actively taking whatever test articles were under study, trying our best to help preserve these studies and trials for our sponsors, figuring out what we could do, moving certain things to virtual platforms and ways of continuing to run the studies, but also helping then as time went on to come up with strategies of making up for lost time.
In the wake of COVID-19, how is Synteract equipped to support a decentralized or hybrid trial? [7:20]
We have quite a few studies that midstream started implementing things like direct patient outcome reporting, moving to the data collection from being collected at a site visit to actually moving it out into some kind of an eCOA tool where patients were being able to provide that. We also had experience on active studies that we were running during COVID where we scaled up mobile nursing solutions.
On the top three reasons why a sponsor should decentralize or implement a hybrid clinical trial, Mary lists this as her number one: [10:30]
I think there is a tremendous potential here to truly realize that patient accessibility piece that I think we talk a lot about in this industry, but for whatever reason we don’t quite step into it. The idea of that patient accessibility is there, but truly creating an environment where patients are being driven to the trial directly, I think is something that’s been a lot more talk than action by many sponsors and CROs and even technology providers in the industry.
Where do you see the industry heading in general and then as it relates to technology. [12:45]
I think that the industry is thinking in a whole new way about resilience. I think we need resilience in study execution. We would need resilience in product delivery, in how we move products through a life cycle and being able to respond as these changes evolve.
Do you see a hybrid model or decentralization as being a short-term solution or a long-term strategy? [15:30]
I think we’re in a really fun proof of concept time where we all really know the contours now of this landscape, the kind of challenges that we face in accessing these patients and keeping these trials viable and alive and moving swiftly through development to be able to deliver those treatments that are awaiting.