Trials Industry to Focus on Patient-Centricity in Next Phase of Pandemic, Executives Predict
The future of trials depends on a focus on patient-centricity as the industry moves past rapid adoption of novel trial designs and technology that aids in decentralization during the COVID-19 pandemic, industry experts named to the PharmaVOICE 100 for 2020 forecast last week.
“The world is completely upside down,” Donald Deieso, CEO of WCG Clinical said, referring to changes the industry has made in the face of the COVID-19 pandemic. “What we have always done and how we have always done it is irrelevant. The only constant is why we do what we do.”
In addition to being named to the 100 list, Deieso won a Red Jacket Award, PharmaVOICE’s “hall of fame” for individuals who have been named multiple times to the list of 100 influential people in the pharma industry.
Approaches that include decentralized trials and digital technology to support remote monitoring have been shown to be effective in keeping trials operating during the pandemic along with broad patient approval of these approaches. That likely means a shift to more hybrid studies that are “location agnostic” and allow patients to choose the path — virtual, in-person or a combination, for instance — that works best for them, Craig Lipset, founder of Clinical Innovation Partners, said during a panel discussion at the conference.
Lipset cautioned against just forging ahead to scale up solutions that have worked in recent months to keep studies going. The focus has been on trial continuity during a pandemic, he explained. While there is opportunity for greater patient engagement in the approaches taken, study teams will need to pause and talk with patients to make sure they are offering truly patient-centric options.
Going forward, the industry needs to step out of the crisis mindset and commit to real change, Lipset said. That means investing in SOP reviews, training, new vendors and partners for new operating models, along with changing how protocols are written and how researchers interact with patients.
“We mustn’t lose sight of the intersection between decentralized research and patient-centricity,” he said, noting that research needs to include patients in even the earliest study conversations to make sure that studies are providing what they want and need, not just what available technology can deliver. “What we most often hear from patients is that they want choice. They want options in how they participate [in clinical research], not just to have us replace one option with another.”
Nancy Dreyer, chief scientific officer and senior VP of real-world solutions at IQVIA, is cautiously optimistic, noting that while different types of clinical trial designs are being accelerated, it remains uncertain that this change will be sustainable.
“It’s got legs and will keep going,” said Dreyer, who also won a Red Jacket Award this year, “but solving all the world’s issues so we can get drugs delivered to the right place is the holy grail, not a near-term fix, but a laudable goal.”
Deieso suggested that demand for change from patients and consumers makes it more likely that positive changes will continue. Public pressure on the industry and regulators to adopt methods that include more patient input and make it easier and more productive for patients to participate in trials can help ensure that the changes made so far are sustained and built upon, he said, adding, “Keep a little optimism for what the consent of the public can do.”
“Different types of clinical trial designs are being accelerated as companies and regulators realize things need to be done differently,” Amir Kalali, chief curator and chairman of CNS Summit, agreed. “Younger patients are different from people our age. They are not going to put up with the kind of stuff we did,” meaning the younger study populations are more likely to demand flexibility in how they participate in clinical trials.
Technology, the experts agreed, will continue to play an ever-increasing role in both decentralization of research and patient engagement. Digital technology that allows virtual visits with research associates or healthcare providers has been critical in allowing studies to move forward under COVID-19, and appear to improve patient engagement, as well.
“Technology plays a key role in our daily lives,” Jessica Kim, creative director, patient experience and engagement at BBK, said in an interview. “It makes sense that incorporating technology into clinical studies would enhance patient experience. Technology can help integrate clinical studies into a patient’s everyday life.”
A key to successful integration of technology into clinical research is to ensure that the tools provided to patients are as user-friendly, meaning they are as intuitive and easy to use as the technology that patients use in their daily lives for scheduling, social engagement and work.
Michelle Longmire, co-founder and CEO of Medable, suggested that a single digital interface that allows connection with patients from recruitment through the end of a study could aid in patient engagement. This approach could enable research anytime and anywhere, as well as ensuring patient involvement from the beginning, she said in a prerecorded interview.
But use of digital technology and development of protocols and processes that accommodate such use are not the only important features of future clinical research.
Kalali, for instance, stressed the importance of empathy for pharma leaders. Empathy — not only for patients, but also for researchers, hospitals, regulators and others having to deal with rapid and dramatic changes in operations — is the foundation of other critical measures, including team building and collaboration, he said.
Ensuring the right work environment is one of the biggest challenges the industry will face going forward, Deieso said. That environment must encourage collaboration, closely related to empathy and team-building.
Cheryle Evans, senior vice president of North American operations at Advanced Clinical, also forecast that the complexity of protocols and study designs will continue to grow. For instance, more protocols are now looking at multiple indications, resulting in adaptive study designs or basket designs, in which different subgroups are identified within a patient population and placed into cohorts or “baskets” for the study.
More protocol amendments are also being seen, which require more mid-study updates. That means that interdepartmental teams need to act more cohesively together to address those changes, as well as any mitigations that may be needed, Evans said in an interview recorded for the event.
Growing use of real-world evidence (RWE) is also likely, some of the award winners suggested. For instance, Dreyer, in a prerecorded interview, suggested that RWE should be considered as the bookends to clinical research.
“RWE is where we get our ideas, where we identify unmet needs or problems to be solved,” she explained. “And then, we used exploratory analysis using the RWE, conduct a trial and again go back to the real world to see if our findings hold up.”