By Matthew Moyer, director, clinical supply technology, Merck
Patient-facing digital technologies — also referred to as patient technology (PT) — have the potential to make a significant impact on the clinical research environment. PT includes any digital technology patients interact with to participate in clinical trial activities. When implemented effectively, these technologies can enhance patients’ experiences and engagement, streamline clinical trial processes, and enable better, more robust data collection in clinical trials.
Despite gains in the everyday healthcare industry, the adoption of PT as a mainstream tool remains limited in the clinical research and pharmaceutical realms. Although PT has the potential to serve a variety of functions in clinical studies, such as capturing clinical endpoints, engaging patients, and facilitating remote study conduct, many trials continue to rely on manual or traditional methods. As a result, the lack of fully characterized opportunities, challenges, and facilitators associated with PT implementation has prevented the realization of benefits PT may bring.
To help understand the factors affecting PT adoption, the TransCelerate Patient Technology Initiative conducted a series of surveys, interviews, and focus groups with approximately 600 subject matter experts, including TransCelerate member companies representing sponsors, clinical trial investigational sites, and clinical trial participants. Specifically, the results provided valuable insight into the unique challenges that are preventing wider implementation of PT in the clinical trial ecosystem and how we can overcome them.
Here are a few of the primary barriers we identified from the survey, which can be used to help inform actionable model solutions that can facilitate future PT adoption:
- Change Management
A top-cited organizational challenge was related to a risk-averse corporate culture. Due to pressures to adhere to complex regulatory requirements, sponsor organizations have developed a general hesitancy to embrace change and implement PT. Survey respondents also mentioned that a lack of corporate strategy, leadership, and vision, along with limited communication across functions, has hampered progress. Overall, there was consensus that a clear articulation of reason and a distinct plan of action are needed for corporations to be willing to accept change.
- Investment Risks
While the goal of PT deployment is to enhance the science-related conduct of clinical trials and facilitate patient recruitment and retention, those improvements require significant up-front investment. Consequently, technology cost was the most commonly cited business challenge among site and sponsor respondents, with the added notion that the expected return on investment was also relatively unclear. These financial implications make it difficult for senior leadership to see past the near-term impacts on budget and visualize the long-term ROI.
Changing the mind-set from short-term return to long-term outcomes may take a multistep process, which could include: First, articulate the timeline for recognizing benefits of PT uptake, such as receiving a better signal that a trial will result in a potentially good outcome. This speaks to the language of return for business leaders and can easily offset the up-front investment. Second, inform leadership that PT implementation could help magnify the pool of potential trial participants, thereby increasing recruitment rate and helping patients benefit from a therapy more quickly. Third, take a pilot approach, and provide sponsors a framework for scaled deployment of technology implementation. This way, sponsor companies have the option to experiment with PT in a way that doesn’t impact a clinical trial team and can then progress to broader application.
- User Experience
We also received insightful information regarding the willingness of sites and patients to use PT, as well as the primary barriers they face with adoption.
From a site perspective, most reported that PT increased their desire to participate as a site (28.5 percent) or did not impact it (65.6 percent). Similarly, member company respondents agreed or strongly agreed (61.1 percent) that sites were generally willing to use PT in clinical research.
Despite sites expressing a willingness to use PT, a predominantly cited obstacle is the difficulty of managing patient training and experience and accessing the right tech support. It was also noted that sponsors need to better understand the impact PT adoption may have on sites, suggesting they should engage with sites to manage expectations and ensure they understand the potential value of PT.
In light of this feedback, TransCelerate recently developed a Patient Technology Implementation Framework outlining a possible approach to PT implementation and encouraging a mind-set of strategic thinking, rapid learning, and patient-centric design.
Comparatively, from a patient point of view, most felt there is no one-size-fits-all approach to the use of technology in clinical trials. Patient respondents suggested that the acceptability of and access to technology should be considered when designing a clinical study with PT and that technology should not replace all in-person trial interactions.
Interestingly, site and sponsor participants had differing perspectives on the patient experience with, and willingness to use, PT. Although sponsor and site respondents agreed that patients were ready to use PT, sponsors tended to believe that PT positively impacts the patient experience, while sites were more likely to report that PT use increased patient burden.
Sites and sponsors did agree on the key challenges that patients face with technology, such as access to connected devices and the time, effort, and complexity associated with learning to use the trial’s technology. In partnership with TransCelerate’s Patient Experience Initiative, we’re working to reduce these burdens and develop tools that engage patients and increase patient-centricity of study programs.
- Uncertainty And Variations In Regulation
Regulatory implications were reported as another major barrier to PT adoption. One main challenge includes the lack of specific regulations or guidance around PT in clinical trials — both in the U.S. and worldwide. The absence of specificity, as well as variable interpretation, makes it especially difficult. Moreover, what regulation does exist is often misunderstood or overestimated by sponsors.
To help sites and sponsors navigate this ambiguity pertaining to PT, we’ve developed a Regulatory Landscape Tool. We’re also actively identifying where additional regulatory gaps exist so we can engage regulators around those gaps and ultimately help with PT deployment.
While there’s a growing interest for using PT in clinical research, full implementation will not happen overnight. It’s going to require a cross-industry effort to advance awareness, but PT offers us an exciting opportunity to improve our understanding of investigational drugs, improve patient engagement and study experience, and ultimately have a positive impact on all stakeholders in clinical trials.
About The Author:
Matthew Moyer is director of clinical Supply Technology at Merck. With more than 18 years of pharmaceutical development experience, he leads Merck’s global clinical supply innovation efforts, incorporating new digital and enabling technologies to drive improved clinical trial execution and more informed and rapid decisions. Matt also leads the TransCelerate BioPharma Patient Technology initiative, aiming to accelerate the use of patient-facing technologies to improve the science and convenience of clinical trials. He earned a BS in chemistry from Albright College, an MS in pharmaceutical sciences from Temple University, an MBA from Lehigh University, and is certified in Project Management (PMP).