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Affirming and advancing patient engagement and digital transformation.
Throughout the pandemic, clinical research stakeholders have been both amazed and immensely proud at the collective effort to adapt and address a monumental global health crisis in record time.
A great deal has been written and said about the factors that have contributed to the delivery of COVID-19 vaccines more than five years faster than typical development timelines and to the more than 1,000 COVID-19 treatments and vaccines now in the pipeline. The top contributing factors include:
The clinical research enterprise has much to celebrate, especially in light of the fact that most adaptations and changes represent a major departure from normal operating conditions. Many of the approaches and solutions deployed—such as remote monitoring, e-consent, home nursing visits, and integrated data management platforms—faced significant difficulty replacing legacy approaches before the pandemic. Many were stuck in planning or piloting stages for decades.
There is now substantial speculation about how the clinical research enterprise will function when the pandemic is fully behind us. How will the enterprise apply and embrace the experiences and lessons learned during this unprecedented period? Beginning in late 2020, articles, podcasts, webinars, and conference presentations began surfacing, most with both wishful thinking and pledges not to return to pre-pandemic operating conditions.
In recent months, we have learned more about underlying conditions that have supported pandemic response and a clearer picture is emerging of issues and challenges that will contribute to some retrenchment and more conservative application of adaptive and innovative practices as we move into a post-pandemic world. Two recent Tufts Center for the Study of Drug Development (Tufts CSDD) studies help paint that picture: the first study is an in-depth collection of interviews with principal investigators and senior study coordinators from the global community of investigative sites and site networks. The second study is a global survey—conducted in collaboration with the Bill & Melinda Gates Medical Research Institute (Gates MRI).
Tufts CSDD conducted a total of 26 in-depth interviews during March and April 2021, approximately one full year after the international community began locking down and clinical trial activity abruptly shifted to remote monitoring and decentralized support. Investigators and study coordinators noted several positive outcomes. The majority pointed to sponsor company and regulatory agency responsiveness and encouragement of adaptive practices as critical success factors. Site professionals felt that the most positive outcome in the transition to virtual and remote clinical trials has been the increased choice and accessibility offered to patients considering participation and the substantial improvement in study volunteer convenience.
But with few exceptions, the global community of investigators and study coordinators indicated that operating remotely and virtually has greatly increased workload for site personnel. Many noted the inordinate amount of time they have dedicated to learning new technology solutions; providing support to remote monitors and health professionals; training vendors unfamiliar with the clinical research process; and coordinating and integrating disparate and fragmented activities. Most interviewees pointed to significant delays that they have encountered starting up studies, receiving clinical trial supplies and lab kits.
Many conveyed concerns about the delays they experienced in receiving payments to help defray the substantial upfront risk sites assumed in supporting modified and adapted execution models.
In nearly every in-depth interview, investigative site personnel discussed the wide variability in approaches and solutions deployed by sponsors and contract research organizations (CROs) that contributed to high levels of uncertainty and the increased potential for errors and mistakes.
Between mid-January and April 2021, Tufts CSDD and Gates MRI gathered 344 global responses primarily from pharmaceutical, biotechnology companies, and CROs. The purpose of this online survey was to assess the experiences and effectiveness of development teams operating remotely. Two-thirds of respondents are employed by major and mid-sized companies and a similar percentage reports having team management responsibility within clinical, data management, and clinical operations functions.
Overall, respondents reported very high levels of productivity while operating remotely. Nearly all (97%) indicated that they can perform their role as a remote employee “very effectively” or “somewhat effectively.” But more than half of respondents (55%) report feeling burned out and 42% report that connections with their colleagues have deteriorated.
Factors contributing to burnout are intuitive and generally familiar to us all. The top three included the frequency of virtual meetings (by 67%); increased workload and additional responsibilities negatively effecting life balance (65%); and the emotional impact of dealing with uncertainty and isolation (54%). Unaddressed, it is likely that the feelings of burnout and loss of connection will continue to rise.
In open-ended responses, several indicated that the inability to travel and meet face-to-face with colleagues detracted from their collaborative effectiveness. Several also noted the challenges of not having a clear sense of the return on investment (ROI) for various solutions deployed and of the higher relative start-up cost and time investment required to support decentralized clinical trial activity.
Despite these experiences and concerns, the vast majority of respondents want to preserve their ability to operate remotely: 86% want their employer to continue offering “mostly remote” work when the pandemic is over; 6% indicate that they are uncertain about what operating model they want in place; and 8% said that they do not want their organizations remote operating model to continue.
We plan to publish the full results of the Tufts CSDD–Gates MRI study in Applied Clinical Trials this summer.
Pandemic experience and response has exposed drug development organizations to numerous possibilities that would not have otherwise been widely adopted. Many observers would argue that this unusual adoption experience is not a reflection of a new standard operating environment but rather a one-time occurrence—a grand pilot program—providing a unique opportunity to consider, integrate, and apply “suitable” new options and choices.
Once the pandemic is behind us, these options and choices will likely be offered simultaneously with other more traditional approaches to balance and best satisfy study volunteer preferences, convenience, and scientific and operating requirements. Ultimately, these more expansive hybrid approaches will increase clinical trial complexity and customization, resulting in well-known outcomes: inefficiency, poorer quality, slower timelines, and higher costs.
Given cultures that have historically been risk-averse and resistant to change, many sponsor companies and their CRO partners will step-up efforts to scrutinize capital, personnel, and resource investment in, and double down on challenging, newer innovative practices. For the majority of organizations, it is likely that the pendulum will swing back toward slower, more measured response and more
A minority of organizations—those willing to take more risk—are already applying the implications of pandemic experience. Many are evaluating ways to better support teams operating remotely with more variable, agile, and flexible staffing models, infrastructure, and standard operating procedures. Several have shared the intent to consolidate their fixed, physical operating footprint, to continue to reduce study participant burden, and to entertain more open collaboration models.
Clinical research data volume has been rising dramatically for decades as protocol design objectives and scope have increased. The diversity of sources for clinical research data—including specialty labs, mobile and wearable devices, and patient health records—has also intensified. Post-pandemic, the juggling of highly customized clinical trial executional models will drive the collection of more data informing operating performance, efficiency, and quality. This rapid expected growth in rich data volume cannot be managed by traditional means alone and will rely more heavily on sophisticated and augmented analytics, including machine learning, risk-based quality management, and risk-mitigation techniques.
As the pandemic recedes and we gather more robust data on its full impact, we can anticipate wider variation in sponsor, CRO, and investigative site operating strategies and practices.
We will look back at our collective response with not only amazement and pride but also the knowledge that the pandemic did not solve our perennial drug development operating conditions. Rather, it necessitated experiences that affirmed, informed, and elevated enterprise-wide commitment to patient engagement and digital transformation.
Reach Ken Getz via email at firstname.lastname@example.org