By Thomas Cocciardi, LMK Clinical Research Consulting
When COVID-19 started to impact our communities, what happened next exemplified the commitment and passion of TMF professionals, clinical researchers, and the pharmaceutical industry as a whole. Across the industry, clinical trial stakeholders united through innovative technology to carry the torch of research forward again. Working long hours and persisting through crushing uncertainty, our initiatives were reinvigorated, our way of working was reshaped, and our industry’s culture was reimagined. A survey by Arkivum found the initial disruptions of COVID were massive: 74% of respondents felt that COVID had negatively affected their organization’s ability to deliver clinical trial objectives, but of those same respondents, 70% said the pandemic presents a new opportunity for changing the way clinical trials are conducted in the future1. In other words, these respondents confirm a phenomenon we see unfolding around us: because of COVID, digital transformation has finally arrived in the clinical trial industry.
Now, as the United States enters the fortunate possibility of a summer characterized less by COVID and more by time spent with family and friends, we can begin to recount our harrowing journey. But are we willing to face COVID’s hard lessons? And are we committed to securing COVID’s potential gifts?
Digital Transformation Is An Ongoing Pursuit
At its core, digital transformation is the adoption of technology to replace manual processes and achieve a benefit like increased efficiency, market share, compliance, or profitability. Under the wide umbrella of this definition, digital transformation encompasses several ideas, values, and concepts related to the intersection of new technology and industry. Digital transformation can specifically refer to process improvement, such as, for example, the replacement of the paper TMF with an electronic trial master file (eTMF). Digital transformation can also imply technology-inspired change in other domains, like the disruptive business model transformation of Blockbuster by Netflix or the cultivation of a pro-technology business culture.
A process-focused digital transformation in the clinical trial space was well underway before the rise of COVID with the growing adoption of purpose-built eTMF platforms to replace paper TMFs. According to the Veeva 2018 Unified Clinical Operations Survey, 66% of respondents had adopted an eTMF system by that year.2
In the Veeva 2020 Unified Clinical Operations Survey, conducted as COVID case counts were first rising, eTMF adoption had risen to 78%.3 When asked in 2018 about the primary drivers of eTMF adoption, respondents cited improved inspection readiness (70%), better visibility (61%), and improved collaboration across study partners (42%). These drivers of digital transformation in the TMF, however, shifted significantly in the 2020 survey, which was conducted during COVID’s rise in the United States.
While many of the 2018 drivers were still considered important, an astounding 100% of respondents to the 2020 survey said they needed to improve information sharing (i.e., collaboration) between study partners to reduce manual processes. While one could argue the unanimous desire of participants to improve collaboration was wholly the product of short-term COVID-related disruptions, such a powerful signal from respondents cannot solely be attributed to temporary factors. If the digital transformation of eTMF adoption was a foregone success before COVID’s arrival, one would have expected the priorities of respondents to shift away from concerns about manual processes.
During COVID, however, the opposite trend was seen and the first hard lesson of COVID was taught: TMF stakeholder pain regarding collaboration and manual processes was growing even as eTMF adoption had become the norm. The industry-wide focus of eTMF adoption, a process-focused digital transformation, did not fully realize its anticipated benefits. COVID’s disruptions to the traditional clinical trial business model in areas such as protocol execution, site/patient interaction, and site/CRO communication and compliance had a cascading effect on TMF health. Facing rapidly evolving challenges to trial conduct as a result of impeded site, patient, and CRO interaction, many documents did not reach the TMF or were incomplete, lost, misfiled, or not generated at all.
It seemed that if the promise of digital transformation were to be realized in the TMF, the business models and corporate cultures supporting eTMF processes needed their own parallel transformation. Ultimately, the pressures and restrictions of COVID provided industry the incentive to support eTMF process-related digital transformation with other kinds of change.
Suddenly, as offices and sites closed, there were no coordinators to call, monitors to email, or CRO specialists to meet face-to-face with. Documents were left stranded on desks, in filing cabinets, and in binders. So how did clinical trial stakeholders respond? After the initial shock disruptions, professionals turned to the underutilized technology already available to them. Existing eClinical platforms were finally integrated fully into business processes, allowing access to information without the need to physically congregate.
The Shift Of eTMF Into A Fully Process-Integrated Tool
Perhaps the most notable transformation of existing eClinical technology to adapt to COVID was the shift from using the eTMF as a retrospective repository to using it as a real-time fully process-integrated collaboration tool. Before COVID, the traditional business model produced many unavoidable barriers to truly contemporaneous filing. Sites and CROs struggled to overcome the habit of hoarding documents for filing only at the close of the trial. After all, it was easy enough to gain information about the trial through other channels when everyone was in the office. COVID forced stakeholders to contemporaneously file eTMF documents to achieve any kind of visibility of the trial’s status. The alternative was complete discontinuation of the trial.
From this newfound eTMF visibility flowed solutions to most other significant COVID disruptions: Remote monitoring became feasible. Protocol amendments could be collaboratively authored, signed, approved, and disseminated remotely from the eTMF. With all aspects of a protocol amendment tracked in the eTMF and available to all stakeholders, anticipating and managing the real-world impact of COVID on trial conduct were greatly simplified and sponsor oversight and inspection readiness were once again achievable.
These eTMF-enabled, COVID-inspired digital transformations, though, were only possible thanks to stakeholder willingness to rethink a business model outmoded by COVID. Simply put, COIVD provided stakeholders the freedom to reimagine the old way of collecting and distributing information with the technology already at their fingertips. But why did it take a pandemic to fully realize the potential of the eTMF and other eClinical technologies? The source of this change lies in perhaps the most important domain of digital transformation: cultural change.
The New Culture-Led Clarity On eClinical Systems
In the 2020 Veeva Unified Clinical Operations Survey, 98% of respondents identify the need to unify clinical systems, and 83% had some kind of unification initiative underway. Stakeholders craved this unity in response to the exploding variety of eClinical systems that were often not used as intended or used in parallel with the hidden, unofficial systems users preferred (mainly Microsoft Office and email). The burden of gaining access to, training on, and maintaining dozens of platforms had monopolized the time and attention of the clinical trial stakeholder and had begun threatening trial performance. When COVID arrived, the fragmented nature of eClinical systems only intensified as stakeholders found these supposedly collaborative systems inaccessible and disorganized.
While it is tempting to blame the problem of too many eClinical systems on the quality or performance of these systems alone, it is worthwhile to consider what aspects of clinical research culture inspired the creation of so many eClinical systems in the first place.
Pre-COVID: An over-proliferation of eClinical systems.
The over-proliferation of eClinical systems reflects the outsourcing business model of clinical research and the specialist culture that has developed within it. Because clinical research is complex, no one person can manage all aspects of a trial. In addition, because stakeholders are spread across time zones, professional and scientific disciplines, and organizations, it can be difficult to maintain visibility between specialties and operate as a combined team. As a result of these barriers, knowledge became siloed within these isolated groups, and the many specialties of clinical research culturally adopted an inward-looking gaze.
The new norm: COVID finally forced the industry-wide realization that information silos put trial performance at risk and negatively impact all trial stakeholders. From this realization, the democratization of clinical trial information became less threatening and the effort necessary to extend a hand across the aisle became more worthwhile.
Pre-COVID: A lack of unity of systems.
Because of the specialist culture and in-group favoritism, eClinical systems were developed separately as each isolated group modernized at different times and in response to different factors. The prevailing culture ensured it was easier to build and implement systems focused on the problems of one professional community than to try and find common needs between teams.
The new norm: COVID showed that most stakeholders had similar needs and desires that were still unmet by the dozens of existing eClinical systems. Coupled with improving eClinical technology and a renewed focus on user experience, the cultural belief grew that unity of systems was both desirable and achievable.
Pre-COVID: A risk-averse culture.
Legacy eClinical systems were hampered by the risk-averse culture of clinical research. eClinical systems face a constraint not present in other less-regulated industries. System design must conform with decades-old regulation that was written before many modern technologies existed. As a result of the tension between user experience and regulation, eClinical systems often digitized manual processes instead of automating them or eliminating them altogether.
The new norm: With the rise of COVID, it became clear that there were real risks associated with stagnation as well as change. If industry culture was less-risk averse, an earlier and more complete integration of eClinical technology might have lessened the impact of COVID on many clinical trials.
But as these promising digital transformation-inspired cultural changes drive clinical trial stakeholders to rethink their contribution to clinical research and break through self-imposed limitations, one key question remains: When COVID is over will the changes stick?
Digital Transformation Is Here To Stay
COVID did not magically fix all the problems of clinical research. Some will righteously point to their own challenging COVID stories, noting that the downstream effects of the disruptions continue to compound and that clinical trial stakeholder burnout remains a real threat. The pandemic is not over for most. Yet, we can all agree that change came to an industry that had been resisting change for decades. In fact, a recent poll of 482 readers of Pharmaceutical Technology found that 30% of respondents felt that COVID-19 had accelerated digital transformation in the pharmaceutical industry by more than six years, and 60% responded that they felt that the digital transformation was accelerated by more than two years.4 This change, of course, was the product of massive disruption. But change, no matter how chaotic, is ultimately a creative force. Clinical researchers rose to the occasion in this time of crisis because our industry is more important and more relevant than ever. Technology is a persistent, dispassionate, and eroding force. It cannot be stopped. If we fail to continually remake our processes, business models, and culture, we will soon be swept downstream into irrelevancy. But, if we harness the power of technology through digital transformation, we will all gain new momentum toward achieving our shared mission: to bring new hope to the patients that need it most.
About The Author:
Thomas Cocciardi is a technical writer at LMK Clinical Research Consulting who is committed to expressing the human story behind each TMF. He also works as a medical writer. Cocciardi has gained wide-ranging experience, both in and out of the pharmaceutical industry, as a regulatory writer, TMF-focused clinical trial associate, TMF health specialist, and clinical research coordinator. He holds an M.S. in regulatory affairs from Northeastern University and the RAC (US) credential.