In the rapidly evolving realm of clinical trials, understanding the challenges and opportunities presented by new technologies is crucial. We delve into this intricate world with Wendy Tate, Director of Advanced Analytics and Research Optimization at Advarra, exploring the findings of a recent market research survey. We discuss the nuances of the study activation process, the disparities in eConsent adoption, the myriad of technological platforms coordinators juggle, and the hopeful promise of emerging engagement tools. Wendy, with her rich experience in academic medicine, offers unique insights into how the landscape has changed, the challenges that persist, and the potential solutions on the horizon. This dialogue provides a comprehensive overview of the complexities research sites face and a hopeful outlook on the future of streamlined clinical trials.
Moe Alsumidaie: Can you share insights about the survey and its primary objectives?
Wendy Tate: For this market research survey, our primary aim was to engage with sites and discuss the study activation process. We’ve previously conducted similar inquiries, but we’ve tailored our questions over time, keeping pace with the evolving nuances of clinical research. Study activation is foundational to Advarra’s mission, and we’re dedicated to initiating research that’s safer, more efficient, and expeditious. My 15-year tenure in academic medicine gives me an intimate understanding of the challenges sites face during study activation. We are passionate about streamlining the process, leveraging technological tools, and ensuring productive research by fostering close collaborations with participants.
Moe Alsumidaie: Why is there a noticeable disparity in eConsent adoption rates, with a mere 14% of sites adopting it, while sponsors and CROs offer eConsent for 75% of their studies?
Wendy Tate: eConsent is increasingly becoming vital, especially in decentralized clinical trials that aim to penetrate deeper into communities. Some key facets to consider include:
- IRB Engagement: Our interactions with IRBs frequently revolve around the presentation of the eConsent process. The emphasis is on maintaining the sanctity of the informed consent process in its digital avatar. The overarching concern is to ensure potential participants are thoroughly acquainted with their involvement.
- Operational Challenges: Operationalizing eConsent isn’t simply uploading and disseminating a consent form. A significant collaborative effort is required from both the sponsor and the site to ensure its efficacy.
- Content of Consent Forms: Despite aspirations to keep consent forms in layman’s terms, we’re yet to achieve this objective fully. eConsent platforms offer an avenue to rectify this by embedding features such as micro-learning videos, interactive elements, and clickable links. Yet, the skill set required to harness these features may not be ubiquitous within site-based clinical trials teams, posing adoption challenges.
Moe Alsumidaie: Why do most respondents, nearly 70%, report managing six or more logins for each study? How does this impact the overall user experience and the efficiency of initiating study-related activities?
Wendy Tate: The sheer volume of logins is indeed surprising. In large centers, the many trials in progress mean each sponsor might introduce a unique technological stack tailored for their trial. While this could be efficient for that specific trial, the coordinators often juggle multiple trials spanning several sponsors, each demanding a unique set of logins. The cumulative effect is a staggering number of logins due to various systems for each study, combined with numerous studies for every coordinator spanning different sponsors. Despite best intentions, sponsors and CROs might still be myopic, missing the holistic perspective of the site.
Moe Alsumidaie: Can you elaborate on the increasing burdens, particularly in setting up and training on trial-sponsored technology? Around 67% of respondents indicated it’s become more burdensome than five years ago. Why is that the case?
Wendy Tate: Indeed, the 67% highlights several issues, particularly the technology burden, which isn’t surprising. What did astonish me was that this concern surpassed even the challenges sites face with budgeting and contracting. Coupled with the previously discussed metric — where sites find engagement tools helpful — it indicates that while technology is beneficial, it’s still burdensome. It’s been over eight years since I worked at a site, and back then, we had fewer tools; much was done on paper, with its inherent inefficiencies. The current training burden arises from the proliferation of tools. The sponsor tech stack has evolved from having IVRs, EDCs, and emails to a myriad of tools, including participant payments, engagement windows, sponsor CTMS, and more. This increase in tools equates to more training. While there’s a push to streamline training during site initiation visits (SIVs), there’s still a perception that everyone needs comprehensive training on every tool. Instead, a more targeted approach, like micro-learning or specific training modules based on roles, might be more efficient. From my perspective, there hasn’t been a significant shift in how training is approached, leading to challenges in implementing new technologies.
We have received feedback from our sites, especially post-pandemic, that remote monitoring has skyrocketed. While this surge has its advantages, monitoring a study, despite being essential, has its challenges. The FDA has advocated risk-based monitoring for over a decade, but a significant portion was still conducted on-site. The global shutdown prompted a pivot to remote monitoring, a trend here to stay. This shift is one of the pandemic-induced efficiencies that has seamlessly integrated into the new normal. However, remote monitoring isn’t without its intricacies. Logins must be set, appropriate access must be granted, and coordinators must respond to queries. Meetings, letters, and other administrative tasks persist. While there’s an uptick in requests for funding for remote monitoring, it likely represents a transition from traditional monitoring fees to this remote paradigm, necessitating additional technological support.
Moe Alsumidaie: Regarding engagement tools, why do at least 50% of sites find site engagement tool options presented in the survey as very or extremely useful? What does this suggest about the evolving needs of the research sites?
Wendy Tate: Clinical trials have indeed become more intricate. We’ve gathered ample information that underscores the increasing complexity of clinical trials. Engagement tools assist in navigating this complexity, particularly when considering trials with multiple segments and varied screening methodologies. For instance, in multifaceted trials with several arms and distinct screening processes, determining the specific trajectory for a basket trial or umbrella trial can be challenging. Tools that can automate particular decision-making requirements, assist with scheduling, and ensure protocol adherence can be immensely beneficial. Sites are keen on maintaining compliance and ensuring participant safety. These tools are perceived as valuable assets that not only ensure compliance but also bolster participant safety. However, the introduction of technology doesn’t automatically translate to simplified processes. A congruent process, in alignment with the workflow, is vital. Tech vendors creating these tools should consider their integration into a clinical research coordinator’s tasks, from scheduling participants, compensating them, and providing them with information (either electronically or in person), to sending visit reminders. If these tools are in sync with the overarching communication strategy and fortify the participant-coordinator relationship, they’re invaluable. They not only serve as reminders for coordinators but also alleviate some administrative burdens, allowing them to prioritize other facets of clinical trials, such as data collection.
Moe Alsumidaie: This is not an easy nut to crack, right? Had it been simple, we would have already found a solution. Given that we’re approaching the end of the year, do you truly believe this problem can be resolved? Perhaps AI could be the answer. With the constant influx of new systems and startups emerging monthly, is it plausible to anticipate a solution to this challenge in the coming year, decade, or ever?
Wendy Tate: I have to remain optimistic and say “yes.” However, realizing a solution will hinge on two pivotal factors. First, there must be a collaborative effort between tech vendors, sponsors, and sites. Solutions must be built with a genuine understanding of the end-user’s needs and challenges, ensuring they’re not just another tool but a real asset. Second, there has to be a willingness to innovate and pivot. The clinical research landscape is evolving rapidly, and our approaches must evolve in tandem. While AI and other advanced technologies offer a glimmer of hope, they will only be as effective as the strategy and understanding behind their implementation. As we’ve seen, the challenges are multi-faceted, encompassing technological, procedural, and communication aspects. It won’t be an overnight change, but with concerted effort and a unified approach, we can make significant strides in the coming years.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.