Veeva Systems has released its Digital Clinical Trials Survey Report, a snapshot of how professionals working in the drug development and clinical research fields are adapting to the rapid adoption of decentralized technologies. According to Veeva, the results indicate that to a significant extend trial pros are rising to the challenge and taking “decisive” action to face challenges associated with the increased adoption of the decentralized format.
Jim Reilly, vice president of Vault R&D with Veeva Systems, spoke with Outsourcing-Pharma about the report, the dynamic changes the field has undergone since COVID-19, and what the results might reveal about the future of the industry.
OSP: Why did Veeva decide to tackle this topic with a comprehensive survey?
JR: At the onset of COVID-19, life sciences companies and regulatory bodies moved quickly to enable remote work and execution across drug development. The industry rapidly adopted decentralized trial models out of necessity which helped keep existing studies on track and start new studies quickly.
It's essential to see decentralization as more than a trending topic. We need to consider how it best fits into a long-term clinical strategy. With the industry evolving so rapidly over the last year, we think it is the right time to explore how technology is driving success, where issues lie, and how clinical leaders are thinking about the future of trials.
OSP: What did you hope to (or expect to) learn from the survey?
JR: We wanted to understand the implications of rapidly adding new applications to an already complex clinical systems landscape and where there are opportunities to make studies faster and more cost-effective.
To advance to digital trials, it's important to understand what the industry's top priorities for improvement are. Veeva is a trusted partner for more than 400 organizations using Veeva Vault Clinical Suite applications, so providing insights into lessons learned from decentralization can help inform their strategies for patient-centric and paperless trials.
OSP: In general, what did the responses reveal about the clinical trial industry—its state, the outlook of professionals, what lies ahead, etc.?
JR: There's been an acceleration of digital transformation in clinical research, starting with the rapid deployment of decentralized trial models to enable remote execution during COVID-19. Today, 87% of companies use decentralized technology, up 59 percentage points from pre-pandemic. Companies added an average of four new applications to their clinical landscape, leading to increased challenges with fragmented systems and processes.
The research also shows that clinical leaders are taking action to expand their study models beyond decentralization. Sponsors and CROs are moving to establish a connected clinical ecosystem that improves collaboration with research sites, drives better patient engagement, and allows seamless data sharing across study stakeholders.
Decentralized trials have driven positive change so far, but more work lies ahead for true, end-to-end digital trials.
OSP: Were there any surprises or otherwise notable results?
JR: Research sites' lack of technology adoption was notable, as 70% of sponsors and CROs report this is their top challenge. The reluctance to adopt new tools is an indication that the addition of decentralized technologies increased operational complexity for research sites. Sites already use multiple systems across trials and sponsors, and the addition of new apps and interfaces with no familiarity or training makes execution harder.
It is also surprising to see that companies didn't report more benefits from decentralized trials. Nearly a quarter say they saw a benefit of shorter trial timelines, and only 18% report improvements with data quality, highlighting the need for better connections across patients, sites, sponsors, and CROs.
OSP: From your perspective, what were the most noteworthy findings or key takeaways?
JR: The level at which sponsors and CROs report challenges with decentralized trials, as 99% say they have significant issues. This makes sense because the more applications used to manage clinical trials, the more challenges companies report. Using different solutions for remote monitoring, eConsent, or ePRO adds complexity because the systems don't usually talk to each other. A fragmented clinical landscape slows down execution and impacts study quality.
Life sciences companies are taking action to establish a digital foundation by better supporting sites with technology, improving collaboration, and addressing system interoperability. This highlights where the industry's priorities are and the key areas sponsors and CROs are investing in to move toward digital trials.
OSP: What do you hope clinical study professionals and other stakeholders across the drug development pipeline might do with this information?
JR: The report sheds light on the importance of improving the patient experience, adopting site-centric technology, and connecting the trial ecosystem. Decentralized trials showed us what is possible in remote execution, but important work remains. Companies will continue to invest in rationalizing systems and eliminating silos and manual processes, advancing to a patient-centric digital trials platform.
OSP: Anything else to add around digital trials?
JR: When you think about what's happening in life sciences, we've had no shortage of transformation. Rapid vaccine development for COVID-19, advancements in how therapies are developed, and improvements in how the industry works together. But there are still questions around where we're going to end up. What will be the next level of clinical trial execution?
At the core, the evolution of drug development has been fueled by a shift to digital ways of working. This research showcases the benefits and challenges of moving to digital and the opportunities for improvement.
At Veeva, we have a vision for digital trials. It brings together sponsors, sites, and patients in a connected way to enable faster and more efficient studies. We're seeing an acceleration toward a connected digital trial model that allows more efficiency and drives better engagement with sites and patients. That is where the industry is going, and we're excited to partner with companies like LEO Pharma to make this a reality.