The 2024 SCOPE Summit catalyzed thought-provoking dialogue on the transformative currents sweeping through the clinical trials landscape. Hassan Kadhim, Business Engagement Lead, Clinical Operations and Clinical Development Technology at Vertex Pharmaceuticals, was at the helm of this discussion and adeptly steered a panel of distinguished experts. Joining him were Craig Lipset, Founder and Advisor at Clinical Innovation Partners and Co-Chair at Decentralized Trials & Research Alliance (DTRA), Aman Thukral, Director of Clinical Systems & Digital Operations at AbbVie Inc., and Angela Radcliffe, a seasoned expert in R&D Digital Performance Improvement & Innovation, formerly of Bristol Myers Squibb. Together, they dissected the complexities and opportunities that have surfaced in the wake of significant industry shifts.
The Correction Phase: A New Reality
The conversation acknowledged a “correction” phase within the industry, as the initial burst of innovation faced economic realities. Craig Lipset pointed out the macroeconomic factors challenging the sector, including inflation and changing reimbursement landscapes, alongside a staffing crisis at research sites exacerbated by private equity interest. “We have a crazy dynamic with research sites right now in terms of staffing crises…fighting off 15 to 18 X multiples from private equity firms all trying to buy them up while they’re struggling to find staff just to deliver on the studies that they have,” said Lipset. This shift signaled a need for a strategic reevaluation of innovation priorities, away from unrestricted innovation towards a more sustainable, value-driven approach.
Decentralized Trials: Still Relevant but Evolving
Despite the challenges, the consensus among panelists was that decentralized clinical trials remain a crucial part of clinical research’s future. “So is it hard right now? Does it feel like DCT is in a lull? Absolutely. But will we pull through?…are we going to stop listening to patients? About what their needs are? If the answer is no… then decentralized methods in our trials will remain an important part of our portfolios,” added Lipset. However, the implementation and
“So is it hard right now? Does it feel like DCT is in a lull? Absolutely. But will we pull through?…are we going to stop listening to patients? About what their needs are? If the answer is no… then decentralized methods in our trials will remain an important part of our portfolios”
Craig Lipset, Co-Chair, DTRA and Founder and Advisor at Clinical Innovation Partners
enthusiasm for DCTs have evolved, becoming more nuanced and integrated into broader clinical trial operations rather than being seen as a standalone solution. The panelists argued for a continued focus on patient-centric approaches, suggesting that while the hype around DCTs might have diminished, their importance in enhancing patient access and trial efficiency has not.
AI and Automation: The New Frontier
The SCOPE Summit discussion also explored the role of artificial intelligence (AI) and automation in clinical trials. Unlike the transient excitement over blockchain and RPA in previous years, AI, particularly generative AI, was recognized for its potential to impact clinical research significantly. This optimism is grounded in AI’s ability to streamline data-heavy processes, enhance document management, and improve operational efficiencies. “Clinical research is a very data and document-heavy process. And today AI, specifically the generative LLMs (large language models), they are very fine-tuned, and they have produced exemplary results in the document and the content space which we never witnessed in RPA (robotic process automation) or blockchain,” said Aman Thukral. However, the SCOPE Summit panelists cautioned against viewing AI as a panacea, emphasizing the importance of strategic integration and addressing organizational challenges to leverage AI’s capabilities fully.
Looking Ahead: The Role of Innovation and Collaboration
The panel highlighted the importance of embedding innovation into the fabric of clinical research operations rather than treating it as an ancillary function. There was a call for greater collaboration within organizations and across the industry to de-risk and accelerate the adoption of innovative methods and technologies to buck the status quo culture that has confined the clinical trials industry for decades. Consortia like TransCelerate, DTRA, and SCRS were highlighted as vital for creating shared spaces for innovation, ensuring that advancements in clinical trial methodologies benefit the entire ecosystem. “At DTRA this year, we’re putting more energy into shared spaces to de-risk some of the methods that are clogging the funnel. Because for so many organizations, even if new talent comes in, the same staff are in the funnel, we’re all chasing the same objects… So how can we… derisk some of those new approaches and methods to be able to help bring some lubrication to a funnel that has too much friction?” said Lipset.
Conclusion
As projected by the discussions at the 2024 SCOPE Summit, the future of clinical trials is one of dynamic integration, where decentralized clinical trials will continue to evolve and embed within the larger framework of clinical research operations. With a clear consensus on the value of patient-centric approaches, the industry is poised to leverage AI and automation judiciously, ensuring these technologies augment rather than overshadow the human aspect of trials. The collaborative spirit echoed by the SCOPE Summit panel, with a nod to consortia and initiatives, suggests a shift towards a more interconnected and mutually supportive clinical research environment. As we look ahead, it’s evident that the industry is charting a course toward more resilient, inclusive, and technologically harmonized clinical trials, aiming to deliver transformative healthcare solutions with patients at the heart of every innovation. However, challenges, such as cultural shifts towards innovation in the clinical trial industry and fitting infusing novel technology into organizations, remain.
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.