Clinical Trial Trends: 18 Months of Faster Tech Adoption, Real World Data, Increased Collaboration
By Allison Proffitt
September 22, 2021 | Nimita Limaye, Research VP at IDC, gave a broad overview of IDC’s survey findings over the past 18 months at this week’s Bio-IT World Conference and Expo held in Boston and online. She highlighted trends in the life sciences and clinical trials industries that included increased collaboration, speedier adoption of technologies, reliance on real world data, and more.
After the unprecedented disruption of the COVID-19 pandemic, companies in the life sciences industry returned with a focus on digital resiliency—seeking to recover and grow in the new times.
Pharma has viewed the past two years as a proof-of-concept study, Limaye said, for various new technologies that the industry would otherwise be slow to adopt. While in the past, policy has generally dictated practice, Limaye reported that today in the clinical trials industry practice informs policy.
Decentralized clinical trials, she said, are no longer considered a “fashion statement”. Instead, Limaye reported that by the end of 2020 more than 90% of clinical trials were decentralized. There was a meaningful shift, she said from “site-centric” to “patient-centric” trials and from collecting discrete data points to gathering continuous data measures and remote patient monitoring.
COVID-19 is not just a respiratory illness—instead it has been a “pandemic of stress”, Limaye said. This stress has prompted an increase in focus on mental health, and FDA relaxed regulations around digital solutions for behavioral health. Limaye and IDC are expecting “double digit growth in the next five years for prescription digital therapeutics,” she said.
The technology has grown as well, with the “Internet of Medical Things” exploding—blurring, Limaye said, the line between healthcare and life sciences.
IoMT includes sensors, wearables, “invisibles”—tattoos, biostamps, and other non-intrusive wearables—and other human-centric designs for remote monitoring. Currently most of the products being developed are digital companions to existing therapeutics, Limaye said. And IDC survey found that nearly two-thirds of the industry is piloting or developing smart watches for clinical trials and predicts that three-fourths of trials will include a wearable by 2025. The rise in digital biomarkers could preempt health issues, making “care anywhere” a reality.
These types of data are part of a larger shift toward real-world evidence, though Limaye highlighted that RWE is being focused earlier in the pipeline: less for commercial launches and more to inform R&D. “The industry is looking at leveraging data to optimize trial design, improve patient recruitment criteria, as well as support regulatory submissions or label expansion,” she said. “The value that real-world data is really bringing to the table is around clinical heterogeneity.”
Of course that increasing rush of data is comes with its own challenges. “Data chaos” is growing exponentially, Limaye said, driven in part by the disaggregation of care. “We actually saw a drop by a billion in the number of in-patient visits that were happening over the past year, but you also saw simultaneously a jump in the number of televisits, going up from 45% to around 85%,” she said.
Infrastructure has grown to accommodate the data volumes. IDC surveys find a corresponding jump in GxP compliant unified cloud platforms. Limaye reported that about half of the life sciences industry has moved to a public cloud, but also reported a more recent shift back to private cloud.
Flexible compute is also supporting the push toward AI and machine learning-driven predictive analytics. IDC surveys predict a CAGR for machine learning in clinical trials of 23.4%, and a 65% increase in AI spending over the next 12 months for life sciences companies. According to survey data, the increased AI investment is driven by improving employee productivity, new product development, and improved risk management. Limaye also reported that 2/3 of the industry will have deployed AI algorithms for RWE by the end of this year.
But one of the biggest trends that Limaye reported had nothing to do with new technologies or product lines. If nothing else, COVID has emphasized the need for collaboration within the industry. “COVID really brought this message home that you really need to collaborate if you want to accelerate innovation,” she said. Digital ecosystems are the future, she argued, reporting that 70% of the life sciences companies in the EU plan to join an industry digital ecosystem.