Clinical Researcher—April 2022 (Volume 36, Issue 2)

OVER THE TRANSOM

Gary W. Cramer, Managing Editor for ACRP (gcramer@acrpnet.org)

It’s no secret that some of we few, we happy few, on the ACRP staff have been spending quality time lately collaborating with ACRP Fellows and other experts from beyond the Association to hone our understanding of what decentralized clinical trials (DCTs) are, to appreciate how they function ideally, and to share what stakeholders in the clinical research enterprise need to know about them as they evolve beyond their utility in pandemic conditions into what looks to be an ongoing and potentially game-changing presence in the clinical trials arena.

For this installment of our humble column on news from the wonderful world of press release services and public relations offices, we offer glimpses of how various organizations (no endorsements implied) are tapping into the gearworks of DCTs to see for themselves if the payoff lives up to the hype.

U.S. Leading the Way in Virtual Trial Adoption

The term DCT (they are also known as remote/virtual trials) refers to digitally empowered clinical trial processes. The market growth is driven by growing adoption of virtual trials following the outbreak of the COVID-19 pandemic. Medi-Tech Insights in March reported that the global virtual clinical trials market is estimated at close to $8 billion as of 2020, and is growing above a 10% compound annual growth rate. Key players in the virtual clinical trials market are ICON, Parexel, IQVIA, Covance, Thermo Fisher, LEO Innovation Lab, Huma, Medidata, Oracle, CRF Health, Medable, Signant Health, and Clinical Ink.

The number of venture capital funding deals involving DCTs has increased post-COVID-19, the consulting service adds. There were six deals in 2018 which increased to 18 in 2020. Most venture capital funding occurred in Q3 2020 (10 deals). Notably, Medable—one of the fastest growing DCT platform providers—raised $524 million from various rounds since 2020. One of the biggest rounds occurred in October 2021, when the company received $304 million in Series D funding. Growing venture capital funding will enable companies to make technological advancements and increase their customer and geographic reach, Medi-Tech Insights predicts.

Meanwhile, comprehensive regional assessment of the virtual clinical trials market suggests that the U.S. is currently the largest such market. On the other hand, European life science/medical device companies have not moved as rapidly to adopt virtual trials as the U.S. However, there have been developments taking place in the European Union that are expected to propel the adoption steadily, the consulting firm notes.

Bringing Artificial Intelligence to Bear

THREAD, a technology and consulting service provider from North Carolina enabling electronic clinical outcome assessments and DCTs, announced in late March that it is collaborating with Amazon Web Services, Inc. (AWS) to launch enhancements to the THREAD platform powered by enterprise-scale automation and built-in artificial intelligence (AI)-driven technologies. The company says that these next-generation DCT technology features will serve as the backbone for modern clinical research by enabling faster, more efficient clinical trials while improving access for research participants with higher quality data capture across the life cycle of a study.

THREAD is working with AWS Professional Services experts to design an advanced machine learning architecture and AI models to automate processes for customers. THREAD’s hope is that its new cloud-enabled platform features will accelerate clinical research by reducing inefficiencies in real-time data capture, auto-populating data workflows that are completed manually today, and more.

Accelerating Adoption, Increasing Access

Also in late March, ActiGraph, a Florida-based provider of wearable, technology-enabled scientific solutions for clinical trials and academic research, announced it has joined the Decentralized Trials & Research Alliance (DTRA). By enabling collaboration between stakeholders, the DTRA accelerates the adoption of patient-focused DCTs and research within life sciences and healthcare through education and research.

“Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives—and by taking part in the DTRA, ActiGraph is joining the many entities that are contributing to this mission,” said Craig Lipset, DTRA co-chair. “We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders, we can remove remaining barriers to adoption and impact patients today.”

Meeting the Needs of Growth and Expansion

Last, but not least, CCT Research in Arizona has announced the addition of a new DCT-focused team dedicated to supporting a positive subject experience and delivering exceptional quality data as the company continues to grow and expand. The company notes that this team, made up of experienced and remote clinical research coordinators (CRCs), “will be pivotal…to expand [our] reach and management of clinical trials by providing expert support to all subjects and sites within the network.” CCT adds that the team “will operate in a hybrid environment that will blend traditional clinical research and current technology to provide a contemporary definition to the CRC role.”

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