Sanofi, Bayer, CTTI Explore The Rapid Digitization Of Trials

A recent panel discussion with experts from Sanofi, Bayer, and the Clinical Trials Transformation Initiative CTTI explored the evolution of digital and decentralized clinical trials (DCTs). DCTs, fueled by the COVID-19 pandemic’s restrictions and a shift toward patient-centricity, are expected to grow significantly, with a projected CAGR of 14.8% by 2029. These trials aim to increase patient access and convenience using tools like telehealth, home healthcare, eConsent, and wearable devices, though few trials are fully virtual. Instead, a hybrid model combining on-site and remote elements is most common. This approach has proven effective in fields like multiple sclerosis and dermatology, where decentralized methods reduce patient travel needs and support remote data collection.

However, challenges persist. Regulatory ambiguity around DCT methods, shifting internal mindsets, investigator oversight, and training for clinical sites all present hurdles. To overcome these, proactive communication with regulators, comprehensive DCT toolkits, phased DCT pilots, and detailed oversight plans have proven effective. A methodical approach—assessing challenges, selecting suitable digital tools, measuring impact, and optimizing iteratively—has shown promise in improving trial efficiency and patient engagement. As the industry continues its digital transformation, this structured adoption of DCT elements could accelerate timelines, enhance data quality, and improve overall clinical trial outcomes.