High-profile industry experts and regulatory officials discussed, at a recent summit, a range of issues around trends in clinical trials including the role of digital technologies, metadata-driven automation and also real world data and predictive evidence in insight generation.
Bayer’s Koenen: Decentralized Trials For Pivotal Studies Not 'Black Or White Scenario'
A cross-section of biopharma experts including senior executives of Bayer, Boehringer Ingelheim and Accenture and US FDA Director at the India Office deliberate digitization and evolving trends in clinical research, including the potential of decentralized trials and metadata-driven automation.

More from Clinical Trials
RemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.
The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.
With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.
More from R&D
The Danish firm is spending nearly $580m to repurchase up to 2.2 million shares
The Texas-based firm is giving up on the investigational Alzheimer’s therapy after a second Phase III failure left it with nowhere to go in the disease.
A decision from the FDA is due by 28 September.