Oncology division officials summarize the agreements and discussions reached during formal meetings so there are no misunderstandings later. Sponsors want the practice used more widely by the FDA.

From synthetic data to real-world data, from patient engagement to patient stratification, from combination trials to master protocols and from fully decentralized through hybrid to onsite trials, the world of clinical development is undergoing major changes. Fifty executives share their predictions around clinical trial trends for the year ahead.

The agency’s existing technical standards are better-suited to clinical trial data, and mapping RWD to these formats will result in the loss of granularity and introduce new opportunities for human error, pharmaceutical industry representatives and data companies say in comments on a draft guidance.

McKinsey senior partner Joseph Hughes outlines the shape of things to come as new technologies transform life sciences manufacturing, while new modalities around cell-, gene- and RNA-based therapeutics could have “profound implications” on global operations networks.