Active oncology R&D compounds have quadrupled since 1996 and doubled since 2008. With accelerated approvals and breakthrough designations, where speed is of essence, fierce competition has become inevitable. But speed doesn’t necessarily mean faster approvals because oncology clinical trials are also becoming increasingly complex. Fortunately, revised ICH E6 guidance on risk-based monitoring (RBM) can fundamentally transform these approaches to help keep up with fast-paced oncology trials, contrary to popular belief that RBM can slow you down.
How is ICH GCP E6 R2 making it easier for patients to receive the right treatment at the right time? What can you do to stay ahead of the competition?
Join thought leaders from EMD Serono, Accenture and Medidata to learn about:
- Essential elements of RBM, straight from the drawing board of ICH E6 R2 working group
- The unspoken patient impact of RBM
- RBM’s role in addressing complexities in oncology clinical trials with a roadmap to get ahead