Adaptive design trials offer the potential to increase the ability of pharmaceutical companies to successfully bring more effective treatments to the market. Companies that adopt a comprehensive adaptive design strategy across their product pipeline will make better development decisions and ultimately bring effective products to the market more quickly.
A major component of convergent development combination treatment approaches ― which unite two or more different types of regulated drugs or medical devices to enhance patient outcomes ― and their supporting trials, provides a chance for each industry to leverage a mutually beneficial partnership to help ensure their respective products stay on track or are approved for market.
The increasing pace of innovation and blurring boundaries between pharma and device products have led to new drug-device combination products and the need for updated regulatory guidances. The EMA has published a Q&A document detailing information for products that need both the drug and the device components to function.
Over the past several years, regulators, including the FDA, EMA, and PMDA, have provided guidance on the use of adaptive design for clinical development. Read how the FDA and EMA thinking on adaptive designs has progressed significantly and support for the approach has strengthened.
Identifying appropriate dose ranges for pivotal trials remains a major drug development challenge, particularly for new molecular entities. Adaptive MCP-Mod designs help to reduce costs in futile developments programs, while preserving predictive insight in successful development programs, actively supporting early development preparations leading to shortened timelines.