Enabling Adaptive Clinical Trials through Integrated Development and Manufacturing Solutions
Summary: The adoption of adaptive designs in clinical trials represents a paradigm shift towards a more efficient and flexible approach, overcoming the limitations of traditional fixed designs. Adaptive designs expedite and refine various aspects of the trial design, ultimately safeguarding patients from ineffective treatments. One of the operational challenges limiting the adoption of adaptive designs in clinical development programs is the time it takes to manufacture GMP clinical supplies at trial sites. A viable solution to this challenge is the manufacturing of formulations and dosage forms “on-demand,” which not only enhances dosing flexibility but also considerably reduces development timelines and costs. It optimizes the use of active pharmaceutical ingredients (API) and supports decision-making in dose selection with real-time clinical data. In this webinar, industry experts will discuss how a manufacturing on-demand strategy can enhance your clinical development and improve drug supply utilization. Additionally, the experts will share how to ensure that your adaptive trial is appropriate for regulatory submission.