Digital Technology in Clinical Trials
Session 11 Track B – On Demand: Engage Now, Benefit Later: How Early Supply Management Design Considerations Improve Master Protocol Development
Sylvain Berthelot, MSc
- Director, Solution Consultant
- Calyx, United Kingdom
Master protocols can study beneficial treatments with fewer patients, fewer patient failures, in less time, and greater probability of success than traditional randomized trials. For patients, it provides access to multiple targeted therapies and it reduces the chance of being enrolled in a control arm, with the use of a single control arm across all therapies. The design of master protocols comes with challenges, especially regarding the management of medication supplies and the recruitment of patients to the right sub-protocol, with the right treatment assignment. Experts in IRT (Interactive Response Technology) know which challenges such protocol designs present and can suggest mitigating actions. Engaging with those experts as early as possible in the master protocol design process is a good way for sponsors to understand those challenges and arm themselves with the right mitigating actions to increase the success of their master protocol.
The presentation will be focused on how to shift medication management from single trial to master protocol in IRT. We will share how to plan medication needs across several protocols and what type of solutions are available to trial teams to manage medication for multiple trials at the same time. The audience will learn how to anticipate new drug types that often come with new sub-protocols.
We will also cover the planning of randomization requirements and the flexibility that master protocols require regarding treatment group allocation. The evolutive aspect of basket and umbrella trials increases the risk of mis-randomization and imbalance between treatment groups and sub-protocols. We will discuss how IRT design enables evolution over time, adapting to future sub-protocols, whilst providing the right level of robustness to control those risks.
Learning Objective :
- Understand the challenges to overcome from a clinical supplies point of view when designing a master protocol
- Learn about the different ways that patient randomization can adapt to master protocols
Malcolm Morrissey, PhD
- Associate Director Statistics and Product Support Services
- Calyx, United Kingdom
- Vice President, Scientific E-tech Enabled Services
- Calyx, United States
Preconference Short Courses
Digital Technology in Clinical Trials Resource Kit