Redefining Complexity through the Lens of the End-user
Traditionally, complexity in clinical trials is translated into increased operational challenges due to the presence of several IMPs, populations, trial sites, multiple sponsors and/or manufacturers and contract research organizations (CROs).
Common examples of complex clinical trial designs are basket, umbrella, and platform trials. These designs are primarily used in Oncology, but they may be applied in other therapeutic areas if there is a good rationale and the design is appropriately justified.
Basket trials investigate the safety/efficacy of an IMP or combination of IMPs across a variety of populations, while umbrella trials investigate the safety/efficacy of several IMPs in a single population. Whereas platform trials may test several IMPs in one or multiple populations in a highly dynamic design.
RTSM/IRT technologies that support these trials must be flexible enough to enable intricate designs while also protecting the blind, adhering to GDPR requirements and restrictions, managing frequent protocol amendments and more recently, aligning and setting up hybrid Decentralized Trials. As such, RTSM/IRT solutions can enable complex protocol designs by mitigating potential challenges inherent to the choice of complex design elements, features, methods in the protocol, etc.
This article examines clinical trial complexity through the lens of study investigators, site staff, CRAs, sponsor study and supply managers, and how the RTSM/ IRT provides the ability to be as creative as needed within the design to meet trial endpoints. It does so by assessing the following 6 operational challenges.
Operational Challenges Addressed in the RTSM/IRT
Complex clinical trials require intensive peer-level interaction and agreement between clinicians (community of investigators, clinical researchers), methodology experts (statisticians, biometricians, modeling and simulation experts) and project teams (organization, performance of trial) about the choices in scope (subjects and conditions to be included), main design features (medicinal products, arms, endpoints) and adaptations.
RTSM/IRT solutions can enable complex protocol designs by mitigating potential challenges inherent to the choice of complex design elements.