Implementing Adaptive Designs: Logistical and Operational Considerations
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ADAPT I VE DES I GN 437
Judith A. Quinlan GlaxoSmithKline
Michael Krams Wyeth
Key Words
Adaptive Design; Modeling; Drug supply; Electronic data capture
(orrespondence Address
Michael Krams, Assistant Vice President. Adaptive Trials. Clinical Development. 500 Arcola Road. A-s113. Collegeville, PA 19426.
Implementing Adaptive Designs: Logistical and Operational Considerations
INTRODUCTION The successful conduct of any clinical trial requires cross-departmental coordination. This is true regardless of the trial design. However, it could be argued that the successful implementation of adaptive designs relies even more on integrating input from a number of different line functions, including biometrics, clinical research, data management, drug supply, and clinical operations. This provides both a challenge and a unique opportunity to improve the waywe work. The logistical infrastructure supporting the conduct of a trial obviously reflects the needs of the underlying trial design. The long and successful tradition of "nonflexible," double-blind, randomized, parallel group designs has led to the development of systems and processes as now established across the industry. Supporting adaptive designs with the currently available infrastructure is not impossible but may be viewed as challenging. Adaptive designs would benefit from building (1) flexibility and (2) the capability for high-speed data acquisition/analysis/reporting into the infrastructure supporting the trial. The full benefits of integrated flexibility across the broader infrastructures of trial support will become visible once they are deployed on a portfolio level, across several trials, and across a number of compounds. Importantly,
The objective of this article is to support a logistical and operational feasibility analysis: given the research question and the environment in which we work, is it appropriate to consider an adaptive design, andare we sufficiently well prepared to deploy successfully?
some of the proposed changes willyield benefits irrespective of whether the design contains elements of adaptation. But, systems and processes with enhanced flexibility and speed will clearly also act as an enabler for the deployment of adaptive designs. While the implementation of integrated platform technology is desirable and beneficial to the conduct of adaptive designs, it is not a necessary requirement. We want to stress this to avoid the misperception that implementing adaptive designs is only possible in a high-tech environment. Nevertheless, it should be acknowledged that advances in technology may potentially hold the key to promoting transformational change to the clinical development paradigm. It is from within this environment that we may see adaptive designs being levered from being a minor player, as is the case today, to a major player within early- and late-phase clinical development programs. Current advances in technology, in which electronic data capture is increasingly becoming commonplace, are perhaps just the beginning. It is not
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