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Starting the Conversation Early: Incorporating Business Considerations in Optimal Selection of Trial Design


When developing clinical strategy, applying familiar business principles to the specific requirements of clinical research requires bridging two paradigms and adjusting the insights from each. Cytel’s new series of position papers on Empowered Selection, aims to empower CMOs and those responsible for R&D to select clinical trial designs informed by economic choice theory, most notably rational choice theory and decision theory.

The first of these position papers examines the functional uses of the concept of pareto optimality, as applied to the clinical development process. Sponsors with firm resource constraints still deserve to know that their clinical trial design optimizes for accelerated timelines, power and cost effectiveness. The idea of pareto optimality creates a decision framework by which to do this.

Pareto optimality typically refers to the optimal allocation of resources with respect to a specific set of preference criteria. For clinical strategy, those preferences can include speed to market, clinical operations costs, the power of a study, and so forth. Pareto optimal resource allocations are those which cannot create improvements along one of these preference criteria without diminishing at least one other.

Research spearheaded by Cytel co-founder Dr. Nitin Patel and Chief Scientific Officer Dr. Yannis Jemiai, demonstrates that this simple concept can be used by sponsors to focus clinical strategy discussions and begin the conversation about resource allocation and clinical trial optimization much earlier in the drug development process. Given the right technology, it can help align trial selection processes with conversations about eNPV, offering sponsors a roadmap, so to speak, of the entire journey beginning with Step 1.

Many sponsors assume that conversations about profit and revenue begin with comparative effectiveness and market access strategy, but this position paper highlights how certain elements of strategy can be built into a product’s success much earlier.

Download the paper to learn more:

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About Yannis Jemiai

Yannis_JemiaiYannis Jemiai has a pivotal role within Cytel as Chief Scientific Officer he has oversight for the corporate-level Scientific Agenda which includes establishing research portfolios in Bayesian, small sample, and other flexible designs; as well as complex innovative designs including adaptive trials, master protocols and MAMS. Yannis also has an extensive portfolio of research in adaptive trial design, financial and pharmaceutical strategy, decision theory, and regulatory affairs.

His own research has been published in numerous statistical journals. Dr. Jemiai earned his Ph.D. from Harvard University, an M.P.H. from Columbia University, and a B.A. in Molecular and Cellular Biology also from Harvard.


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