A Maturity Model for Clinical Trial Design

Harnessing the Power of Modelling and Simulation

Tom Parke, Head of Clinical Trial Solutions, Tessella Ltd, Bob O’Hara, Managing Partner, ResultWorks LLC

Over the last five to ten years, pockets of change have emerged in advances simulating clinical trials and clinical trial programs, and organizations willing to utilize them. For those who have persevered and evolved with the technologies, the returns have been significant, including reductions in time and cost, and improved decision-making based on scientific data.

This paper proposes a progressive approach to addressing drug development challenges. It is couched in a proposed clinical trial design maturity model which allows for incremental use of effective simulation technologies. Key to the success of the technologies is the organizational commitment to shifting from the current state to increasingly mature methods which affect culture, organization, people, and process. . Over time these technologies are incorporated into individual trials and ultimately into entire clinical trial programs where the returns can be impressive.

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