A lean-sprint approach to protocol development.

Abstract

e18639 Background: With the ever-increasing complexity of protocols and their required approvals, there is a need to improve the time and reduce the effort required to create a Phase III protocol. The objective of this research was to reduce from months to weeks the time to create a Phase III protocol at a large global pharmaceutical organization, while maintaining or improving the quality and scientific merit of the protocol. Methods: The method required two phases: process redesign and process execution/performance. For the first phase, a continuous improvement methodology (Lean), was utilized. In a multi-team-based approach, the first stage (process-prep) focused on the development of the initial draft protocol. The second stage used the concept of a Sprint, a process to complete all protocol changes and approvals within a rapid time span, while simultaneously guaranteeing protocol quality. A set of policies, procedures, and information technology tools were developed to facilitate both efforts. The Process-prep stage was team-based, where a streamlined Clinical Study Team and a sub-group, the Protocol Working Group, identified all the key tasks, activities and their associated completion dates, and created an 80% complete draft protocol. The Sprint was a one-week, intensive effort by all those responsible for creation of the protocol, and for its final approval. Working virtually and internationally allowed for a continuous 24-hour effort during the Sprint. One key element of success was the use of a visualization tool for the creation, adaptation, and finalization of the protocol’s schedule of assessments (SOA) which both assured that all assessments were required by the protocol and that there was concordance between the protocol and the SOA. Results: Quantitative results were significant: a completed protocol was created with a 50% reduction of time compared to the last protocol written by the molecule group, reduction of avoidable amendments, reducing missed errors and potentially decreasing the number of protocol amendments and the near elimination of process loops and email-chains. Qualitatively, team members were trained on useful process tools and methods, while also increasing their comfort level in active participation in remote meetings. This resulted in faster time to create any amendments that may be required in the future for the protocol. Conclusions: It is possible to employ efficiency and effectiveness methods, such as Lean and Sprint, that have been used successfully in other industries in the pharmaceutical research & development process. While using such concepts requires a great deal of initial planning, the rewards of using them are significant. Likewise, the extensive use of interdisciplinary remote teams will be of increasing importance in a post-COVID environment of clinical research.