Adaptive Trial Design: Challenges for the Project Manager
Alexander Gissler - Director - ProjectPharm Ltd.  

During the past 10–15 years, due to regulatory requirements, budgetary constraints as well as the need to reduce time to market, clinical studies have become more and more complex. This resulted in the challenge, for clinical research departments and CROs, to transform the role of the clinical study manager to one of a real project manager, who could be held responsible for the overall performance of a clinical study in terms of not only scope, time and budget, but also risk, quality, as well as customer satisfaction.

Adaptive trial design further increases this challenge, as due to this concept, which evolves with the course of the study itself, the planning process has to be ongoing, and needs thorough planning itself: Planning for unknowns and uncertainties can best be dealt with by generating a plan for the plan, i.e. determining a priori "Who will be involved in planning What, and When such planning will occur".

The strongest focus for the project management team will lie on scope, risk, and quality management, with the biggest key factor to success being an excellent stakeholder and communication management.