The protocol is singularly the most important document in the clinical development process. It is the blueprint that helps align investigators, study teams, institutional review boards, regulatory experts, and other stakeholders — and drives downstream activities. That’s why experts on protocol design and clinical operations say problems that arise later in clinical trials could have been avoided by laying a stronger foundation from the start.This playbook explores the biggest challenges in study plans and shares solutions to improve them and to streamline the entire clinical research process. When designed for the future, protocols can help foster more efficient trials. Highlights include:How complexity, amendments, and eligibility criteria present the top challenges causing protocol breakdown. Five steps to improving protocol design that leverage simplicity, stakeholder engagement, and technology. When and how to experiment with AI for protocol development.
