Rho site logo

Protocol Design and Development: What You Need to Know to Ensure a Successful Study

chess.jpgSolid protocol design is critical to clinical development. No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing. This presentation walks through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.  Topics include:

  • Writing specific objectives relevant to your stage of development
  • Addressing dosing rationale and study design
  • Reporting adverse events, stopping rules, and suspension guidelines