Optimisation of Protocol Design: A Path To Efficient, Lower Cost Clinical Trial Execution

About this session

Session: NEW TRENDS IN PROTOCOL DESIGN: REDUCING SITE AND PATIENT BURDEN

This session will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and the right data are collected to demonstrate that a drug is safe and efficacious, while managing study costs and study complexity based on proposed comprehensive scoring model. Key factors to consider when developing protocols and techniques to minimise complexity, as well as patient burden index, will be discussed. A methodology to identify processes at planning phase, approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials will be addressed.

Speaker

• MM

  Marina A Malikova

  Asst Prof & Exec Dir · Boston Medical Ctr

  Speaker