title: Optimization of protocol design: a path to efficient, lower cost clinical trial execution.
abstract: Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials' outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol complexity. This review 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 minimize complexity 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.
authors.affiliation: Department of Surgery, Boston University, 88 East Newton street, Collamore building, Department of Surgery, Boston, MA 02118, USA.
authors.forename: Marina A
authors.initials: MA
authors.lastname: Malikova
keywords: managing complexity; mitigation of fiscal risks; optimization of study protocol design