The biggest challenge, in the implementation of M&S projects, institutions face today is team structuring and communication. Successful execution of an M&S project undoubtedly requires teamwork and cooperation among scientists from various disciplines (e.g., clinical, pharmacometrics, statistics) and institutions (such as FDA and the industry). As aptly noted by Sheiner , a clear definition of the roles of the "domain experts" (such as clinicians/regulators) and "subject matter experts" (such as pharmacometricians/statisticians) is the key to success and efficient management of an M&S project. The domain experts would provide the answers for the questions: (1) What do we want to know? (2) What are we willing to assume, and (3) how certain do we need to be? Once the answers for these questions are provided the subject matter experts will provide the suitable experimental designs and analyses plans. It would take few iterations to arrive at the final answers (which are in fact questions) and a prospective design to achieve them. The M&S can be used as a very effective tool during these "iterations." Now, this exercise is particularly effective when the discussions are between the regulatory agency and a drug sponsor. The regulators will be in a position to comprehend "quantitatively," the rationale for the selection of a particular clinical trial design, in a timely fashion. Further, the pharmacometricians and statisticians, who are the designated "subject matter experts," need to have a more active exchange of knowledge across the two disciplines.
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