HIV Working GroupFriday, October 7, 1 pm EST via ZooomDr. LJ WeiProfessor of BiostatisticsLost in Translation in clinical studiesOver the years, the process of designing, monitoring, and analyzing clinical studies for evaluating new treatments has gradually fallen into a fixed pattern. Clinical trialists have sometimes been slow to utilize new methodologies–perhaps to avoid potential delays in the review process for drug approval or manuscript submission. The underlying attitude toward innovation in drug development is in sharp contrast to that in other technologically driven fields. Scientific investigation is an evolving process. What we have learned from previous studies about methodological shortcomings should help us better plan and analyze future trials. Unfortunately, use of inefficient or inappropriate procedures persists even when better alternatives are available. In this talk, we will explore various methodological issues and potential solutions to them. A goal of the clinical study is to obtain robust, clinically interpretable treatment effect estimates with respect to risk-benefit perspectives at the patient’s level via efficient and reliable quantitative procedures. We will discuss how to achieve this goal via various real trial examples.
