PAREXEL - Dr Sy Pretorius on the Impact of Protocol Optimization in Clinical Studies
Clients find PAREXEL protocol optimization very helpful. In fact, protocol optimization can have a tremendous impact for a company – especially in large and costly trials. A recent study done by Tufts found that one fifth of the Phase II and a third of Phase III protocol procedures, on average, collect non-core data that are not associated with a primary or key secondary endpoint or regulatory compliance or standard baseline assessments. Eliminating these non-core procedures has a tremendous impact on both the cost associated with a study as well as the time that it takes to complete the study. Changing the design or one of the other building blocks often result in similar cost and time savings. Likewise, protocol amendments typically have a significant impact on study cost and timelines and data has shown that many of these amendments can be avoided by employing processes such as protocol optimization at PAREXEL. Our goal is to simplify the journey between science and new treatments and to help our clients bring new drugs to market for the patients who need them. Protocol optimization at PAREXEL is one way we simplify this journey.