CRO Breakfast


Thu, December 11, 08:00 – 10:00


Coast9 , 11120 Roselle, San Diego


Use of Clinical Trial Simulations to Optimize Clinical Trial Design:

Often, various design changes are incorporated into a study without a full understanding of how these changes affect key study outcomes. One solution to this dilemma is the use of clinical trial simulations where potential design changes are tested to assess how they impact key study outcomes such as time to completion, cost, and the accuracy of the study primary endpoint.

Use of Data in Clinical Trial Optimization:

With all of the information that exists, leveraging that data in a comprehensive way, with both hindsight and foresight, at the point of key decisions is important to optimize performance. This discussion will illustrate how rounding out the planning process with standardized data from internal performance benchmarks, external industry benchmarks, real world evidence, predictive analytics and CRO/field based insight, companies are able to build, manage and execute their portfolio of trials based on data-driven, pressure-tested, collaborative plans to achieve better outcomes.

Optimization through Adaptive Trial Design:

Adaptive designs utilize accumulating data/results from an ongoing trial to modify the trial's course, and was originally applied only to early phase clinical trials to assist with identifying doses and/or compounds worthy of further development. However, more recently this approach is being applied to late stage clinical trials, including pivotal trials, which should improve the efficiency and success rates of clinical development programs.