Hoping to accomplish more with your upcoming Early Phase Clinical Trials?

The desire to further expedite the development process has put a pressure on drug developers to find ways in which to achieve even more objectives during early phase clinical trials. In the FDA’s Critical Path Initiatives, two of the most important strategies for increasing measurable clinical objectives were the employment of adaptive clinical trial designs and the use of biomarkers.

On Friday, October 13th, WCCT Global hosted a webinar entitled “Adaptive Trial Design and Incorporation of Biomarkers to Maximize Achievable Objectives in Early Phase Clinical Studies.”

View the live recording: 

Key Takeaways

  • An overview of adaptive clinical trial designs and strategies for incorporation into early phase clinical studies
  • A discussion on the utility of biomarker evaluation and its influence on drug development in early stages
  • Examples of previous WCCT programs which implemented adaptive trial design and incorporated biomarker evaluation to achieve objectives
  • Consideration of the statistical issues that arise in this setting and possible responses to ensure that valid statistical inferences can be drawn for each set of objectives

In this webinar, two of WCCT’s industry experts discussed adaptive clinical trial designs and focused on strategies for achieving additional objectives through the inclusion of biomarker evaluation in early phase clinical trials. The adoption of biomarkers has been one of the most important initiatives in the FDA’s Critical Path Initiatives. David McIlwain, WCCT’s Scientific and Medical Affairs expert, demonstrated the effectiveness of biomarker evaluation in early phase clinical trials, focusing specifically on the inclusion of immunological biomarkers for the development of new vaccines.

While the inclusion of multiple objectives in a single trial offers clear benefits for decreasing development time, potential concerns around increasing chances of observing spurious signals frequently exist. WCCT’s Vice President of Biostatistics, Kalyan Ghosh, responded to the relevant statistical issues that arise in this setting, and discussed strategies to ensure that valid statistical inferences can be drawn for each of the objectives.

In addition to discussing strategies for developing protocols which will achieve maximum objectives in early phase clinical trials, WCCT provided examples from recent programs in which these strategies were implemented.

DOWNLOAD THE PRESENTATION! 

This webinar will focus on strategies for achieving additional objectives in early phase studies through the incorporation of biomarker evaluation in clinical trial design.