SOURCE: Xtalks

Xtalks Webinars

September 27, 2017 07:30 ET

Adaptive Trial Design and Incorporation of Biomarkers to Maximize Achievable Objectives in Early Phase Clinical Studies, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - September 27, 2017) - During a live broadcast on Friday, October 13, 2017 at 2pm EDT, industry experts from WCCT Global David R. Mcllwain, PhD, Scientific and Medical Affairs Subject Matter Expert and Kalyan Ghosh, Vice President of Biostatistics will discuss adaptive designs and focus on strategies for achieving additional objectives through the inclusion of biomarker evaluation in Phase 1/2 clinical trial design.

Early phase clinical trials can be designed in such a way that multiple objectives are achieved within a single protocol, improving the overall efficiency of the drug development process and reducing the time necessary to reach late phase trials. Such early phase clinical trial designs combine food effect, PK/PD, drug-drug interaction, bioequivalence and bioavailability, age and gender studies, and ethnic populations. However, the desire to further expedite the development process has put pressure on drug developers to find ways in which to achieve even more objectives early on in the development cycle, particularly during early phase studies. A host of strategies for increasing measurable clinical objectives were outlined in FDA's Critical Path Initiatives (CPI, 2006); two of the most important are the employment of adaptive clinical trial designs and the use of biomarkers.

Adoption of biomarkers has been one of the most important initiatives in CPI. A validated pipeline of high quality sample preparation, and the use of cutting edge multiparameter analysis tools for simultaneous measurement of large numbers of potential biomarkers, maximizes the potential to identify populations who will experience maximum therapeutic efficacy in later study phases, and opens doors to providing personalized medicine. To demonstrate the use of biomarkers in early clinical trials, WCCT will highlight the inclusion of immunological biomarkers for the development of new vaccine and oncological treatments.

While the inclusion of multiple objectives in one single trial offers clear benefits for decreasing development time, potential concerns around increasing chances of observing spurious signals frequently exist. WCCT will cover the relevant statistical issues that arise in this setting, and discuss 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 studies, WCCT will provide examples from recent development programs in which these strategies were implemented.

To learn more about this complimentary event visit: Adaptive Trial Design and Incorporation of Biomarkers to Maximize Achievable Objectives in Early Phase Clinical Studies


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