DIA/FDA Statistics 2016 Forum

Session 9 will focus on two ICH guidelines:

E14 – Q&A Document on QT prolongation study requirement; Update to allow use of concentration-response modeling
The hypothesis between a prolonged QT interval and Torsade de Pointes (TdP) cardiac arrhythmias is well-accepted by the medical development community and has been the subject of significant effort with regard to the safety of prescription drugs by the FDA. This effort has included the development by the International Conference on Harmonization (ICH) of the E14 Guidance (Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs.). As the understanding of this phenomenon has progressed, the medical development community has been looking for improvements on this methodology. One popular alternative approach is the Concentration Response Relationship (CRR) method. Experiences by all parties with the implementation of the E14 Guideline have resulted in the need for some clarification. The Questions and Answers developed by the E14 Implementation Working Group (IWG) are intended to facilitate the implementation of the E14 Guideline by clarifying key issues.

The session will start with presentations by key players in these ICH guidance’s, followed by a panel discussion to further elucidate major issues. This panel is expected to feature thought leaders not only from US but globally. Adequate time for floor discussion will allow participants to interact with the thought leaders.

E17 – Multi-Regional Clinical Trials (MRCTs)
With the increasing globalization of drug development, it has become important that data from MRCTs can be accepted by regulatory authorities across regions and countries as the primary source of evidence to support drug registration. The purpose of this guideline on MRCTs is to minimize the need to conduct single country, regional or bridging studies. This guideline describes general principles for the planning and design of MRCTs with the aim of increasing the acceptability of the use of MRCTs in global regulatory submissions. It also addresses some strategic program issues as well as those that are specific to the planning and design of confirmatory MRCTs and should be used together with other ICH guidelines.