Applying The MIQE guidelines to clinical and pre-clinical trials

Maxime Dooms2, Abalo Chango2, Essam Azhar1, Steve Harakeh1, Elie Barbour3, Flore Depint2, Afif Michel Abdel Nour1
1KAU/KFRMC/ Special Infectious Agent unit Biosafety Level 3, Saudi Arabia; 2Institut Polytechnique LaSalle Beauvais, Beauvais, France;3American University of Beirut, Beirut, Lebanon

The ‘‘Minimum Information for the Publication of qPCR Experiments’’ guidelines are targeted at gene expression experiments and have to our knowledge not been applied to qPCR assays carried out in the context of clinical trials. This report details the use of the MIQE qPCR app for iPhone (App Store, Apple) to assess the MIQE compliance of one clinical and five pre-clinical trials. This resulted in the need to include 14 modifications that make the guidelines more relevant for the assessment of this special type of application. We also discuss the need for flexibility, since while some parameters increase experimental quality, they also require more reagents and more time, which is not always feasible in a clinical setting. The second part of my talk will be an update on the MIQE-qPCR app through numbers since 2011. I will finish by a quick review on the implementation of the MIQE guideline in the Middle East challenges and opportunities.

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