Abstract: With increasing numbers of clinical trials involving biological medicinal products, they have become a topic of much discussion regarding quality, including the upcoming quality guideline, as recently discussed in this journal. But what of the clinical aspects to these trials? This article provides some insight into the review process of biological clinical trial applications (CTAs) by the MHRA Clinical Trials Unit (CTU) that may then assist in future applications. It should be remembered that, as with all clinical trials, academic and non commercial trials are subject to the same scrutiny as commercially-sponsored biological trials regardless of the use biological products.
Author: Kirsty Wydenbach, Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.
Cited on: Regulatory Rapporteur – Vol 9, No 5, May 2012, TOPRA.
Further Information: Clinical trial applications for biologicals: a UK regulatory clinical perspective
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