Aardvark released exploratory data from its stopped Phase 3 HERO trial in Prader-Willi syndrome after FDA lifted the hold, and plans a redesigned Phase 3.
|Articles|June 1, 2015
IACOR Comment on EU Clinical Trial Directive
IAOCR, a provider of independently recognized, competence-based accreditation, consultancy and accredited training for clinical research professionals, offered comment the new EU regulation for clinical trials planned for implementation May 28, 2016.
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IAOCR, a provider of independently recognized, competence-based accreditation, consultancy and accredited training for clinical research professionals, offered comment the new EU regulation for clinical trials planned for implementation May 28, 2016.
Martin Robinson PhD, Executive VP & IAOCR Ambassador, commented, “These changes will work towards ensuring patient safety is at the forefront of clinical trials but the competence of those undertaking the trials is also required to ensure a robust, proficient and safe system is in place across Europe.”
The new regulation was approved by the European Parliament in April last year and has now been published in the official Journal of the European Union. It replaces directive 2001/20/EC – the Clinical Trial Directive which has been in place for almost a decade. The benefits associated with the new regulation include a single approval portal, standardized content of clinical trial applications, information about subject protection and informed consent, more stringent requirements for reporting trial progress and greater transparency about clinical trials. The regulation will be applied in full in all member states, with no need for separate national legislation and this will result in consistent and uniform application throughout EU allowing the EU Commission to conduct controls in Member States making sure that rules are properly supervised and enforced.
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