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The EMA/CVMP Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs and its practical implementation

With effect of 1AUG2014, the updated guideline came into force in the EU. NSAIDs are characterised as substances that can be defined by clinical-chemical tests ex vivo for their ability to inhibit isoforms of the enzyme cyclooxygenase, which catalyses the conversion of arachidonic acid into prostaglandins and thromboxane in vivo. The guideline may be extended to studies aimed at demonstrating efficacy of similar anti-inflammatory agents. The scope of the guideline is to provide guidance on trial design and conduct, as well as on reporting standards for efficacy studies submitted to regulatory authorities. Clinical studies should be planned based on the route of administration, dosage, frequency and duration of administration. General requirements include randomisation, blinding, analytical and statistical methods and GCP or GLP compliance. Pharmacodynamic and –kinetic data on the active substance are considered important and PK/PD can be an aid to establish the dosing strategy. The selection of relevant primary and secondary endpoints is paramount for pivotal efficacy studies, which should be based on clinically relevant objective measurements. However, as objective endpoints are often missing, subjective assessment methods may be acceptable provided that their validity can be justified. Rating scales are a relevant approach, but validated methods are present in few species and indications. The guideline describes prerequisites for rating-methods to be accepted. Primary endpoints should be supported by secondary endpoints and be feasible for laboratory and field conditions and be ethically acceptable in EU. Non-inferiority and superiority study designs may be acceptable, if justified. Species examples will be given. References: 1. EMA/CVMP/EWP/1061/2001: Guideline for the conduct of efficacy studies for non-steroidal anti-inflammatory drugs

DATE » 19.05.2015

AUTHORS » Hellmann, Klaus; Caroline Zauter

PUBLISHED » Proceeding of the 19th Biennial Symposium of the American Academy of Veterinary Pharmacology and Therapeutics, Fort Collins, Co. USA
May 17 - 20, 2015, Poster 5