New GHTF (Global Harmonization Task Force) clinical evidence working group makes speedy progress

Considerable progress has been made by the new Global Harmonization Task Force (GHTF)working group dealing with clinical evidence, since its inaugural meeting on January 17-18. Study group 5 has the aim of ultimately harmonising principles to determine when a clinical investigation, as opposed to other forms of clinical evidence, is needed, an issue of key concern globally, and particularly in the EU at present. According to the minutes of the May 9-10 meeting in London, UK, just posted on the GHTF website, members of SG5 had successfully spent the intervening five months: researching the existence of any differences in key definitions in terms used in the area of clinical evidence in documents worldwide, with an aim of drawing up new, harmonised global definitions; considering the overlap between its work and that being conducted in the context of clinical evaluation standards; and developing draft guidance on clinical evaluation.