ABPI publishes new phase I clinical trial guidelines

The Association of the British Pharmaceutical Industry (ABPI) has published updated guidelines on experimental phase I clinical trials.

Providing an up-to-date reference source for companies carrying out early-stage clinical studies, the guidance has been upgraded for the first time since 2007 and reflects the significant changes in the regulatory arena that have taken place.

In particular, the new publication will highlight issues that were previously considered to be recommendations, but are now legal requirements.

According to the organisation, phase I research requires the highest level of standard and skills to be applied, due to the essential role these studies play in linking scientific research and clinical medicine.

Stephen Whitehead, chief executive of the ABPI, said the guidelines will "help support and simplify the critical role of phase I research, while helping researchers ensure their work is conducted with the highest possible level of efficacy and safety".

Earlier this month, the organisation appointed leaders from a number of leading pharmaceutical companies to negotiate the new UK medicines pricing scheme.