ABPI publishes Guidelines for Phase 1 Clinical Trials

Published: 14-Aug-2012

Updates previous 2007 version to reflect regulatory changes


The Association of the British Pharmaceutical Industry (ABPI) has published an updated version of its Guidelines for Phase 1 Clinical Trials.

Phase 1 clinical trials are conducted for experimental research purposes, and are a key step in the process of discovering and developing new medicines.

Last published in 2007, the Guidelines have been updated to reflect changes in the regulatory arena – particularly as a considerable amount of what previously constituted guidance has now become a legal requirement.

In addition to recent regulatory changes, the new edition contains the latest ABPI guidance on insurance and trial subject compensation.

Stephen Whitehead, chief executive of the ABPI, said: “Ten to twenty years from now there will be a whole raft of innovative new medicines saving and improving patients’ lives as a result of the experimental research taking place today. In Phase 1 research, which represents the link between scientific research and clinical medicine, the highest possible level of knowledge, standards and skills must all be brought together.

‘The ABPI has produced these Guidelines to help support and simplify the critical role of Phase 1 research, while helping researchers ensure their work is conducted with the highest possible level of efficacy and safety.’

The Guidelines for Phase 1 Clinical Trials are available for download on the ABPI website.

You may also like