The purpose of the guidelines is to provide an up to date reference source for those conducting phase 1 trials.
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 requirement.
Stephen Whitehead, Chief Executive of the ABPI, said:
“In 10 to 20 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.”
'Guidelines for phase 1 clinical trials' is available for download here.
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Notes to editor
The ABPI represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK.
Our industry, a major contributor to the economy of the UK, brings life-saving and life-enhancing medicines to patients. Our members supply 90 per cent of all medicines used by the NHS, and are researching and developing over two-thirds of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases.
The ABPI is recognised by Government as the industry body negotiating on behalf of the branded pharmaceutical industry, for statutory consultation requirements including the pricing scheme for medicines in the UK.