British TaskForce Submits Recommendations for Phase I Guidelines
The Association of the British Pharmaceutical Industry (ABPI) and the BioIndustry Association (BIA) taskforce has established recommended guidelines to enhance patient safety in phase I studies with novel agents. The taskforce was created to address safety concerns following the events during the TeGenero trials with the immune stimulate TGN1412...
Specific recommendations included the use of an alternative dose assessment for certain novel agents, the administration of drug to only one subject on the first day, and the use of staggered dosing regimes. The taskforce also recommended better manufacturing controls to ensure quality, and the possibility of having some trials conducted in a hospital setting with access to intensive care facilities. The recommendations were submitted to Professor Gordon Duff, chair of the scientific expert group.
The 358-page interim report can be found on the ABPI's website in .pdf format.