Integrating data from the IMPD/IB. A new tool for translational integration of preclinical effects.

The first administration of a new compound in humans is an important milestone. A major source of information for the researcher is the 'investigator's brochure' (IB). Such a document, has a size of several hundred pages. The IB should enable investigators or regulators to independently assess the risk-benefit of the proposed trial but the size and complexity makes this difficult. This article offers a practical tool for the integration and subsequent communication of the complex information from the IB or other relevant data sources. This paper is accompanied by an accessible software tool to construct a single page colour coded overview of preclinical and clinical data.