Elsevier has announced the launch of a new module in PharmaPendium, its database of drug approval documents and extracted data to inform critical drug development decisions.
The PharmaPendium Efficacy Module features more than 1.4 million extracted efficacy observations from FDA and EMA drug approval packages, providing insights to researchers to support clinical development decisions and clinical trial design.
Failure rates for Phase I and Phase II clinical trials range from 35 to 57 per cent; a lack of efficacy is one of the most common reasons for continued late-stage trial failures, followed by a lack of drug safety. The data in the PharmaPendium Efficacy Module helps researchers to improve translational research (from animal to human) which enables researchers to predict human outcomes with greater confidence, resulting in more informed clinical trial study designs.
'Getting a single drug to market can cost billion dollars and takes up to 15 years - a large part of this cost can be attributed to drugs that fail,' said Jaqui Hodgkinson, VP product development life sciences, R&D Solutions, Elsevier.
'Improving translational research and increasing the success of clinical trials will not only help to reduce the costs of clinical development but also improve the overall efficiency of research. Comparative efficacy data that includes both preclinical and clinical observations is hard to find; with this new PharmaPendium module, data across entire drug and target classes is now more accessible to researchers.'