NEW YORK, October 1, 2015 /PRNewswire/ --
The addition of efficacy data from FDA/EMA drug approval documents helps to improve clinical and translational study designs and facilitate development decisions
Elsevier, a world-leading provider of scientific, technical and medical information products and services, has announced the launch of a new module in PharmaPendium, its fully searchable database of drug approval documents and extracted data to inform critical drug development decisions. The PharmaPendium Efficacy Module features over 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.
The failure rates for Phase I and Phase II clinical trials range from 35% to 57%; 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."
The PharmaPendium Efficacy Module helps researchers quickly find relevant comparative information by enabling them to search on an indication and/or endpoint of interest. It features the most in-depth efficacy database on FDA and EMA approved drugs, where information such as indication tested, sample size, primary or secondary endpoints, study design, and age groups, can be easily searched and filtered on to get critical insights which can improve clinical trial design and mitigate the risk of clinical failure.
For more information, please visit http://www.elsevier.com/solutions/pharmapendium/efficacy-module
PharmaPendium offers dedicated data modules that provide insights and information on the critical focused areas of drug development including drug safety, ADME and drug-drug interactions and contains text searchable source documents; FDA and EMA drug approval documents; FDA AERS; FDA advisory committee meetings and selected journals. Its extracted databases, excerpted from drug approval documents, provide exportable data on drug efficacy, drug safety, pharmacokinetics and metabolizing enzymes and transporters, across preclinical, clinical and post-market stages.
PharmaPendium® and the PharmaPendium® trade mark are owned and protected by Reed Elsevier Properties SA and used under license.
Elsevier is a world-leading provider of information solutions that enhance the performance of science, health, and technology professionals, empowering them to make better decisions, deliver better care, and sometimes make groundbreaking discoveries that advance the boundaries of knowledge and human progress. Elsevier provides web-based, digital solutions - among them ScienceDirect, Scopus, Elsevier Research Intelligence and ClinicalKey - and publishes more than 2,500 journals, including The Lancet and Cell, and more than 33,000 book titles, including a number of iconic reference works. Elsevier is part of RELX Group plc, a world-leading provider of information solutions for professional customers across industries. http://www.elsevier.com
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