July 12, 2011 11:08 ET

Toxicity & Serious Adverse Events in Late Stage Drug Development Are the Major Causes of Drug Failure

ROCKVILLE, MD--(Marketwire - Jul 12, 2011) - has announced the addition of the new report "Top R&D Drug Failures - Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure," to their collection of Pharmaceuticals market reports. For more information, visit

This report discovered that the economic impact of drug failure during late stage development increased in relation to the escalating cost of development for new therapeutic agents. The main cause of drug failure in Phase III, when the efficacy of the drug is already evaluated, is either its safety measures or its ability to demonstrate any additional benefits in a larger population over a longer time period.

Pharmaceutical companies have recently invested substantial amounts of money in R&D processes; in order to combat the threat of patent expires of blockbuster drugs, and to increase the chances of discovering a drug which could generate considerable revenue for the company. If a drug receives approval and is patented, companies' returns are significantly higher than the amount invested in R&D.

The attrition of molecules occurs at various stages of the trial during drug development process. The majority of molecules fail at the initial stages of development, such as pre-clinical studies and Phase I and II. Pharmaceutical companies face huge losses when drugs fail in the late stage of trials, such as Phase III and the post-marketing stage.

According to analysis conducted during 2005-2010, it was found that the number of drugs dropped from the pipeline increased from 2003 to 2007 and furthermore decreased from 2007 to 2010. Many drugs have been discontinued during the course of clinical trials, due to safety and efficacy issues.

The decision to discontinue the development of a drug is taken by the health authorities and is based on interim analysis. If the drug is not able to demonstrate any additional benefits over existing therapies, or it has issues related to patient safety, the drug fails to receive approval from health authorities.

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