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CNS Trials Almost 15% of ALL FDA-Regulated Clinical Trials in 2007--PAREXEL Report
Clinical studies for neurology drugs represented 8.9% percent of all FDA-regulated clinical trials in 2007, according to a new study released in PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook. The study also found that trials for psychiatric therapies comprised another 5.5% of studies regulated by the FDA.
Growth in the numbers of active research projects in both neurology and psychiatry each surpassed the 8.3% overall growth for FDA-regulated trials. In all, there were 425 active commercial investigational new drug applications (INDs)--applications under which clinical trials are actively being conducted--for neurology drugs in January 2007, up 9.3% from 2006 levels. Meanwhile, the number of active INDs for psychiatry drugs was up 10%, to 264.
Overall, there were 49 clinical research starts for neurology drugs in 2006 as measured by commercial IND submissions to the FDA. In contrast, there were 29 clinical research starts for psychiatry drugs.
While industry's submissions for clinical research in the CNS area remain strong, it is important to note that high percentages of CNS trials continue to be delayed by the FDA, something that is not surprising given the nature of the research. Of the 49 commercial IND submissions for neurology trials in 2006, for example, the FDA placed a clinical hold on 43% of the applications, the highest for any area. The FDA uses clinical holds to delay proposed or discontinue ongoing trials based on safety-related or other concerns.
Source: PAREXEL's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008 www.barnettinternational.com.