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A sampling of global guidelines on the use of genomic biomarkers in drug development.
Success rates are higher for clinical trials that incorporate selective pharmacogenomics and pharmacogenetics (PGX) biomarkers, according to data from Informa's Trialtrove. Given the challenges of designing and administering trials to secure regulatory approval in areas of unmet medical need, the data provide some basis for optimism in realizing the promise of targeted, personalized therapies that improve health outcomes for individual patients.
The number of drugs in development for rare diseases have increased by 56%, with the number of rare diseases on the development map also increasing by 23% in just three years, demonstrating ongoing interest and seemingly increased enthusiasm for research within these areas of high unmet needs.
The development of new medicines is a high-cost, high-risk business with no guaranteed reward. To recognize those who have committed themselves toward this cause, Informa's very first Clinical Research & Excellence (CARE) Awards ceremony was held on 27 April at the State Room in Boston.
In infectious diseases, there were 239 Phase II to Phase III trials initiated during the period 1 October 2009 to 30 September 2010. The largest number of new trial starts was for influenza vaccines, both seasonal and pandemic influenza, which comprised 52% of all trial starts. Last year's H1N1 (swine) flu pandemic continued to drive vaccine development; 60% of influenza trials evaluated H1N1 flu vaccines. 63% of H1N1 flu trials started between October and December 2009, but tapered off before the official end of the flu pandemic in August 2010. Vaccine development in other diseases was also active, primarily for meningitis, HPV, HIV and HBV. Trailing behind vaccine development, HCV and respiratory infections had 30 and 29 trial starts, respectively. Of the 30 HCV trials, all but two were Phase II. As such, the upcoming year will be key for HCV as companies make decisions about drug development, more compounds move into Phase III, and results from ongoing Phase III studies are released. In respiratory infection trials, 10 new trials evaluated influenza treatments, corresponding with the strong response to the swine flu pandemic. 23 trials started in HIV, mostly evaluating already approved products in new dosing regimens and populations. New drugs included Gilead's Quad tablet (a fixed dose combination of four antiretrovirals), Panacos's first-in-class maturation inhibitor, and Bristol Myers-Squibb's first-in-class attachment inhibitor. Among trial starts for bacterial diseases, the most common were bacterial skin and respiratory infections.