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- W49063008 abstract "This chapter is aimed at demonstrating how the new findings can serve to redesign the established clinical trial of new drugs, a model first developed in the 1950s. That earlier procedure only evaluates whether the putative new drug is superior to a placebo in reducing the severity of the disorder. The alternative “componential” paradigm provides a profile of drug actions, i.e., the timing and specific changes induced by the drug on the behavioral and mood components of the disorder. This chapter describes the componential trial comparing its advantages with the standard diagnostic model. Application of the alternative model in the late 1980s established its validity and contributed to refining current information on the onset of action and the actions of different classes of antidepressants. It is now possible to predict the patients’ clinical response based on reactivity to the agent during the first 2 weeks. Demonstrating that a drug’s efficacy can be tested within 2 weeks has been shown in several already reported studies. Reducing trials from 6 to 2 weeks can result in radically reduced costs for drug companies. In addition, the new componential paradigm for clinical trials makes detecting potential applications of the new agent for disorders other than depression, much easier to identify. It, thus, enhances basic research and drug development programs for pharmaceutical companies. These factors can contribute to eliminating the stalling of drug development that has occurred over the past decade. Practical details on these applications and the methodology are addressed." @default.
- W49063008 created "2016-06-24" @default.
- W49063008 creator A5010655140 @default.
- W49063008 date "2013-01-01" @default.
- W49063008 modified "2023-09-27" @default.
- W49063008 title "Developing a More Effective and More Efficient Clinical Trial Model" @default.
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- W49063008 doi "https://doi.org/10.1007/978-3-319-00389-4_8" @default.
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