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| Issue 4 - October 6, 2009 Drug development is a challenging proposition. That has never been truer than now, due in part to the plethora of potential targets for drug action discovered through molecular biology and particularly the human genome project. The main consequence of the human genome project has been said to have been to increase the “burn rate” of drug development. That is particularly the case in neuropsychiatric drug development because the knowledge of the pathophysiology has lagged behind the identification of new potential targets for drug action. There is the need for increased efficiency in the approach to developing such drugs, particularly early in the process. This includes the use of tools to determine whether the drug makes it into the brain and the use of participants with the target illness early in human testing. Also needed are better tools to decide what doses to study in phase II and the use of adaptive trial designs to more completely and efficiently determine the dose-response curves of the drug or whether to terminate proof-of-concept studies early for either success or failure. In previous issues of this newsletter, we have focused on the special populations available at the Clinical Research Institute to accelerate the study of investigational drugs into patients early in human testing. We also have extensive experience with computerized neuropsychological testing for cognitive function, reaction time, driving performance and electroencephalographic physiological measurements which correlate with improvement in cognitive functioning. We will be presenting at the American College of Neuropsychopharmacology (ACNP) on the results of just such an early-phase study to examine the ability of a novel mechanism of action drug to improve functioning in patients with cognitive impairment associated with schizophrenia. In the next issue of Invenio, I will discuss applying adaptive design approaches to early-phase studies to efficiently but extensively examine the dose-response properties of a new drug and to determine whether to end an early phase study early either for success or futility. If you are interested in how these tools and approaches can assist you in your drug development endeavor, I would be happy to discuss the matter with you. |
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