18 February 2015
5 Reasons to Test Cognitive Effects in Early Phase Clinical Trials
With cognitive assessments becoming an increasingly routine component of drug development programmes Dr Charlotte Housden, Scientist and Product Manager at Cambridge Cognition, gives five reasons why it is beneficial to test for cognitive effects in Phase I clinical trials.
With cognitive assessments becoming increasingly a routine component of drug development programmes Dr Charlotte Housden, Senior Scientist and Product Manager at Cambridge Cognition, gives five reasons why it is beneficial to test for cognitive effects in Phase I clinical trials.
1. Avoid costly late stage failure
If serious negative cognitive effects are identified in Phase I, drug development can either be stopped or closely monitored, reducing the risk of costly late stage attrition.
2. Meet FDA reviewer guidance
As all compounds that cross the blood-brain barrier, as well as those that can have an indirect effect on brain function (for example through modulation of glucose levels), can have a deleterious effect on cognition, it is responsible to check for adverse cognitive effects. By doing this your clinical trials will be in line with FDA reviewer guidance that states that data submissions that include special studies that identify adverse effects, such as decreased cognitive function, will be given more credence than those which do not. Therefore, measuring cognitive markers from an early phase of drug development could help to accelerate the approval process.
3. Collect valuable drug dose information
Phase I trials typically assess the widest range of drug doses, allowing collection of valuable information about dose-related changes in brain function and informing decision making regarding the cognitively-safe dose range to use for the rest of the development programme.
4. Improve decision-making for similar compounds
By conducting cognitive assessments in Phase I, decision making about other similar compounds in preclinical can be enhanced. Specifically, any information about the cognitive effects of compounds in Phase I, whether positive or negative, can help to decide whether other compounds should be bought forward from preclinical testing.
5. Superior monitoring of cognitive effects in later phases
If unwanted cognitive toxicity effects are identified in Phase I, but development continues, these risks can be flagged and can be monitored in later phases, or when assessing real-life cognitive effects.
Alternatively, monitoring cognitive effects and demonstrating the superior cognitive safety profile of your compound compared to existing compounds will provide you with valuable competitive differentiation.
Notes and References:
1: Food Drug Administration Center for Drugs Evaluation Research (2005). Review Guidance: Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review, FDA Maryland
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