Rationale for Conducting a Pilot Study Prior to a GLP Preclinical Study
Feb 02, 2015
Many companies setting out to perform Good Laboratory Practice (GLP) studies want to proceed directly into their GLP preclinical study without conducting a preclinical pilot study first. While, this may make sense in some situations, many times it can introduce more challenges that can be mitigated if a small efficient preclinical pilot study is conducted first.
The general scientific rationale for conducting a focused non-GLP preclinical pilot study prior to the conduct of a pivotal GLP preclinical study is to establish, transfer, or in some instances validate nonstandard procedural methodologies associated with a test device (or test article) that are important to the success of the pivotal GLP preclinical study. Examples would include:
- When a study requires using a novel or specific surgical methodology not routinely used at the test facility;
- When a potentially major design or material modification has taken place with a test device following previous non-GLP evaluation;
- Instances where a test device (or test article) has not been previously evaluated in an animal model (or particular species);
- When novel primary protocol specified critical endpoint analyses are to be conducted at the test facility or subcontracted test sites;
- If the technical study conduct involves working with new consulting study personnel that have a major responsibility for the success of the study (surgeon or principal investigator at a subcontract analysis facility).
In many instances the preclinical pilot study is intended to generate biologic samples that are used to generate preliminary endpoint results or are used to establish/validate specific analyses techniques that will be required for the analyses of samples generated in the pivotal GLP preclinical study. Frequently, long term pivotal GLP studies can be initiated following the successful completion of the establishment, transfer, or validation of the in-life methodology (surgery, sample collection, etc.) but prior to the completion of the sample analyses of the pilot study. It should be noted, that even if the results from the pilot preclinical study are successful, the FDA will typically still require a GLP preclinical study for submission to provide safety data.
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