Pre-Clinical Studies - the need for VICH GCP compliance?

Pre-Clinical Studies - the need for VICH GCP compliance?

Pre-clinical studies in veterinary clinical trials defined:   

Also called ‘non-clinical’ studies these studies precede clinical studies; usually in vitro and in vivo (animal) studies, where different aspects of the test product, including safety and efficacy, are evaluated. These pre-clinical studies usually are the first time the product is evaluated for effectiveness in the target species.

Is VICH GCP compliance needed?

Technically, not all pre-clinical studies have to be performed to VICH GCP. 

However, VICH GCP can apply to all studies, in the introduction to VICH GCP it states that it can be applied to "all clinical studies of veterinary products in the target species".

The idea behind VICH GCP is promoting a high-quality standard to the conduct of running a study. Thus, ensuring a robust and valid data set which will hold-up against any regulatory inspection. 

Having said that, please note that pre-clinical studies are mostly performed at or by facilities which have other internal standards, such as GLP. More facilities like these are adopting levels of VICH GCP into their setting. When their internal systems do not allow this then the study will be run to the "spirit" of VICH GCP. These additional system requirements include a greater focus on data validation and quality control.

It would be recommended for consideration by the Sponsor that if the study is considered pivotal then it is performed to VICH GCP. So, for a dose confirmation study - this would be performed to VICH GCP. However, if the study is for proof of concept or perhaps a "dose finding" study then perhaps you can set aside VICH GCP if you are assured of the systems and checks in place to record and report the data in a valid manner and to other quality standards.

Concluding Remark:  Ultimately it is up to the Sponsor to determine the quality standards applied to each individual study and have this balanced against other factors such as cost, facility/ CRO availability and facility/CRO documented quality standards.

As Sponsor it would be recommended that a qualification audit of the facility/CRO is conducted ahead of the study and that a data management plan, audit plan and monitoring plan is utilised to ensure all parties know the level of data recording, QC, validation and QA expected at each stage of data handling.

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