Pre-Clinical Vs Clinical Data
Pre-clinical data are the vital testing and safety data collected during the research stage before the clinical trials begin. Tests like in-vitro tests, ex-vivo tests, biological evaluation, simulated use, engineering, performance tests, animal tests, computer modelling, lab tests, stability, shelf life etc. come under pre-clinical tests.
Clinical data are used to prove the safety and performance of the device in question. The manufacturer can obtain the data through clinical trials or scientific literature. Scientific literature can be about the actual device, equivalent or similar devices.
Pre-clinical tests also include:
- Experimental data regarding design calculations.
- Intended use.
- Mechanical or electrical tests.
- Reliability tests.
- Evaluation of biocompatibility and published literature applicable to the device or similar device.
Pre-Clinical data, as the name, defines any experimental data before clinics, which means safety and testing data collected from the stage of research that begins before actual trials can begin in humans.
Clinical Data is data from experiments conducted on humans for various objectives like safety, efficacy, etc.