To start a clinical trial, it is essential to obtain information about the physical, chemical, and pharmaceutical characteristics of the substance. This information is collected by performing pre-clinical research. During this research, the pharmacology, mechanism of action and toxicology is further explored. This can be performed on cells or animals. When a pre-clinical research is translated into a clinical trial, the drug in question must be safe enough to administer to humans and still provides the desired pharmacological effect.  

Translation of pre-clinical data to clinical protocol 

After a pre-clinical trial, the collected data must be translated into a clinical protocol. To do this, the data must be organized. This could be done with an investigator’s brochure (IB), investigational medicinal product dossier (IMPD), or study protocol. When translating it is important to consider the potential drug effects based on classification and drug target. But the key during the translation process is to always expect the unexpected.