Quality by Design aspects applied to Clinical Study Protocol Development
Clinical Study Protocols are the prospective blueprints for the execution of a scientific experiment involving human subjects. A clinical study intends to answer a scientific question and aims to contribute with new information to the current knowledge base in the medical / scientific community. Such knowledge can be used by regulatory agencies in their decision to approve a new drug, by medical associations to feed into revised treatment guidelines, or - if they are hypothesis generating rather than confirming - as a basis to plan further experiments.
A clinical study always poses a certain risk to participants, because - by definition - not all positive or negative effects of the study drug are well known and understood (if they were, the