MANFRED STAPFF
Actavis plc, Quality Management Systems, Standards & Training, Jersey City, NJ, USA
Quality by Design aspects applied to Clinical Study Protocol Development

INTRODUCTION
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 study would not be necessary!). Consequently, a clinical study can only be justified from an ethical point of view, and can only be lawful (among many other legal prerequisites), if the potential benefits overweight the potential risks. Often it is primarily the medical and scientific community who will benefit from a clinical study, (e.g. by gain in knowledge), rather than an individual study par ...