A proposed clinical trial model: analyzing the CT process

Over the past 15 years, methodology and ethics have become important issues in the design and conduct of multicenter clinical trials. Nowadays, clinical research embraces very different disciplines, such as information technology, regulatory affairs, quality assurance, and economics, and it is associated with a complex regulatory framework. The recent EU Clinical Trials Directive has added even more to this complex framework. All of this makes clinical research a more complicated process, and this translates into a difficult planning phase, increased trial time, increased costs, and additional energy.