Practical Pointers for Drug Development and Medical Affairs

Abstract

It is absolutely an essential part of the clinical research process in providing informed consent, and having the potential participant sign the forms (ICF).1 It may help foster enrollment by also explaining to potential study participants not only why the research is being conducted, but also how their individual participation will help in product development and what this product has the potential
to accomplish. It is more difficult than ever to enroll patients in Phase I oncology clinical trials.2 One partial solution, when feasible, is to make this a multi-center semi-decentralized clinical trial rather than one inhouse unit.