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.