September-October 2018 (Volume 19, Number 5) : PDF
The state of virtual clinical trials
Depending on the expert source considered, a clinical trial sector that eschews change will be dragged shouting and stomping into the realm of virtual trials. By contrast, a clinical trial sector that is forward looking is perusing medical mobile device apps and reading Fitbit instructions while you are reading this sentence. The closest reality for the state of virtual trials in clinical research is a bit of both. It is a bit of a hazy landscape, as the few research studies that have been done on the efficacy of virtual trials involve small sample sizes or have only recently been announced and started.
What to expect during an FDA GCP/BIMO inspection
FDA regulations governing clinical trials establish responsibilities for clinical investigators (i.e., the principal investigator or PI), sponsors, and institutional review boards (IRB) for ensuring the proper conduct of the trials and the protection of the rights and welfare of subjects enrolled in the trials. This article focuses on good clinical practice (GCP) inspections of the PI and the sponsor. It also updates similar such articles printed in the past.