It's time for clinical trial sponsors and CROs to recognize that sites should be compensated for monitoring visits. Sites are increasingly asked to do more in clinical trials and the study budgets haven't increased with the additional responsibilities.
Completing a feasibility questionnaire for a clinical trial is a critical process on the path to site selection. Take the proper steps to turn the feasibility questionnaire into selection for a study.
Recruitment in clinical trials is in crisis. Most trials don't meet their recruitment targets on time. One reason for this is the industry's short term approach to recruitment. Recruitment is only contemplated one study at a time when it should be approached as a long term plan.
The negotiation of a clinical trial budget should commence during the feasibility questionnaire review and continue through pre-study visits using planned communications.
Clinical trial recruitment timelines become impossible to meet when studies don't start on time.
There's a cost to the clinical trial site each time the CRA changes. With the current state of sponsors and CROs, CRA changes seem to happen with increasing frequency. Sponsors and CROs need to work to decrease the impact CRA changes have on a site (and compensate the site for the additional work).
Getting involved in clinical research can be challenging. Many new investigators struggle for years to get a clinical research business off the ground. Once they participate in their first study, it may not be what they expected, and they abandon clinical research altogether. This article seeks to inform potential investigators and sites and provide guidance on next steps.
Someday soon, the stickies that CRAs use will be a thing of the past. We'll reminisce about the good old days when the patient's paper clinical research charts were full of stickies... or maybe not.
The FDA finally released its draft guidance on Decentralized Clinical Trials (DCTs). Is it everything we've been waiting for?
The last post in this series focused on the Impediments in clinical research that affect Investigator Motivation and ultimately, Momentum in a clinical trial. Those impediments obviously can be irritants, but there are many other things that result in site irritation. Don’t underestimate the effect that irritations can have on a clinical study and the reaction that can result from sites. When you’re out for a walk and a single raindrop falls, you might not think too much of it or change your path. If the volume picks up and becomes a deluge, you’re going to react (at least I hope you do). Investigator Motivation decreases in a clinical trial long before the irritations become a storm.
Clinical Research 