Clinical trial recruitment timelines become impossible to meet when studies don't start on time.
Recruitment Timelines Not Met
Revolving CRAs
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).
A Physician’s guide to getting started in clinical research
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.
What’s the site cost of sponsor required portals?
There is a cost to sites for the portals that sponsors select for a clinical trial. That cost to the site can be in the thousands before a study starts.
Highly anticipated FDA draft guidance on Decentralized Clinical Trials has been released
The FDA finally released its draft guidance on Decentralized Clinical Trials (DCTs). Is it everything we've been waiting for?
The 4 “I”s of Investigator Motivation – Irritations
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.
The 4 “I”s of Investigator Motivation – Impediments
In the introduction to this series about Investigator Motivation, the connection was drawn between Motivation and Momentum. It’s a cyclical effect in clinical trials where one can influence the other both in negative and positive ways. When both Motivation and Momentum are low, we find sites silently quitting the study. What brings them to this point? One piece of the puzzle is to identify and eliminate impediments that prevent the study from functioning optimally.
The 4 I’s of Investigator Motivation – Introduction
A significant factor in recruitment for participants and conduct of clinical trials is Principal Investigator / Site motivation. A motivated investigator can motivate study staff and increase recruitment potential for a trial and decrease site related issues. Conversely, an Investigator or clinical trial site that is not motivated or loses motivation during a trial can result in recruitment slowing or completely halting. It is not uncommon for sites to silently quit studies they were once excited about. This series of articles will examine the 4 I’s of Investigator / site motivation and unpack what can be done to optimize clinical trial conditions.
Decentralized Clinical Trials – a site’s perspective
"Decentralized clinical trials" is the new buzz phrase in the clinical research community. The advancement of decentralized trials has been accelerated due to the pandemic and the need to do more remotely. As this new era dawns in clinical research, we need to exercise caution before diving headfirst.
Tools in Clinical Research
Sites use tools every day in clinical research. How do we take steps to ensure that tools work better for the people who have to use them?
Clinical Research 