The clinical trial industry loves to use and create acronyms. This poem provides an crash course.
Highly anticipated FDA draft guidance on Decentralized Clinical Trials has been released
The FDA finally released its draft guidance on Decentralized Clinical Trials (DCTs).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.
I have 2 dogs
What happens when 2 dogs compete for their human's attention?
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?
2023 Goals: The Long and the Short
What are your goals for 2023?
What I learned this weekend from teen athletes
I learned some valuable lessons from a talented group of teenage athletes at a recent volleyball tournament.
Do you have a monitoring policy and process for your clinical trial site?
The clinical trial monitoring visit can progress more smoothly if you have a monitoring policy and process for your site.