Why should you care about this review site?
I want to address something critically important and how we, as clinical operational managers can truly make a positive impact to the results of our clinical trials.
…Why do promising clinical trials fail?
Current studies show the rate of failure in pivotal studies to be significant; currently at about 45% (1). Of course I am no statistical expert, nor am I an expert on biologics, establishing endpoints, novel vs. known mechanisms of failure, randomization, inclusion of biomarkers…and the list goes on. BUT, I can share with you what I have seen in operations which will contribute to this failure rate.
And the good news is I will only focus on what we, as clinical trial operational managers, can control.
Our team members…
As I am sure you will agree, high attrition rate of your clinical staff can be the death of your trial. Additionally, team members who are not at the appropriate skill level (both medical/technical and the harder to come by “soft skills”) can wreak havoc on your monitoring plan or the quality of data being collected.
…So why did I build this website?
A little about me: My name is Fred Elmore and I am a Clinical Operations and Quality Assurance Professional with over 20 years’ staff management experience in quality assurance, records management, general clinical research and training development.
I have seen a concerning trend within clinical trials that I believe we can address through minor changes in the way we attract, select, and on-board clinical staff. Many sponsors and CROs use recruiting companies to source both permanent and contract staff members and honestly I believe that is the right approach if you are using the right clinical recruiting company.
This website is intended to provide feedback from my experiences and research and hopefully will help you make better partnership and hiring decisions.
Please feel free to contribute your insight and opinion to the articles and reviews. And if you have any ideas on new content please reach out to me.
(1) Kola I and Landis J: Can the pharmaceutical industry reduce attrition rates. Nat Rev 3: 711-715, 2004