Let’s talk clinical trials – a TASK Academy series – #2
I cannot help but smile when I think back to a curriculum vitae we once received in reaction to an advertisement we posted to recruit an investigator at TASK.
TASK was still a small clinical trial company back then and we did not have a human resources team yet, so I used to help sift through all the CV’s received. My eye caught the cover letter of one application reading “I will be a perfect candidate for this job since I have more than 10 years’ experience as a private investigator”.
Who remembers the American crime action-drama television series with Thomas Magnum P.I. played by Tom Selleck back in the 80’s and more recently played by Jay Hernandez in 2018? Now Magnum was a proper private investigator (P.I.) who went all over Oahu, Hawaii, solving crimes in his red Ferrari and clashing with stuffy British butler Higgins and his two dogs.
Unfortunately, our advertisement was not seeking the likes of a “Magnum P.I.” but a doctor / physician to work at one of our clinical trial sites.
So then, why on earth do we call a doctor working in clinical trials an investigator, you might ask. Are they also solving a crime? I have never asked myself that question – until that day the private investigator applied.
Wikipedia indicates, “A clinical doctor involved in a clinical trial is called an investigator and is responsible for ensuring that an investigation is conducted according to the signed investigator statement / agreement and the investigational plan, and applicable regulations; protecting the rights, safety and welfare of subjects under the investigator’s care….”
I would like to add to Wiki my reasoning, in the attempt to maybe “justify” why a doctor is called an investigator. The whole aim of a clinical trial is to show that the “compound or device under investigation”, what we call the investigational product (IP), is safe to use in humans and is effective, in other words it is doing what it is supposed to do. It’s safety and efficacy still need to be investigated. The person leading the group of people, and under whose immediate direction the IP is dispensed to a subject is called an investigator – and that is always a qualified doctor, physician or scientist with additional certification to enable them to act as investigators.
In South -Africa we call the lead of a clinical trial team the principal investigator (P.I.) – and that is how the private investigator made his honest mistake.
“The investigator has a different role to a physician or general practitioner and numerous responsibilities within a clinical trial setting, but more about that later!”
Head Quality Assurance and Regulatory, Founder TASK Academy
With years of hands-on experience and under the leadership of Karen Cloete, TASK Quality and Regulatory team ensures high-quality standard and GCP compliance of all trials conducted at TASK. They also offer consulting services to sponsors and sites – feasibility assessments, site start up support, regulatory submission support and clinical trial auditing (GCP / GCLP and vendor audits). Through the academy training and capacity development services are also be provided