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gingeranderson replied to the topic Discussion Topic: Having a "clinical background" in the forum Clinical Research Basics 7 years, 11 months ago
I think they should put more emphasize on just making sure the person can think critically and actually has a background in research. If you read publications such as “Embracing failure: What the Phase III progesterone studies can teach about TBI clinical trials”, you will learn about a particular example of a Phase 3 clinical trial that failed in my opinion, due to poor planning. This trial was a huge blow to the Traumatic Brain Injury research community. It planned to involve about 1,000 patients but they had to stop short due to the trial being that much of a failure. As outlined in the publication this was due to people not planning the trial reflecting the research that is already out there. It was almost like someone who had no actual background in research planned the clinical trial. It didn’t take any past research into account and of course, it was a complete and utter failure. I’m sure they had a CRA professional involved considering the size of the Phase 3 trial and the money spent and I think this is a prime example of people who might have the clinical background but couldn’t think critically through a problem and actually plan a trial that made sense. If they knew anything about TBI they would have known to separate patients by the way the TBI was induced. They would have understood that a different secondary biochemical cascade is initiated based on this and no, you can’t just treat every secondary biochemical cascade with the same drug.