Clinical Drug Trial Participation: Is it Parallel to the Pace of Pharmaceutical Drug Development?

Dr. Schilling, let’s talk about the pace of research. So first of all if we don’t get enough participation in trials How does that slow drug development? well, it slows it down and normally because you know we have to have a certain number of people in each trial to be able to get a reliable answer and These days it’s becoming even more challenging because as we’re developing drugs and only target a specific genetic Abnormality in the tumor which sometimes is very rare so we may be looking for a genetic abnormality that Only occurs in 2 or 3% of all people with a certain kind of cancer First you have to find the people who have that genetic abnormality Then you have to be able to enroll them in the clinical trial They have to be willing they have to meet the enrollment criteria so it can take a long time and even a global effort to Find enough people to fill out a clinical trial and most clinical trials in order to produce a reliable Result are going to require a minimum of 50 to 100 patients some require many hundreds of patients or even many thousands of patients depending on the question being asked so you can see if People are not participating. It’s going to take a long time to get those answers Now male you got Gleevec in a trial at least three years before it was approved and it was approved fast Because it was such a breakthrough right says you literally got tomorrow’s medicine today and it saved your life in the process Yes, because I was past the three years I was like three years and eight months of my diagnosis. So he had another three years on to that and You know, I would not have been here And in my case, I was in a trial Related to chronic lymphocytic leukemia three drug combination and I received that in a Phase two trial ten years before that that was You

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