Bishal Gyawali provides an introduction to clinical research and the different phases of clinical trials.
Hello, everyone. Welcome to the first video in this series. As I mentioned in my introductory video, we are going to focus first on phase 3 clinical trials , and then we'll move on to other phases of clinical trials and other types of clinical research . Just to give you some introduction, what is a phase 3 clinical trial?
A clinical trial, fundamentally or classically, can run from phase 0 to 4. Phase 1 is the first phase of the clinical trial that is actually done in human beings. Then, we go to 1, 2, and 3. Phase 3 is usually randomized, so whenever we are referring to a randomized, controlled trial, it's usually a phase 3 randomized trial. Phase 4 is postmarketing, postapproval, real-world collection of evidence. We'll skip phase 0 and phase 4 for now.
Once we have proven that the drug is safe in phase 1, we take it to phase 2. In phase 2, we ask if this drug actually works — what that means for cancer is whether it shrinks the tumor, for example. In phase 2, we are not asking about the effectiveness of the drug in terms of what we already have. We are not comparing it with anything.
Most of the drugs fail in phase 1, then they fail in phase 2. I guess it's understandable because phase 3 is a randomized trial, and we do a randomized trial when there is clinical equipoise, so almost 50% of the trials fail in phase 3. After that limited sample size, in phase 2, when we are testing whether the drug works, we have a larger sample size. Then in phase 3, we have an even larger sample size. The sample size increases from phase 1 to phase 2 to phase 3.
Also, in terms of regulatory approval, classically, drugs are supposed to be approved after showing that they are better than what we already have, which is a phase 3 trial. Nowadays, as you all know, in oncology, we have seen several drugs approved on the basis of the phase 2 trial itself, which is a change from the classical paradigm. We'll discuss this in the future.
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