Clinical Trials 101: Dr. Vallerie McLaughlin

Clinical Trials 101: Dr. Vallerie McLaughlin


hi I’m Valerie McLaughlin a cardiologist at the University of Michigan and today I’d like to talk about the different phases of clinical trials clinical trials can be divided into a number of different phases a phase one trial is usually a trial in healthy volunteers to get some information about the dosing of a drug and about the side effects that might be expected with the drug a phase two trial is often called a proof-of-concept trial it’s usually a smaller trial in patients with that disease to get information about how effective the drug is to treat certain parameters of that disease safety is monitored all the way along and a phase three trial is what we call a pivotal trial it’s usually a larger trial that has a clinically meaningful endpoint that the FDA will accept to approve a drug and of course safety is monitored throughout a phase three trial is what the sponsor goes to the FDA with to get approval for that agent phase one trial is usually in healthy volunteers to learn about the dosing and side effects a phase two trial is a small trial in patients to really test whether this drug could be effective in that disease a phase three trial is a large trial in the disease to determine if the drug is effective and this is usually what’s done for FDA approval and a phase four trial is done in drugs that probably have already been approved to look at other indications or other scenarios for the drug clinical trials are important and necessary to help further the therapies that we have available for many different diseases the only way to get a drug or device or another intervention approved is to do a clinical trial to demonstrate that the drug works I’m Valerie McLaughlin and I’m aware that I’m rare

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