How is clinical study patient selection criteria determined?

In this video Rachel interviews Professor Carolyn Young who is a Consultant Neurologist. The interview was filmed by Millar

Video transcript

Rachel: Hi there.  Today I’m speaking to Professor Carolyn Young who’s a neurologist at the Walton Centre in Liverpool and who’s been a principal investigator on about 40 MS clinical trials.  

 

How much does clinical trial study selection depend on preliminary evidence that suggests a drug is more likely to succeed with people that fall within a well-defined group?

 

Carolyn Young, Consultant Neurologist: So for Phase III trials of course it’s not known whether the drug has any true efficacy, that’s the aim of the study, so it’s not so much that they’re selecting for people in whom they think it works, it is that they are making exclusion criteria to not include in the study, either people who won’t be informative to the end point or who may be at greater risk, predicted greater risk from taking part as a volunteer.

 

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