Outsourcing Research?
A Wall Street Journal article reports that many drug companies are going to Finland for drug research. It is thought that study subjects there are more compliant, with low drop out rates. We have heard of similar interest in India and China.
Most of the research is done by changing a single variable. For example, half the patients given a study medicine are compared to the half that are not given that medicine. We try to measure the effect of a medicine in real life scenarios; that is an interaction of medicine with how study subjects live, what they eat, how active they are, the air they breathe, their ethnic background, and much more.
We have now recognized that people can have unique response to disease and treatment based on their gender, ethnicity etc. Against that background, should we apply the research data obtained on a different population to the patients in the US? Should FDA approve the drugs for use in the US based on research done on subjects on another continent?
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Most of the research is done by changing a single variable. For example, half the patients given a study medicine are compared to the half that are not given that medicine. We try to measure the effect of a medicine in real life scenarios; that is an interaction of medicine with how study subjects live, what they eat, how active they are, the air they breathe, their ethnic background, and much more.
We have now recognized that people can have unique response to disease and treatment based on their gender, ethnicity etc. Against that background, should we apply the research data obtained on a different population to the patients in the US? Should FDA approve the drugs for use in the US based on research done on subjects on another continent?
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