As clinical research studies are continuing to shift south and east, it's easy to accept this trend as a fait accompli. But AstraZeneca's recent experience with Brilinta shows that you don't have to be a contrarian to question this trend.
A couple of weeks ago, the U.S. Food and Drug Administration has extended the time to finish reviewing the NDA for the blood thinner. The company said FDA needed more time to study the application. However, observers quickly pointed out that the drug was significantly less effective in the U.S. than outside the U.S., and that this may be the cause for the delay.
In fact, the WSJ Health Blog's recent question Why Does AstraZeneca's Brilinta Seem to Work Only Outside the U.S.? was far from academic. As clinical trials become global in nature, sponsors need to accept the fact that positive results could come from only certain countries - or from many countries but not from an important one.
Will this dampen the enthusiasm around international clinical trials? Probably not. And in the mean time, AstraZeneca is happy that Brilinta is moving along in the regulatory approval process in Europe...
Here are three more articles on the topic:
- Global clinical research is unethical. Or a business necessity, depending on who's asked.
- Overseas clinical trials - appalling or good business?
- PatientsLikeMe making clinical research obsolete?
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Categories: clinical research