Before a new drug is approved for use by the Food and Drug Administration in the US, say for cancer treatment, it has to go through quite a stringent process of at least three phases of clinical trials, with each phase having a different purpose.
- Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Doctors also look for signs that cancer responds to the new treatment.
- Phase II trials test if one type of cancer responds to the new treatment.
- Phase III trials test if a new treatment is better than a standard treatment.
- Phase IV trials find more information about long-term benefits and side effects.
The Phase I trial stage is where a new treatment can get shut down quickly if it shows signs of causing harm. Phase II is meant to show that the treatment does work in the way advertised. Phase III can be a difficult bar to reach because you need to show that the new treatment is better than what is already available.
Nowadays most people think of these measures as reasonable precautions to prevent people from being harmed by untested drugs and other treatments. But as Dhruv Khullar writes, the idea that the government should be able to decide what people can put into their bodies has been, at least in the US, a controversial issue, and at one time there was nothing to stop people from doing whatever they liked. [Read more…]
