With vaccines and drugs for the coronavirus already entering human testing, it is important to know what the different phases of clinical trials are testing for.
At this point, the researchers will use all the information they have gained to design the phase 3 trial. They decide what measures to use, the doses to test and the type, orIf there is evidence in either phase 1 or phase 2 that the drug or vaccine is unsafe or ineffective, the teams will stop the trial.Phase 3 trials are where researchers look to see if people that get the treatment are statistically better off than those don’t.
In order to get statistically meaningful data, phase 3 trials are big, normally including a few hundred to 3,000 people. This is the final step before a drug is approved for public use. After a phase 3 trial is finished, the FDA puts together a panel of independent scientists to review the data. The panel decides, based on evidence of success and prevalence of side effects, if the benefits of the drug outweigh the risks enough to approve it for widespread use.Phase 4 trials are used to test approved treatments for the same medical condition but in a different dose or time frame or group of people.
When a drug that’s been approved for one purpose is studied for a different medical condition – for example, testing the malaria drug hydroxychloroquine as a potential treatment for COVID-19 – this is not a phase 4 trial. This is a phase 2 or 3 trial because it is designed to answer those early questions about how well the treatment works for the new condition.. It’s easy to get excited when reading about a new drug or vaccine. But early successes do not guarantee a treatment will work.
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