This blog post serves two purposes…it is my daily COVID update and inform you about clinical trials, what they involve (since it is in the news
Phase 0 trials are the first clinical trials done among people. They aim to learn how a drug is processed in the body and how it affects the body. In these trials, a very small dose of a drug is given to about 10 to 15 people
Phase I trials aim to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 15 to 30 patients. Doctors start by giving very low doses of the drug to a few patients. Higher doses are given to other patients until side effects become too severe or the desired effect is seen. The drug may help patients, but Phase I trials are to test a drug’s safety. If a drug is found to be safe enough, it can be tested in a phase II clinical trial.
Phase II trials further assess safety as well as if a drug works. Phase II trials are done in larger groups of patients compared to Phase I trials. Sometimes new combinations of drugs are tested. Patients are closely watched to see if the drug works. If a drug is found to work, it can be tested in a phase III clinical trial.
Phase III trials compare a new drug to the standard-of-care drug, if one exists. If not, patients get a placebo—a drug that does nothing. These trials assess the side effects of the tested drug or vaccine. Phase III trials enroll a large # of patients. Often, these trials are randomized. This means that patients are put into a treatment group, called trial arms, by chance. Randomization is needed to make sure that the people in all trial arms are alike. This lets scientists know that the results of the clinical trial are due to the treatment and not differences between the groups. A computer program is often used to randomly assign people to the trial arms. As a patient, neither you nor your doctor can choose your group. You will also not know which group you’re in until the trial is over.
Every patient in a phase III study is watched closely. The study will be stopped early if the side effects of the new drug are severe (e.g. the Astra-Zeneca vaccine trial) or if one group has much better results. Phase III clinical trials are often needed before the FDA will approve the use of a new drug for the general public.