With the rather discouraging announcement by Johnson & Johnson and Eli Lilly that enrolment for its COVID19 antibody treatment has been paused due to one participant having developed an “adverse reaction,” many people have grown curious about the entire clinical trial process. Clinical trials have five phases. The phases are described below using the example of a new drug treatment
- Phase 0: In these trials, a very small dose of a drug is given to about 10 to 15 people. Phase 0 trials are the first clinical trials done among people. At this stage, subjects are given a dose too low to cause any therapeutic effect. They aim us to learn how a drug is processed in the body and how it affects the body.
- Phase I: The drug in question is tested in a slighter larger group of 15 to 30 patients. Low doses are given to begin with and these dosages increase slowly until side effects begin to be seen. If a drug is found to be safe enough, it can be tested in a phase II clinical trial.
- Phase II: The goal of phase II trials is to further assess safety of the drug as well as to determine if it actually works. Here, as in all stages, patients are closely monitored by doctors. If at this point the drug is found to work, it can then be tested in a phase III clinical trial.
- Phase III: Phase III assesses the side effects of each drug and which drug works better. With Phase III trials 100 or more patients are recruited to help in this goal. There can be more than two treatment groups in phase III trials. The trial will be stopped early if the side effects of the new drug are too severe or if one group of these groups shows much better test results.
- Phase IV: Finally, Phase IV trials test new drugs approved by the FDA. In this phase, doctors can also learn more about how well the drug works and if it’s helpful when used with other treatments.
Clinical trials are important for discovering new treatments for diseases. They also help to determine new ways to detect, diagnose, and reduce the chance of developing diseases. Moreover, clinical trials can show researchers what does and doesn’t work in humans vs. what works in the laboratory (in vitro) or in animals. Thus, clinical trial participation is beneficial for all of society. Let us find a trial that you can participate in for cash.