Clinical trials are a crucial type of clinical research where various behavioral, surgical, and medical interventions are tested on willing participants. They are used to evaluate the safety and effectiveness of a new treatment before it is introduced to the public. Additionally, clinical research Falls Church trials are responsible for identifying new ways to diagnose diseases and improve the lives of people with chronic illnesses. These are usually done in stages called phases. If you are planning to sign up for a clinical trial, here is a look at the five phases you may go through during the process.
Phase 0 Trials
Not all clinical trials include a Phase O. For those that do, this stage, which is the earliest of any drug trial, is designed to determine whether a drug behaves as lab studies suggest. Phase O often involves a small number of participants who receive a very small dose of the drug being tested. In cancer studies, participants may be required to provide cancer tissue, blood samples, and scans to help researchers examine how the drug behaves in their bodies.
Phase 1 Trial
Most clinical trials begin with the Phase 1 stage. Like Phase O, this part of the clinical trial involves a few participants. The goal is to determine a safe dose, the possible side effects, and the effect of the drug on the body. Phase 1 trials also check how effectively a drug is combating a disease. Patients are often recruited at a staggered pace onto this stage, so while it might involve a few people, Phase 1 can take a long time to complete. Moreover, the doses are often escalated so that the first patients receive a small dose, and the next few patients receive slightly more if all goes well.
Phase 2 Trials
When a treatment makes it to Phase 2, it undergoes testing to determine if it works well enough to be tried on a larger sample of participants. This phase also involves determining the strain of disease the treatment works for, such as the type of cancer and how to manage the side effects. Typically, Phase 2 is larger than Phase 1 and can involve up to 100 participants.
Phase 3 Trials
Phase 3 trials focus on comparing the treatment with other available treatments. During this phase, the researchers determine whether the treatment works better than the standard treatment while studying its impact on the quality of life of the patent. They often also compare the treatment by varying the doses, finding a new way to administer a standard treatment, varying the frequency, and more.
Phase 4 Trials
By Phase 4, the treatment has been proven effective and received FDA licensing. This stage takes place after FDA approval and is designed to determine the rarer side effects of the treatment, its safety, and long-term benefits and risks.
Sign Up for a Clinical Trial
Clinical research helps medical experts find new and better ways to treat diseases. As a participant, signing up for a clinical trial can help researchers gather the data they need to improve and introduce a safe and effective treatment to the public. You can participate in these trials by signing up at a clinical research center. The experts there will walk you through the recruitment process and explain the different phases of the trial in greater detail.
Clinical trials are only one step in the discovery and creation of drugs. Check out the infographic below to see the full story of the drug discovery process
Infographic provided by OmniAb, an antibody discovery platform research organization