On the edge of
microbiome exploration.

Participating in a clinical trial can give patients a precious gift: another option. When they have exhausted standard therapies and treatments, a clinical trial can give them access to the newest drugs and procedures in their final stages of approval, but not yet publicly available. By enrolling in clinical trials, patients also help to progress medicine, providing critical data on the effectiveness of new treatments and therapies, and potentially benefitting the patients who come after them.

Clinical trials are completed in a series of steps known as “phases,” each of which plays an important role in the investigation process and answers separate questions. Phase I clinical trials are usually completed with a small group of patients (20-80) to determine the safety of the drug or treatment and any side effects. Phase II trials involve a larger group of patients (100-300) to investigate the drug or treatment efficacy, continue safety monitoring, and determine other important details like dosage specifics. The last phase, Phase III usually involves the largest number of study participants (1,000-3,000). Phase III trials confirm drug or treatment efficacy and can be used to compare the study drug to other treatment options already available on the market. Following a successful Phase III trial, the investigator can submit a New Drug Application (NDA) to regulatory agencies like the FDA for approval to market the drug or treatment. Phase IV trials are completed following agency approval, also known as post-marketing surveillance to track drug or treatment effectiveness and real-world usage. All four phases ensure the safety, effectiveness, and real-world understanding of new drug and treatment options before and after they become available to the public.