Phases of Clinical Trials and What They Mean

The term “clinical trial” can have varying meanings depending on the type of treatment being tested. Trials can be used for prevention, development of new treatments, diagnosing conditions, and testing genetics, to name a few purposes. In most cases, clinical trials begin with pre-clinical research on non-human subjects, such as on animals or in a lab. If this research shows that the treatment is effective, trials begin with human volunteers.

Phase I

In this phase, a small dose is administered to a small group of individuals, usually between 10 and 15. The aim is to learn the effects of the treatment and how it is processed in the human body. This allows researchers to identify a safe dosage for humans that still provides benefits.

Phase II

The clinical trials in this phase continue with the research and knowledge gathering of Phase I with a larger sample of people, less than 100. The doctors at Altus Research start by administering the dosage determined to be safe and effective in Phase I to more individuals to further identify side effects and safety of the treatment.

Phase III

In this phase, we greatly expand the testing of treatment, enlisting thousands of volunteers with the condition being treated to confirm the treatment’s effectiveness and side effects. At this stage, the treatment is also compared to existing treatments for the same condition, establishing whether this plan or others are better suited in terms of efficacy and risks.

Phase IV

The final phase of testing is done after government approval (usually from the food and drug association, or FDA). Phase IV trials are ongoing, further clarifying dosage instructions to reduce the risks of side effects, determining best-use scenarios, and exploring additional options and uses for the treatment.

Learn More and Join a Clinical Trial

Clinical trials are fully dependent on finding willing, eligible volunteers with whom testing can be done for new and vital treatments. Volunteers come from all walks of life, have a wide variety of pre-existing conditions that can benefit from a newly developed drug or test, and may be rewarded for their participation in a study. To learn if you may be eligible for helping bring a novel, potentially revolutionary treatment into the world, check out our currently enrolling studies or sign up for Altus Research’s volunteer database. Our physicians will let you know when your experience and individual condition may be needed for a clinical trial.

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