What are the Different Phases of Clinical Trials?

Phases of a clinical trial in San Diego.

Over the last couple of decades, treatment for a litany of diseases and ailments have taken gigantic steps. Some conditions that were previously deemed untreatable have seen treatment breakthroughs in recent years, and much of that progress can be traced to clinical trials.

What are Clinical Trials?

Clinical trials are studies that test the safety and effectiveness of new drugs, devices, and other treatments on willing trial participants in a controlled setting. Trials allow scientists, medical professionals, and pharmaceutical companies to observe the effects of the treatment in a variety of individuals, with the hope of sending the results to the FDA for treatment approval.

Human Clinical Trial Phases

There are a variety of different types of clinical trials, and they are usually classified into one of four phases, numbered I through IV.

Phase I Clinical Trial

Phase I is the initial phase of testing, and mostly consists of evaluating the safety of a treatment, drug, or device. This phase will consist of a small number of volunteers, usually somewhere between 20 and 100 people, and will take several months to complete. These trials will test a treatment on humans to see the effects of the drug or device, observing if it is an effective treatment and if there are any negative side effects if the dosage is increased. Participants will be compensated for their participation, and approximately 70% of treatments pass this phase of testing.

Phase II Clinical Trial

While Phase I aims to measure the safety of the treatment, phase II seeks to measure the effectiveness of the treatment. This stage of a trial can last anywhere from a few months to two years, with several hundred individuals participating in the study. The trial usually consists of one “control” group that is given no treatment or a placebo, and a second group that receives the treatment in question. In an effort to keep bias out of the research results, the researchers are usually unaware of which group is receiving treatment. This is called a “blinded” study. About one out of three of treatments pass this phase of testing.

Phase III Clinical Trial

Phase III increases the scale of the trial, bringing in hundreds and even thousands of participants for a series of random and blind testing of a treatment. Over several years, phase III trials aim to prove to the pharmaceutical company and the FDA that the treatment is effective, the full range of side effects, and the benefits of the drug. 70% to 90% of treatments, drugs, and devices pass this phase of testing, and after completion of phase III, the results can be submitted to the FDA for approval to begin marketing the treatment.

Phase IV Clinical Trial

Phase IV clinical trials are usually implemented after the treatment has been approved by the FDA for sale to consumers. Also called Post Marketing Surveillance Trials, phase IV trials aim to compare their treatment to other treatments on the market, determine if the treatment is a cost-effective option moving forward, and monitor the long-term ramifications of the treatment on individuals. During this phase, if issues are discovered the drug can get hit with heavy restrictions or get taken off the market entirely.

Alcohol Abuse Treatment Clinical Trials in San Diego

The Pearson Center for Alcoholism and Addiction Research is currently running clinical trials to measure the effectiveness of new treatments for alcohol abuse and alcohol addiction. If you are struggling with alcohol and would like to get access to cutting-edge alcohol addiction treatment, sign up for a clinical trial today. To learn more about our clinical trials, contact us today by calling (858) 784-7867.