Clinical trials are conducted in phases that build upon one another which are designed to answer certain questions. Clinical trial volunteers can expect different benefits and risk for each phase. It is good to know which phase of the trial you will be participating in so that you can manage your expectations going in. The Investigative Clinical Research Group performs research regarding gastrointestinal health concerns that affect more than 100 million people worldwide. With trials in all different phases, the hope is to determine if a new treatment will be effective.
The first phase of any clinical trial is Phase 0. Phase 0 explores if and how a new drug or treatment may work. Phase 0 studies are different than other phases of the trial process. This phase is designed to streamline and speed up the approval process of a drug or treatment. With the hope of saving time and money in the later phases, Phase 0 is used to determine if the drug does what it is expected to.
Phase 0 studies use only a small amount of the drug in a small number of volunteers. This is used to see how the drug acts in the human body and if it attaches itself where it is expected to. Unlike other phases, the people who participate in Phase 0 will not receive any benefits from the treatment, the benefit will go towards other patients in the future. Phase 0 volunteers are very unlikely to experience any negative side effects for this reason.
Phase I clinical trials are set up to see if the treatment is safe. They are done to find the highest treatment dose that can be administered without causing severe side effects. Although at this point, the treatment has been tested in animal and lab studies, there is no evidence regarding how the human body will respond to the treatment.
Phase II clinical trials ask if the treatment works. Phase I tests to see if it is safe, Phase II is done to see if it works in certain forms of gastrointestinal disease. The benefits are based on the end goal of the treatment. Does it relieve or remove gastrointestinal symptoms, does it keep symptoms the same or make it worse, or does it increase the time between flare-ups? Sometimes the benefit can simply be an improved quality of life.
Phase III asks if the treatment is better than what is already available. If a treatment has yielded positive results in Phase II, Phase III will compare the effectiveness and safety of the new treatment against the current standard. Volunteers will be chosen at random with some given the new treatment, while others will receive the current treatment. At this point, neither the patient nor the doctors and scientists will know which treatment has been given. The results will then be measured against one another.
Phase IV asks what else do we need to know? After Phase III the treatment will go to the FDA for approval. Treatments that are approved by the FDA are then monitored for a period of time in Phase IV to measure long-term effects and any other benefits or risks that come with the new treatment.