At Banner Research, our skilled and experienced researchers take careful consideration when designing clinical trials. To ensure participants’ safety while gathering ample information about the treatment being tested, clinical trials are conducted in four phases. Each phase has a unique purpose, answers specific questions and builds on information from a previous phase(s). In most cases, clinical trial participants are only involved in one phase of the clinical trial.
Phase 1 trials are intended to confirm the safety of a new treatment, any possible side effects, a safe dosage and the best way to administer the treatment, such as orally or intravenously. Phase 1 typically lasts several months and includes 20 to 100 participants. Participants are divided into small groups, called cohorts.
Phase 2 trials usually include up to several hundred participants and can last anywhere from several months to two years. This phase helps researchers confirm how effective the treatment is for a particular illness.
Phase 3 trials begin once the treatment has demonstrated that it is safe and effective for treating a specific illness. Phase 3 is intended to compare the new treatment to the standard treatment. This is done by “randomization”, a process that automatically assigns participants to either the study group that receives the treatment being tested, or the control group that receives a placebo with the standard treatment. While participants have a chance of being placed in either group, they usually don’t know which group they are placed in.
This phase also evaluates the effects of various dosages and combinations of treatments on different populations such as men, women and people of different ages and ethnic groups. This phase includes 300 to 3,000 participants and can last between one to four years.
There may be enough data collected from phase 3 to submit the treatment to the Food and Drug Administration (FDA) to be approved for clinical use.
Phase 4 clinical trials begin once the treatment is approved by the FDA and is available for doctors to prescribe to the general population. This phase is intended to determine how the treatment works long-term, including side effects that appear after extended use. If patients exhibit harmful side effects or other health concerns from the treatment, restrictions may be placed on the treatment or it may be taken off the market.
Banner Research invites healthy people and people with a disease or illness to participate in our trials. By volunteering, you are making a difference in advancing medicine and helping future generations. Learn how you can support research or join a clinical trial today.