What are Los Angeles Clinical Trial Phases?
The definition of a clinical trial given by the World Health Organization is, “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” Clinical studies are useful for ascertaining the potential value that a treatment has in terms of disease management. Due to the fact that subjects are voluntary, investigators commonly provide paid clinical trials as reimbursement for time and effort. Finding, evaluating, and gaining approval for useful treatment options is a tedious process, consisting of 4 important phases. Volunteers may be sought for different phases of clinical trials, which is why it is important to understand each phase before signing up.
Phase 1 Los Angeles clinical trials mark the very first time that a drug or other treatment is tested. The purpose of the first level of clinical trial phases is to assess the effect that the particular treatment has on various biological functions, including how the treatment is taken into, and excreted from, the human body. The subject group is small, comprised of 20 to 100 healthy people, notes Center Watch. Generally, volunteers are compensated, and phase 1 research usually includes paid clinical trials. Other phases may provide payment as well, depending on the study. Center Watch also states that approximately 70% of experimental drugs tested in phase 1 are approved for phase 2; approval is based on the safety profile of the tentative treatment.
Provided that phase 1 clinical trials are successful (meaning that the administered treatment is deemed safe enough to continue), researchers can begin the second part of the four clinical trial phases. During the second phase, researchers study the effectiveness of the treatment for people who have a specific disease. The number of test subjects ranges from 24 to 300, declares the U.S. Food and Drug Administration. Within this time, studies are usually randomized and double blind (neither the patient nor the experimenter knows who received the true treatment), with one group receiving the treatment and the other being administered a placebo (a sugar pill). Randomized, double blind studies are conducted because they allow researchers to present bias-free comparative data to pharmaceutical companies and the FDA. Studies may last for several months to two years, and about one third of treatments pass phase 2 trials, says Center Watch. Here, short-term side effects are evaluated, as well.
If a treatment passes the first two stages, the third segment can take place. The subject population size can range anywhere from a couple hundred participants to 3000, states the U.S. Food and Drug Administration, and can last for many years. During this time, long-term information and effects of the treatment can be measured. According to Center Watch, approximately 70-90% of treatments that make it to this step are approved. After this, researchers can request permission from the FDA to market the treatment.
Stage 4 is the last of the clinical trial phases, and is referred to as a Post-Marketing Surveillance Trial. This is necessary so that pharmaceutical companies can compare the newly accepted treatment with others on the market, monitor long-term impact and usefulness, and determine the cost-effectiveness compared to other treatment options, says Center Watch. Depending on the study’s results, a treatment may be taken off the market or have new regulations set in place for its use.
Los Angeles clinical trials are a necessary element of medical research that help to shed new light on applicable measures for controlling disease. In order to be approved for use by the FDA, treatment methods must go through a rigorous 4-step procedure, simply known as phases 1 through 4. Researchers often offer paid clinical trials in order to compensate volunteer subjects for their contribution to medical knowledge.
If you are interested in enrolling in Los Angeles clinical studies for depression, fibromyalgia, smoking cessation, or PTSD, contact the Pacific Institute of Medical Research, which is an independent clinical research site specializing in psychiatry since 1982. Visit us online or call us at (310) 208-7144.