Clinical trials are a way of collecting data to understand the safety and efficacy of new medical treatments. Clinical trials are an important step on the way to getting approval for a treatment, and there are typically four phases to any clinical trial, starting with Phase 1 clinical trials and ending, hopefully, with approval from the FDA. Each phase is considered a separate trial, and it is possible for a drug or treatment to fail at any point.
Are CNS Trails Really Necessary?
The pharmaceutical industry is responsible for curing many deadly diseases that plagued the world even just a few decades ago. Hepatitis C, for example, used to require lifelong treatment and often ended with the need for a liver transplant. Today, between 90% and 95% of people with hepatitis C can be cured with an 8 to 12-week drug treatment. The pharmaceutical industry currently spends almost $150 billion every year on research and development, and as of 2014, pharmaceutical companies made up five of the world’s top 11 research and development firms. Whenever you walk into a pharmacy and see one of the 100,000 over-the-counter products, not to mention prescriptions drugs, that are currently for sale, you can know that a very long and involved process was behind discovering, developing, and ensuring the safety of these useful drugs.
Phase 1 Clinical Trails
In Phase 1 clinical trials, safety is the primary concern. Researchers hope that the treatment they have developed will work as expected. They may have an idea of what side effects could surface, but there is no way to tell for sure until the treatment is tested. Phase 1 clinical trials typically involve between 20 and 100 healthy, paid volunteers. The Phase 1 clinical trials evaluate how the treatment works. This means understanding how it is absorbed, how the body metabolizes it, and how is excreted. Side effects are investigated, and dosage levels may be increased or decreased. Approximately 70% of all drugs will make it through Phase 1 clinical trials.
Phase 2 Clinical Trials
During the Phase 2 clinical trial, the side effects and efficacy of a treatment continue to be evaluated. Phase 2 trials often involve hundreds of patients and can last as long as two years. Most trials are randomized, which means that one group receives experimental treatments while a second group receives either the current standard treatment or a placebo. Whenever possible, blind studies are conducted. A blind study is one in which neither the patients nor the researchers know which group is receiving the new treatment and which is receiving the placebo. About one-third of treatments that make it through Phase 1 clinical trials and into Phase 2 trials will successfully go on to Phase 3 clinical trials.
Phase 3 Clinical Trials
During this phase of testing, all studies are randomized and blind and can involve hundreds and even thousands of patients. Testing can go on for years and is designed to provide researchers and the FDA with as thorough an understanding of the effectiveness of the treatment as possible. Phase 3 is also a chance to study any long-term side effects that may come up. Approximately 70% to 90% of treatments that enter a Phase 3 drug trial will make it beyond this phase. Once Phase 3 is complete, researchers can request that the FDA approve the drug or treatment.
What Happens Next?
Once a drug or a treatment is approved, it can be used by doctors and patients. However, at the same time as the treatment begins public use, it also undergoes Phase IV studies. During this phase, the drug is compared with other drugs on the market and its long-term effectiveness and impact are carefully considered. During this time, researchers look at the cost-effectiveness of the new therapy relative to existing therapies and treatments. It is possible for this phase to result in the medical treatment being removed from the market entirely or restricted in some way.
Clinical trials are a crucial part of the drug and treatment development process. Clinical trials make it possible for us to develop and use new and more effective treatments to improve everyone’s quality of life.