Coping with a chronic illness can be a difficult time for all participants. Depending on the situation, patients may feel limited due to the lack of viable treatment options. One of the frequently used alternative therapies is the use of experimental drugs. These medications belong to the category of medications that have not yet been approved by the Federal Drug Administration (FDA) for release by the consumer.
The FDA approval process for prescription drugs can last 10 to 15 years, depending on the medication. This may be an important waiting period for patients experiencing disabilities in the treatment of their disease. By participating in clinical trials of experimental medicine like GFT505 powder, the patient has the opportunity to try new treatments that are generally not offered. Although the nature of clinical trials carries significant risks, some patients are willing to take advantage of this opportunity in the hope of finding a cure. An important aspect in measuring this risk is the understanding of the stages of the tests.
The four stages of clinical drug trials are discussed below.
The purpose of the phase 1 test is to measure the overall safety and tolerability of a chemical compound. This is the first step in determining the suitability of a drug for use in humans. The study focuses on dosage thresholds and side effects, and usually lasts 6 to 12 months. Phase 1 trials are considered very unstable and risky. Because of this, they are usually carried out in healthy adults.
The Phase 2 test directive is to determine if a medication has the desired effect in a particular condition. These tests are usually blind experiments in which several medications are randomly assigned to placebo and among subjects. Neither the subjects nor the administrators know what method of treatment the subject receives. This allows researchers to measure the effects of multiple treatments with each other. Phase 2 trials can last up to 2 years and are performed with subjects suffering from a specific disease.
Tests Phase 3 tests are similar to those in Phase 2 because they are used to measure the effectiveness of an experimental drug in a specific state. The difference between the two phases is that phase 3 is carried out with a much larger sample size, and the trial period can last more than 3 years. This longer trial period allows the study of long-term side effects and provides a better analysis of appropriate dose ranges.
Tests The final phase of the clinical trial is used to further test the drug. Although the experimental drug is not yet approved in the early stages of phase 4 tests, it is generally considered safe for its intended use. Even after the drug has been approved by the FDA, this phase continues according to the requirements of the FDA. Long-term tests continue to assess the safety and efficacy of the medication, and alternative uses of the medication are being explored.