Are Clinical Trials
Clinical trials are crucial step in the process of bringing new and developing pharmaceutical therapies to patients. The process of developing new therapies takes many years and is strictly regulated by agencies such as the US food and drug administration (FDA) via a multiphase development process.
New and experimental therapies are first tested on animal subjects in a closed laboratory environment. If the results are shown to meet certain safety standards and prove scientifically viable as a new therapy, the therapy may then advance into clinical trials in humans.
Phase 1
Phase 1 trials are the first time a new therapy is tested in a human, and as such this phase is limited to a small number of participants. In this phase, doctors are more interested in how the therapy interacts with the patient as opposed to its effectiveness in treating specific symptoms or diseases. This phase allows researchers to determine interactions, how long the therapy is in the bloodstream, and any other potential side effects may occur.
Phase 2
Phase 2 trials usually serve to ascertain the viability of the therapy’s ability to treat specific medical conditions. Here, potential drug interactions dosage information is also collected to determine the best way to administer the new treatment. These methods may include tablets, infusions, injections, and even extended-release capsules. This phase commonly involves a larger number of participants who have a medical condition which the therapy is intended to treat.
Phase 3
Phase 3 is meant to test the results of the previous phases by introducing comparative methods. This phase involves much larger groups of people, sometimes into the thousands, across multiple geographic locations. These tests are often randomized where participants might receive the experimental therapy, placebo, or another therapy. It is from this phase that the primary basis for the benefit/risk assessment is analyzed for inclusion in final labeling if approved by regulatory agencies.
Registration
The next step is to file an application for registration with the food and drug administration (FDA). If approval is granted, the therapy can be sold as defined by the final approval label granted by the FDA.
Phase 4
Phase 4 trials are conducted after the therapy is released in the market. The purpose of this phase of trials is for the researchers to collect additional information about the long-term effects of the therapy, as well as optimal use. These trials may recur indefinitely.
All of our clinical trials are done under strict regulation and compliance, supervised by certified medical professionals and Principal Investigators whose sole purpose is to ensure the safety of their patients.
By partnering with Advanced Medical Trials, you are on the front lines of driving medical research forward, impacting the lives of future generations.