Clinical trials have multiple phases that test for safety, efficacy and efficiency of a drug before it can be prescribed by doctors. The majority of Meridien Research studies are in phase III or IV. But what does that mean? Read on to learn more about what happens in each step of the clinical trial process.
Phase I: This is the very beginning of a long road medical treatments take before they hit the market. The main goal of this phase is to determine the proper and safe dosing range for the medication, as well as side effects. Only a few people, 20-100 or so, participate in this phase of a clinical study. Generally, healthy people make up the trial participants in this phase, but sometimes seriously ill individuals who have not responded to traditional forms of treatment will also be selected. In addition to safety and dosing, the processing and absorption of the drug in the body is also studied.
Phase II: In phase II, clinical researchers continue studying the safety and proper dosing of the drug, but they also examine the drug’s efficacy – how well does the drug do what it is supposed to do at safe doses? Treatments that are found to have no biological effect are abandoned if they fail this stage. About 100-300 people participate in a phase II study.
Phase III: The majority of Meridien Research studies are phase III or IV studies. In this stage, researchers are looking to see how effective a treatment is. While efficacy is about how the drug influences the disease, efficiency is about how the drug influences the patient. An effective drug should help a patient feel better, make them need to go the hospital less or extend their life. In phase III, patients with the condition being studied make up the population. This is the largest group of participants of any phase, with about 1,000 to 3,000 people in the trial. At this point, treatments have passed rigorous FDA standards and have been determine safe to use at the doses given. Participants in phase III and beyond are in no serious danger from the treatments given.
Phase IV: Also known as “post-marketing surveillance,” this phase is actually just an observation of the effects the drugs have on patients once the drug has been put on the market. Now, rare and long-term adverse effects that would not have been seen in phases I-III can be discovered in a much larger population. Also, the drug’s effects in specific populations, like pregnant women, are studied.
If you would like to learn more about the clinical trials currently running at Meridien Research, call 888-777-8839 or click here.