What is Clinical Trial?
Clinical trials are a safe and FDA-regulated way to collect data and assess the safety and efficacy of a particular treatment. They are done under strict and regulated guidelines to assure patient safety and well-being. Once preclinical studies have been completed and proven safe, human trials begin in a stepwise 4-phase approach.
Healthy volunteers participate in Phase I studies to assess further the safety of the investigational treatment. Once the product is deemed safe, Phase II and III studies will evaluate the efficacy of the medication on a larger scale. Patients who suffer from a particular ailment can now volunteer to participate in a randomized control study that will determine the best and most efficacious method to utilize the treatment.
Phase IV study is conducted after the FDA has approved the treatment for commercial use. The trial is now considered a post-marketing analysis of the product to obtain additional information for commercialization. All phases of the clinical trials are conducted under Physician supervision, professional research staff, and under very strict FDA guidelines. ILD Research Center conducts only Phase II–IV trials.