A clinical trial is a research study designed to evaluate potential new treatment options. These studies are the result of a long and deliberate research process that often takes years. Clinical trials test the safety and effectiveness of new or modiﬁed drugs, new drug doses, unique approaches to surgery or therapy, and varied combinations of treatments. Clinical trials are an integral component for improving the treatment of medical conditions because they lead to higher standards of care. In the United States all new treatment products must proceed through a clinical trials evaluation process to ensure that they have an acceptable level of safety and demonstrate beneﬁt to helping patients with a speciﬁc disease before they become commercially available to other patients.
Clinical trials essentially fall into two general categories:
- The ﬁrst general category of clinical trials is designed to evaluate new drugs, compounds, or biologic agents that have not yet been approved by the Food and Drug Administration (FDA) for administration to patients. All substances must go through several phases of clinical trials to document their safety and effectiveness before the FDA approves them for routine use to treat patients. Prior to FDA approval, these substances are only available through clinical trials; however, after FDA approval, they are commercially available.
- Clinical trials may also evaluate drugs, compounds, or biologic agents already approved by the FDA for the treatment of one type of disease. These substances have already been determined to be safe by the FDA and they are now being evaluated in different doses, schedules, and combinations to determine how to optimally use them for the treatment of a variety of diseases.
Upcoming trials in
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MONGERSEN (GED-0301) FOR THE TREATMENT OF SUBJECTS WITH ACTIVE CROHN’S DISEASE
M14-234 study, “A Phase IIb/III, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis ”
M14-533 study, “A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC).