What are Clinical Trials?
Clinical Trials are studies conducted on human subjects for verifying the clinical, pharmacological and adverse effects of the drug. These are clearly defined and well designed studies to meet the objective of determining safety and efficacy of the new drug. They are generally comparative studies conducted in a randomized double blind fashion. The subjects participating in the study are duly informed about the risks and benefits involved in the study and a written voluntary consent is obtained. A protocol is prepared describing the details of the various steps and procedures to be followed which must be duly approved by an independent Ethics Committee. The data generated is submitted to the regulatory authority with New Drug Application for registration and marketing approval.
Clinical trials are studies of new kinds of cancer treatments. Doctors conduct clinical trials to learn how well new treatments work. They also study what the side effects are. If new treatments look promising, they are compared to the current treatment. The goal is to see which one works better or has fewer side effects. People who take part may benefit from access to new treatments before the FDA approves them. Participants also help further our understanding of cancer. That helps future cancer patients.
Clinical trials are studies of new kinds of cancer treatments. Doctors conduct clinical trials to learn about how well new treatments work and what their side effects are. If they look promising, they are then compared to the current treatment. The comparison shows if it works better or has fewer side effects. People who participate in these studies may benefit from new treatments before the FDA approves them. The FDA is the government agency in charge of new treatments for diseases. People who take part also help further our understanding of cancer and help future cancer patients. Reviewed By: Wesley J. Fowler, Jr., MD, Vice Chair and full Professor, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill Karl Podratz, MD, Professor, Department of Obstetrics and Gynecology, Mayo Medical School. Director, Gynecologic Oncology Fellowship Training Program, Mayo Clinic Jonathan S. Berek, MD, Professor, UCLA School of Medicine.
Clinical trials are studies of new kinds of cancer treatments. Doctors use clinical trials to learn how well new treatments work and what their side effects are. Promising treatments are ones that work better or have fewer side effects than the current treatments. People who participate in these studies get to use treatments before the U.S. Food and Drug Administration (FDA) approves them. People who join trials also help researchers learn more about cancer and help future cancer patients. Women’s Cancer Network (www.wcn.org).
Clinical trials are studies of new kinds of cancer treatments. Doctors use clinical trials to learn how well new treatments work and what their side effects are. Promising treatments are ones that work better or have fewer side effects than the current treatments. People who participate in these studies get to use treatments before the U.S. Food and Drug Administration (FDA) approves them for the public. People who join trials also help researchers learn more about cancer and help future cancer patients.
