Clinical Research Studies With Dr Scott Levenson and Dr Roger Kao
A clinical research trial is used in medicine to evaluate new drugs, medical devices, biologics, or other interventions on patients in strictly scientifically controlled settings, and are required for regulatory authority approval of new therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. The trial objectives and design are usually documented in a clinical trial protocol. A placebo, an inert compound, identical in appearance to a medication being studied, is sometimes used in clinical research trials.
Good clinical practice guidelines are standards provided by International Conference on Harmonisation (ICH) – an international body that regulates clinical trials involving human subjects. These guidelines include protection of human rights as a subject in clinical trial, how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and Clinical research associates.
An institutional review board/independent ethics committee (IRB/IEC) (also known as ethical review board) is a group that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. In the United States, IRBs are mandated by the Research Act of 1974, which defines IRBs and requires them for all research that receives funding, directly or indirectly, from the Department of Health and Human Services (HHS). In accordance with Food and Drug Administration (FDA) and HHS regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.
The following clinical research trials are ongoing at Dr. Levenson’s and Dr. Kao’s office:
Crohns Disease – A 60 week clinical study testing a novel approach for the treatment of Crohn’s disease: treating the bacteria which may be a cause of Crohn’s disease.
The study medication is in pill form and is a combination of three antibiotics: clarithromycin, rifabutin, and clofazimine. Remission at week 26 is the primary objective of the study. Please visit www.MAPmyCrohns.comfor more information.
If you are interested in any of the above mentioned studies or for more information, please call (650) 596-8800, extension 19.
Please continue to check this website for additional study details as they begin! Thank you.