Clinical trials are conducted under an international agreement of oversight by the US FDA, Canadian FDA and regulatory authorities in Europe and Japan. The agreement focuses on GCP (good clinical practices) which clarify that patient safety takes precedence over testing any new drug or device. These agencies oversee the studies internationally. They approve of the protocol and follow the study from conception to completion.  IRBs (Institutional Review Boards), known as Ethics Boards outside of the US, also approve the design of the study and monitor the studies to confirm safety and other ethical approaches are maintained. The inclusion/exclusion criteria for clinical trials are designed so that those who participate are those in whom participation is appropriately safe and ethical while excluding people for whom participation may not fully meet these criteria. Patients are seen typically more frequently in clinical trials than in clinical practice. At these visits not only is response to treatment assessed, but also ongoing patient safety procedures are performed which may include physical exams, blood tests, and imaging tests.

Participants may have a desire to help develop new and better treatments or want medical attention for a condition that has resisted treatment. Some are unable to afford effective commercially available treatments.

www.clinicaltrials.gov

This website has been established by the FDA through a mandate from the US Congress to provide information concerning clinical trials in general as well as the specifics of all clinical trials being conducted in the US.

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