FDA Guidance
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Office of Clinical Trials (OCT)

What is a Clinical Trial?

Clinical trials involve participants who may receive experimental medical interventions in the form of medical procedures, drugs, or devices. The investigator observes the effects of the experimental intervention in a controlled environment. Participants of clinical trial studies are assigned or randomized into different treatment groups in an attempt to control for investigator bias. Clinical trials may compare a new medical approach to an available standard of care or to a placebo containing no active ingredients, or to no intervention at all. Additionally, some trials compare available interventions to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or better than an existing and available treatment alternatives (including no intervention). Clinical trial investigators try to determine the safety and efficacy of the intervention by measuring specific outcomes in the participants.

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Upcoming Events

Lunch & Learn: Postponed Until Further Notice   





The Montefiore Einstein Office of Clinical Trials 

Montefiore Medical Center
111 East 210th Street
Moses Research Tower, 8th Floor, Room 8-014

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