Published: Apr. 1, 2008
Updated: Apr. 1, 2008
Clinical trials are designed to advance scientific knowledge while protecting trial subjects. Duke’s researchers must follow specific guidelines to ensure patients’ safety and privacy.
Before a new treatment is tested in patients, investigators conduct studies in research labs, often performing experiments in animal and human cells. This is usually followed by thorough testing in animals. If this research is successful, the FDA can approve the treatment for testing in humans.
Researchers must also design a protocol. This is a study plan that maps out the criteria for participation, schedule of procedures and treatments, and length of the study.
Duke has an independent Institutional Review Board (IRB) that reviews and approves the protocol, consent form, and all other documents for each study. In addition, the IRB reviews each study at least yearly as long as the study is active. To get approval, the study must protect the rights of study participants and ensure that the study does not present undue risks to the participants
Most clinical research that involves the testing of a new treatment progresses in phases. This allows researchers to ask and answer questions in a way that yields reliable information about the treatment and protects the patients.
Clinical trials are usually classified into one of three phases:
Click a link to find out more about clinical trials at Duke.