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What are Phases of Clinical Trials?
The development of new treatments usually progresses through levels of research, called phases, in the process of testing new drugs and procedures before they can be approved and released for general use.
Who Conducts the Clinical Trial?
Every clinical trial is led by a “principal investigator,” often a medical doctor or other medical professional. The principal investigator leads the research team that might include doctors, nurses and other health care professionals. The principal investigator is responsible for making sure the study is carried out properly and safely.
How Are Clinical Trial Participants Protected?
Before joining a study, participants undergo a process of Informed Consent, which includes discussion of the risks and potential benefits of participating in a study.
The institution conducting the research must utilize an Institutional Review Board (IRB). The IRB is made up of physicians, researchers, and community members. The board reviews every study before deciding if the study can move forward. The main focus of the IRB is to protect the rights and welfare of study participants. The IRB monitors each study, at least annually, throughout the life of the study.
The Food and Drug Administration (FDA) has strict regulations for the conduct of clinical trials to ensure the protection of study participants.
For additional inquires, contact JCTOSRC@med.cornell.edu
Who Can Participate in a Clinical Trial?
Many studies are designed for people with specific diseases or conditions. Others are looking for healthy volunteers, and some studies enroll both individuals with diseases/conditions, as well as, healthy volunteers for comparison. Every clinical trial has detailed criteria that determine whether an individual is eligible to participate.