Clinical Trials Glossary
The title of the clinical trial.
Principal Investigator (PI)
The Principal Investigator is the doctor responsible for conducting the clinical trial.
The Velos or NCT (National Clinical Trial) identifier number assigned to the trial.
A brief description of the clinical trial.
Clinical trials are conducted in phases that take the trial through each stage before the U.S. Food and Drug Administration (FDA) approves it. At least three phases are required before a new medication can be approved by the FDA.
- Phase I trials: These first studies in people evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
- Phase II trials: A phase II trial continues to test the safety of the drug, and begins to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
- Phase III trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide
- Phase IV trials: In addition, after a treatment has been approved and is being marketed, the drug's maker may study it further in a phase IV trial. The purpose of phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in phase III clinical trials. Thousands of people are involved in a phase IV trial.
The coordinator you can contact if you're interested in taking part in the clinical trial.
Available at the following location(s)
The Dartmouth-Hitchcock location where the study is being conducted.
View more details from ClinicalTrials.gov
This link will take you to the complete trial description on the ClinicalTrials.gov website.