If Interested in Enrolling
Information about our clinical study can be found at ClinicalTrials.gov by using the identifier: NCT03058289.
FAQs - Clinical Studies
What are clinical studies?
Clinical studies are research studies in which real people participate as volunteers. Clinical research studies are a means of improving our understanding of disease, such as in observational studies, or developing new treatments and medications for diseases and conditions, such as clinical trials, which are evaluating the effects of a biomedical or behavioral intervention on health outcomes. There are strict rules for clinical trials, which are monitored by the National Institutes of Health for the trials it funds, and the U.S. Food and Drug Administration more broadly. Some of the research studies at the Clinical Center involve
Why should I participate?
The health of millions has been improved because of advances in science and technology, and the willingness of thousands of individuals like you to take part in clinical research. The role of volunteer subjects as partners in clinical research is crucial in the quest for knowledge that will improve the health of future generations. Without your help, the research studies at the Clinical Center cannot be accomplished.
What are Phase 1, Phase 2 and Phase 3 studies?
The phase 1 study is used to learn the “maximum tolerated dose” of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts. Phase 1 studies typically offer little or no benefit to the volunteer subjects.
Phase 2 clinical trials evaluate the efficacy of new drugs at various doses, the safety of said treatments and dosage specifications. Phase 3 clinical trials evaluate safety and efficacy in a larger set of patients. Results are often used for marketing approval. In cancer research, product approvals can occur with phase 1b or 2b studies of sufficient size that demonstrate safety and efficacy.