OFFICE OF SCIENTIFIC AFFAIRS AND BIOTECHNOLOGY
CLINICAL RESEARCH AT DOWNSTATE MEDICAL CENTER
Clinical Research Support
The faculty at Downstate Medical Center bring to the Center's community the most advanced clinical interventions available. Through the oversight of the Center's Clinical Research Office and the Institutional Review Board, these clinical trials are undertaken with the protection of the subjects' rights and health being of primary concern.
What are Clinical Trials?
- Types of clinical trials:
- Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
- Screening trials test the best way to detect certain diseases or health conditions.
- Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
- Phases of clinical trials:
- Phase I Trials: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
- Phase II Trials: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
- Phase III Trials: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.
- Phase IV Trials: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.
Clinical Trials at Downstate Medical Center
Link to the clinical trials currently active at Downstate, many of which are still in the subject recruitment phase. Individuals or physicians interested in these trials should contact the investigator responsible for the study:
ClinicalTrials.Gov is a registry of active federally and privately supported clinical research in human volunteers. The database provides information about a trial's purpose, who may participate, locations and phone numbers for more study details. Downstate Medical Center investigators should register their active studies (Downstate is already a "registered organization" for ClinicalTrials.Gov):