SUNY Downstate Health Sciences University
Office of Research Administration
What is a clinical trial?
A clinical trial is a prospective, biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, vaccines, biologics, treatments, medical devices, or new ways of using known drugs, vaccines, biologics, treatments or medical devices). Behavioral interventions are intended to prevent or treat an acute or chronic disease or condition.
Checklist for Applicable Clinical Trial
Effective April 18, 2017, the FDA and NIH have expanded their regulations and policies for the governance of Clinical Trials.
Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious and effective. There are four phases of clinical trials and each phase is designed to answer a specific and separate research question.
- Phase I
- To test a new drug or treatment in a small group (20-80) of people for the first time to evaluate its safety; determine a safe dosage range; and identify side effects.
- Phase II
- To test the drug or treatment in a larger group (100-300) of people to see if it is effective and to further evaluate its safety.
- Phase III
- The drug or treatment is given to large groups (1,000-3,000) of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely.
- Phase IV
- These studies are done after the drug or treatment has been marketed to gather information on the effect in various populations and determine what, if any, side effects are associated with long-term use.
There are several central offices on campus that will assist you in preparing and running a clinical trial:
- Office of Research Administration
- Sponsored Programs Administration
- Finance and Administration
- Institutional Review Board
- Office of Technology Commercialization
- Research Pharmacy
Sponsored Programs Administration will assist with the review, negotiation and execution of confidential disclosure agreements (CDAs) and non-disclosure agreements (NDAs). They are responsible for the review and negotiation of all clinical trial agreements (CTAs) and provide assistance and consultation with budget preparation. SPA interacts and communicates with sponsors, clinical research organizations (CROs) and other entities on behalf of the institution, researchers and departments on issues related to clinical trials.
Finance and Administration will establish a business process for invoicing and the collection of revenues based on the executed clinical research agreement. Any invoices that do not require case report forms (CRFs) will be prepared and processed by grant managers. They will work with the study coordinator to record and follow up on the receivable generated by CRFs that are required to secure payment.
The Research Pharmacy will store and provide drug preparation for your clinical trials and follow all sponsor and federal requirements in regards to dispensing and destroying medications.
The Institutional Review Board is responsible for reviewing and approving all IRB protocol submissions.
The Office of Technology Transfer provides assistance as it relates to inventions, intellectual property rights and ownership.
Please don't hesitate to contact any of the offices noted above if you have any inquiries regarding their roles in clinical trials at Downstate and any assistance they can provide in getting your clinical trial up and running.