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 done 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.
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.
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.
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.
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.
Need a Clinical Research Administrator (CRA) or Clinical Research Coordinator (CRC)?
If you are doing a clinical trial and need a CRA or CRC, we can on-board one for you. The associated salary charges will be applied to your award.
Who do I contact?
There are several central offices on campus that will assist you in preparing and running a clinical trial:
The Contracts team will review, negotiate and execute Confidential Disclosure Agreements (CDAs) and Non-disclosure Agreements (NDAs). They are also responsible for the review and negotiation of all Clinical Trial Agreements (CTAs). They interact and communicate with sponsors, clinical research organizations (CROs) and other entities on behalf of the institution, researchers and departments on issues related to all clinical trials.
The Regulatory Coordinator arranges for the cost analysis, budget preparation and negotiation with sponsors on all clinical trial pharmaceutical budgets, in addition to the supervision and engagement of study coordinators and clinical research administrators working on various clinical trials.
Finance and Administration will ensure, upon closeout, that all revenue has been received based on the eCRFs submitted, in collaboration with WCG and the study team.
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.
Clinical Trial Price List
Prices vary depending on the complexity of the study. Start-up costs are identified below:
IRB: $3,000 for initial protocol review; $1000 for continuing review; $500 for substantive amendment
Pharmacy: $1,500 startup plus additional fees for dispensing, storage, etc. Price list must be obtained from research pharmacy prior to budget negotiation with sponsor.
$2000 - cost analysis, budget preparation, negotiation and revenue collection
$2000 - contract review and negotiation
$1000 - CRA protocol preparation with IRB
$125.00/hour for monitoring (up-front costs)
Close-out costs include:
Pharmacy - $500
CTO Division - $1000 CRA closeout
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.