FAQs

No. Membership allows investigators to schedule the use of subject rooms, group meeting room, conference room, and phlebotomy service at no charge. Use of the equipment in the CTSC Core Laboratory is also free-of-charge. Supplies needed for individual research projects must be provided by members' at their own expense.

The facilities within the CTSC are available for 24/7. During regular business hours (M-F, 9:00 AM-5:00 PM) the facility is open and staffed by its Director, a receptionist, and phlebotomist. At all other times, entry is limited to members and their authorized staff via ID swipe cards. All members and their staff will have their ID cards programmed for such entry.

The CTSC is licensed to use a HIPPA-compliant scheduling program called AppointmentPlus to ensure confidentiality of research subjects. All members will be given password access to AppointmentPlus which enables members (or their staff members) to request the use of subject rooms, etc. We require that reservations be made in advance. Detailed instructions will be provided when membership is initially granted.

No. Members and their staff who need to use equipment in the Core Lab will be trained by CTSC staff to use equipment.

No. All biospecimens used in the Core Lab must be used for research purposes only. While the equipment is calibrated (Downstate certification), it is not CLIA-certified.

Mice share more than 95% of our DNA – and this means that we're both affected by disease in surprisingly similar ways. By studying mice that have symptoms of diseases like Alzheimer's, diabetes, or cancer, we can learn a lot more about how these diseases might be treated in patients. The quest for the best mouse model – or best "representation" – of a disease is always ongoing. The closer we are to accurately modeling genetic diseases in the mouse, the closer we are to discovering cures in the clinic.

Clinical and translational science is the term for multidisciplinary, team-based research whose objectives focus on transforming basic science discoveries to improve human health through new diagnostic techniques, new therapies, advances in clinical practice and new community-based interventions or population health initiatives. It is often defined as a "bench to bedside" initiative involving research initiated in the lab with a new discovery in basic biological science which is then "translated" through clinical trials to help solve a problem in human health.

 A clinical trial is a clinical research study. This term most often refers to studies examining the effects of new medicines or medical devices but can also be used for any study aimed at improving medical treatments. Clinical research carried out in these trials try to determine whether new medicines, procedures, equipment or therapies are safe or will help in treating, diagnosing, preventing or caring for people with specific illnesses or conditions.

Clinical trials and research studies are important because they help us develop new ideas or approaches for treatment and prevention of diseases. They also help us determine which treatments are the most appropriate and cost-effective.

Participation in clinical trials allows individuals who are eligible to be subjects in specific studies to help advance science and knowledge about a particular condition. Such participation may also improve participants' own health.

The best way to find out about open clinical trials in the U.S. is to search the national clinical trials database (for instance for a specific disease of interest). You should find the appropriate contact info there, including clinical trials at SUNY Downstate Medical Center.

Clinical trials are divided into four phases because each phase has a specific purpose in helping scientists answer different questions about the drug or therapy being tested.

Phase I

• New treatment given to a small group (20-100 participants)
• Determine the safety of the drug therapy by:
  • How much is given (dosage)
  • What side effects occurred, if any
• Volunteers in Phase I trials are generally healthy volunteers

Phase II

• Medium size group (100-300 participants)
• Determine if the treatment has an effect on a particular condition
• Volunteers in a Phase II trial are typically those who have the condition of If the treatment was determined to be effective in Phase II then it will move into Phase III

Phase III

• Larger group (1000-10,000 participants)
• Compare the new treatment with a placebo or with standard treatment(s) to determine whether one is more effective
• Phase III trials can last many years and involve thousands of volunteers
• Once Phase III has been completed, the drug or device company will go to the FDA to request approval to sell the drug or device in the U.S. as a treatment for a particular condition.

Phase IV

• In Phase IV, the treatment has already been approved by the FDA and is ready for post-marketing
• Allows researchers to look at the treatment after it has been given to the general population to assess any side effects and safety issues that may not have been recognized in a Phase III trial
• Continue to monitor the effects of the drug in a larger population than possible in a Phase III trial
• Test to see if the drug may be useful to treat other conditions.

The Institutional Review Board (IRB) at SUNY Downstate must approve each clinical research study conducted by authorized faculty. The IRB's primary concern is the safety of patient participants. It monitors research protocols to ensure patient confidentiality and assesses risk associated with each clinical study.

REDCap (Research Electronic Data Capture) is a secure, Web-based tool for designing surveys and capturing data. For information or to access the software, contact Dr. Nira Goldstein at nira.goldstein@downstate.edu