Center for Healthy Aging Clinical Trials Workshop

 

Join us for an engaging in-person workshop designed for fellows, junior faculty, and students eager to deepen their understanding of clinical trials. This interactive event will cover the core principles of clinical trial design, conduct, analysis, and ethics. Through expert-led sessions and real-world case discussions, researchers will gain practical knowledge essential for initiating or contributing to clinical research. Whether you are new to clinical trials or looking to strengthen your foundation, this workshop offers valuable insights and networking opportunities in a collaborative setting.

 

 

Clinical Trials Workshop: Wednesday, May 28, 2025
Location:  Stony Brook MART – Hospital Pavilion   4W-0101AC
Co-Sponsored by the RSOM Office of Faculty Affairs and the Stony Brook Center for Healthy Aging


Moderators: Styliani-Anna E. Tsirka, PhD, Vice Dean for Faculty Affairs, 51±¬ÁÏÍø of Medicine
Christine DeLorenzo, PhD and Suzanne Fields, MD, Interim Co-Directors, Center for Healthy Aging

 

Clinical Trials Workshop Agenda

9-9:10 am
 		 Welcome: Styliani-Anna Tsirka, PhD, SUNY Distinguished Professor, Miriam and David Donoho Professor, Pharmacological Sciences, Director, Scholars in BioMedical Sciences Program, Vice Dean for Faculty Affairs, RSOM
9:10-9:50 am

Overview of Clinical Trials: Annie Laurie Shroyer, PhD, MSHA, Professor, Department of Surgery
 

 Fundamentals of Clinical Trials: Structure and Design

  • Research Design, including hypothesis testing, randomization, and determining relevant outcomes
  • Reporting Results: Consort Guidelines
  • Investigator-initiated NIH-funded clinical trials versus industry/pharma-sponsored trials versus national collaboratives
  • Clinical Research Organizations: What they are, why you may need one, and how to work with them to know about their adults      

9:50-10:20 am

Opportunities for Collaboration in Clinical Trials: Joe Verghese, MD, MS, FRCPI, Professor and Chair, Department of Neurology

10:20-10:35 am  

Break

10:35- 11:30 am

 

Greetings from IRB Chairs: Marie Varela, Pharm D, MS, BCPS, Assistant Director of Pharmacy, Mary Saltz, MD, PhD, Clinical Professor, Departments of Radiology and Bioinformatics, Chief CIN Officer for Community Practice Initiatives, Stony Brook Cancer Center, Chief Medical Information Officer
 

Ethical Considerations: Rebecca Dahl, PhD, CIP, Assistant Vice President, Research Compliance, Research Integrity Officer, and Aimee Minton, CIP, Assistant Director, IRB, IRB/Quality Assurance Administrator

  • Ethical Issues in study design:  placebo vs. active control
  • SBU IRB versus central IRBs
  • Citi Program Training
  • Data safety and monitoring board committees

11:30-12:45 pm

Administrative Consideration
 
  • Data Analytics and Storage:  David Cyrille, Chief Research Information Officer, Assistant Vice President, Stony Brook University, DoIT and Monique Blakely,    
    Supervising Programmer Analyst, DoIT, Fang Wang, Data Brokered Services (30 minutes)
  • Recruitment and Retention of Patients:  Planning for, monitoring and retaining patients – Melanie Keister (Ripple and TriNetx) (20 minutes)
  • Planning a budget:  what you need to know – Bob Carter, Senior Financial Analyst for the Cancer Clinical Trials Office (20 minutes)
1-2:30 pm  Working Lunch
  Keynote Address: Getting started in Clinical Trials Research
Sharon Nachman, MD, Associate Dean for Research, Medical Director, Clinical Trials Office, Division Chief, Pediatric Infectious Diseases, Professor of Pediatrics, 51±¬ÁÏÍø of Medicine
 
  • Funding: Foundations, Industry, NSF, NIH, National Collaboratives
  • Phase I, II, III Trials
  • How to find out about trials in areas of interest
  • Finding a research mentor
  • How the Clinical Trials Office can help
  Clinical Trials Research as Scholarly Activity: Stony Brook Researchers involved in National Clinical Trials
Andreas P. Kalogeropoulos, MD, MPH, PhD, Director of Cardiovascular Research, The Stony Brook Heart Institute, Associate Professor of Medicine, 51±¬ÁÏÍø of Medicine
  Alison Stopeck, MD, Professor of Medicine, Associate Director of Clinical and Translational Research, Stony Brook Cancer Center
   
   
  Wrap Up: Q&A