ICTR June 2018 Newsletter                             
In This Issue

  • CRTP Graduation
  • ICTR on Stakeholder Engagement and Evaluation
  • Catalytic Seed Grant Funding Portal Now Open
  • NIH Definition of a Clinical Trial
  • Important Biorepository Updates
Future Leaders: CRTP Graduation
The Master of Science in Clinical Research Methods (CRTP) held its 19th commencement ceremony on May 22nd 2018 at the Pelham/Split Rock Golf Course where graduates were honored, along with their mentors and their families. The CRTP graduates come from all specialties and career stages, and have been trained in clinical research methods across the translational spectrum through didactic learning and coursework with a mentored research experience. Graduates and their departments include:

Jesus Anampa Mesias MD - Assistant Professor, Medicine (Oncology)
Sarah Baron MD - Assistant Professor, Medicine (Hospital Medicine)
Helena Blumen PhD - Assistant Professor, Medicine (Geriatrics) and Neurology
Anna Bortnick MD, PhD - Assistant Professor, Medicine (Cardiology)
Patrik Brodin PhD - Assistant Professor, Radiation Oncology
Michele Buonora - MD/MS Graduate
Anne Fuller MD - Fellow, Pediatrics (General Pediatrics)
Claudene George MD - Assistant Professor, Medicine (Geriatrics)
Alexander Latev MD - Emergency Medicine
Glenmarie Matthews MD - Fellow, OB/GYN and Women's Health (Family Planning)
Keneta McKellar - MD/MS Graduate
Kaitlyn Philips DO - Fellow, Pediatrics (Pediatric Hospital Medicine)
Michio Taya - MD/MS Graduate
Focusing on Stakeholder Engagement and Evaluation
David Lounsbury PhD , Assistant Professor, Departments of Epidemiology & Population Health and Family and Social Medicine is a community psychologist and psycho-oncologist whose academic work is directed towards health services research in prevention and control of chronic illnesses. Dr. Lounsbury has recently joined the ICTR as Director of Evaluation, using his expertise in stakeholder engaged research to drive learning healthcare system research projects through new stakeholder engagement studios. These studios will assemble a group of key stakeholders (patients, community members, healthcare providers, etc.) to provide feedback in order to enhance research design, planning, implementation, translation and dissemination to the Bronx community.
Seed Grant of of the Month
Welcome to a new item in the ICTR newsletter that will feature brief vignettes of the outcomes of our Pilot Project Program. First, some historical metrics—over the past decade the ICTR has awarded about $1.2 million in pilot and seed grants, with the remarkable result that subsequently the investigators submitted a total of 94 grants that ultimately generated about $20 million of extramural support , a nearly 17:1 return on investment. As importantly, these projects generated many new collaborations and innovations. To learn more and begin your application, click here .

For example, Dr. Ranaan Arens studies upper airway disorders in children. Obese children have a higher risk for obstructive sleep apnea syndrome (OSAS) with a prevalence of ~50%, and carries risks of neurocognitive, cardiovascular, and metabolic derangements. Dr. Arens is Chief of the division of Respiratory & Sleep Medicine in the department of Pediatrics. Despite progress in understanding the anatomical and functional aspects of OSAS, the precise mechanism remains unknown in the majority of obese children. A CTSA seed grant helped his team study obese 14-18 year old girls using polysomnography, airway pressure, and MRI. Currently, Dr. Arens’ R01 is funded to implement dynamic MRI and image analytics using fluid dynamics and biomechanical modeling to definitively establish the biomechanical basis of OSAS in obese children (1R01HL130468).
The Definition of a Clinical Trial
The NIH has released a decision tree graphic to help understand the definition of a clinical trial. Using four questions, investigators can more easily determine if their study is or is not a clinical trial. If the answers to the four questions (click on image to expand) are "yes", your study meets the NIH Definition of a clinical trial even if:

  • You are studying healthy participants
  • Your study does not have a comparison group (e.g., placebo or control)
  • Your study is only designed to assess the pharmacokinetics, safety, and/or maximum tolerated dose of an investigational drug
  • Your study is utilizing a behavioral intervention

To learn more about the NIH's definition of a clinical trial, click here .
Hot Off the Press: CTSA Renewal
Check out Einstein's home page and the latest issue of Einstein Magazine (Winter/Spring 2018) to learn more about the Einstein-Montefiore CTSA renewal and some of our new initiatives!
Biorepository News: Keep Your Precious Biospecimens Safe
A new 24/7 temperature monitoring system has been installed in the Einstein-Montefiore Biorepository . The system is a redundant one, in addition to the institutional freezer alarm notification system, since patient biospecimens are irreplaceable. Each -80º freezer unit has a NIST-calibrated probe monitoring the temperature at all times. This new system communicates monitors and records temperature wirelessly and communicates to with Biorepository staff, regardless of freezer location either at East Campus facility or at Moses Tower location. This system will alert the staff when freezer temperatures go out of range. In addition it provides the 24/7 temperature documentation for clinical research study specimens stored in the Biorepository, a requirement for any FDA-monitored study.
New Research Funding Opportunities from NORD
The National Organization for Rare Disorders has just released the availability of new grant to support the study of eight rare diseases. The initial application deadline will be July 16th 2018. To learn about NORD Rare Disease Research Grant Program, click here .
Bronx Community Event: Undesign the Redline
From May 1st to June 29th, the New York City Health Department's Bronx Neighborhood Health Action Center and Designing the We are hosting "Undesign the Redline" , an exhibit at the Bronx Health Action Center which focuses on the history of redlining in the Bronx and its effect on health in the community. The term "redline" began in the 1930s, when the U.S. government drew maps to decide which neighborhoods in cities across the country were too risky for mortgage loans, and areas made up of primarily people of color and recent immigrants were outlined in red. To schedule a guided tour or learn more , click here .

To watch an informative video on redlining, click here .
Research in the Headlines
Funding Opportunities
Harold and Muriel Block Institute for Clinical and Translational Research