University of California, San Francisco J. Claude Hemphill, III, MD New York Presbyterian Hospital Stephan Mayer, MD University of Cincinnati Arthur Pancioli, MD University of Maryland Barney J. Stern, MD University of Minnesota Michelle Biros, MD, MS University of Pennsylvania Jill Baren, MD, MBE University of Texas Elizabeth Jones, MD Virginia Commonwealth University Joseph P. Ornato, MD Wayne State University Robert Welch, MD University of California, Los Angeles Jeffrey Saver, MD and Sidney Starkman, MD Ohio State University Michel Torbey, MD Emory University David Wright, MD Henry Ford Health System Christopher Lewandowski, MD Medical College of Wisconsin Tom Aufderheide, MD University of Kentucky Roger Humphries, MD and Creed Pettigrew, MD Oregon Health & Science University Robert Lowe, MD, MPH and Craig Warden, MD University of Pittsburgh Clifton Callaway, MD, PhD and Jon Rittenberger, MD Temple University Nina Gentile, MD University of Arizona Kurt Denninghoff, MD SUNY Downstate Medical Center Steven Levine, MD Massachusetts General Hospital Joshua N. Goldstein, MD, PhD Stanford University James V. Quinn, MD CLINICAL COORDINATING CENTER (CCC) University of Michigan William Barsan, MD National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trial Group Robin Conwit, MD and Scott Janis, PhD STATISTICAL & DATA MANAGEMENT CENTER (SDMC) Medical University of South Carolina Yuko Palesch, PhD PARTICIPATING HUBS AND INVESTIGATORS Enrollment Update: As of 10-31-13 at 1:03p (EDT) ProTECT POINT SHINE Arizona 96 30 Not Acve Cincinna 85 79 7 Emory 92 40 31 HFH 17 39 <5 Kentucky 28 31 18 Maryland <5 26 5 Mass General <5 <5 <5 Minnesota 84 73 <5 NYP 5 46 34 Ohio State Not Acve Emmes 18 OHSU 31 39 <5 Pisburgh <5 <5 11 SUNY Downstate <5 31 <5 Stanford 87 52 <5 Temple 55 51 15 Texas 76 51 12 UCLA Not Acve Emmes <5 UCSF 23 41 <5 UPenn 70 160 <5 VCU 29 12 <5 Wayne State 28 87 <5 Wisconsin 73 29 <5 Emmes + Harrison (POINT only) - 855 - Ancillary Sites (SHINE only) - - 72 TOTAL 882 1776 252
University of California, San FranciscoJ. Claude Hemphill, III, MD
New York Presbyterian HospitalStephan Mayer, MD
University of CincinnatiArthur Pancioli, MD
University of MarylandBarney J. Stern, MD
University of MinnesotaMichelle Biros, MD, MS
University of PennsylvaniaJill Baren, MD, MBEUniversity of Texas
Elizabeth Jones, MDVirginia Commonwealth University
Joseph P. Ornato, MDWayne State University
Robert Welch, MD University of California, Los Angeles Jeffrey Saver, MD and Sidney Starkman, MD Ohio State University Michel Torbey, MD
Emory UniversityDavid Wright, MDHenry Ford Health System Christopher Lewandowski, MDMedical College of Wisconsin Tom Aufderheide, MDUniversity of KentuckyRoger Humphries, MD and Creed Pettigrew, MDOregon Health & Science UniversityRobert Lowe, MD, MPH and Craig Warden, MDUniversity of PittsburghClifton Callaway, MD, PhD and Jon Rittenberger, MDTemple University Nina Gentile, MDUniversity of Arizona Kurt Denninghoff, MDSUNY Downstate Medical Center Steven Levine, MDMassachusetts General HospitalJoshua N. Goldstein, MD, PhDStanford University James V. Quinn, MD
cliNical coordiNaTiNg cENTEr (ccc) University of MichiganWilliam Barsan, MD
National Institute of Neurological Disorders and Stroke (NINDS)
Clinical Trial GroupRobin Conwit, MD and Scott Janis, PhD
sTaTisTical & daTa maNagEmENT cENTEr (sdmc) Medical University of South Carolina
Yuko Palesch, PhD
ParTiciPaTiNg Hubs aNd iNvEsTigaTors
Enrollment Update: As of 10-31-13 at 1:03p (EDT) ProTECT POINT SHINE
Temple 55 51 15 Texas 76 51 12 UCLA Not Active Emmes <5 UCSF 23 41 <5 UPenn 70 160 <5 VCU 29 12 <5 Wayne State 28 87 <5 Wisconsin 73 29 <5 Emmes + Harrison (POINT only) - 855 - Ancillary Sites (SHINE only) - - 72
TOTAL 882 1776 252
Ethan Brandler, MD, MPH, FACEPSHINE Principlal InvestigatorSUNY DownstateDr. Brandler is an active EMS researcher in the area of pre-hospital stroke identification and works clinically as an emergency physician and as an academic hospitality. He is the site PI for SHINE at SUNY Downstate where he is also the EMS medical director. Dr. Brandler spends his free moments in his wood shop building toys with his children and practicing competitive kosher BBQ.
Ashika Jain, MDProTECT Principal InvestigatorSUNY DownstateDr. Jain joined the Department of Emergency Medicine at SUNY Downstate Hospital and Kings County Hospital after a myriad of trainings. After completing emergency medicine residency at Maimonides Medical Center in New York, she completed an Emergency Ultrasound fellowship, followed by a fellowship in Trauma Critical Care in Maryland at Shock Trauma Center, University of Maryland Medical Center. This is where her research interests in trauma and particularly neuro-trauma were harnessed. Trying to incorporate all of the above has become a research focus. In her off time, Dr. Jain tries to spend as much time with nature as possible, be it hiking, running, scuba diving or even just exploring Central Park with her dog.
Jennifer Martindale, MDSHINE Principal InvestigatorSUNY Downstate - Kings County HospitalDr. Martindale joined the Department of Emergency Medicine at SUNY Downstate/Kings County Hospital after graduating from the Harvard Affiliated Emergency Medicine Residency Program in 2012. She is interested in studying neurologic and cardiovascular emergencies. After having lived on both coasts incuding San Francisco, Los Angeles, and Boston, she is very excited to be living closer to her family in New York City.
Pleased to Meet You SUNY Downstate...
Sarah ZelonisNETT Hub Study CoordinatorSUNY DownstateSarah was welcomed into the NETT hub at SUNY Downstate in October 2012. Prior to joining the team in Brooklyn, Sarah garnered experience coordinating clinical trials in oncology at Columbia University Medical Center and various observational studies on the pediatric stroke population at the Children’s Hospital of Philadelphia. In her spare time, Sarah enjoys practicing Bikram Yoga, as well as seeing Broadway shows and exploring great new restaurants with her fiancé, Matt.
Pleased to Meet You (continued)...
Marijayne BusheyStudy Coordinator SUNY Downstate - Kings County HospitalBorn with superhuman powers of anal-retentiveness and attention to detail, Marijayne (Mj) was recruited to the NIH’s top-secret research superhero program in 1995, and given the code name Research Girl # 3.14 +/- .631. On her first assignment, .631 was stationed in Baltimore at the Johns Hopkins Colon Cancer Gene Testing Studies, part of the Bowel Tumor Working Group that not only birthed discoveries like APC I-1307-K, but also the legendary rock band Wild Type. After that, NIH undercover opps transferred her to Memorial Sloan Kettering in NYC, where she worked on the National Colonoscopy Study with the Colossal Colon to help bring down the likes of the nefarious Polyp Man. In 2013, .631 arrived at the KCHC arm of UHB to help the vigilant EM-Neuro teams there toe-the-line on NETT protocols. And she’ll continue to step up to the call of anal-retentive duty, saving the research universe, one protocol at a time.
The NETT will be represented at next month’s PRIM&R conference. Kudos to the following presenters:
• Poster: A descriptive review and analysis of the FDA docket on Public Disclosure Material for Emergency Research Studies conducted under 21 CFR 50.24 (Docket FDA-1995-S-0036)
Robert Silbergleit, Deneil Harney and Ben Hume• Poster: FDA Warning Letters Citing Exception from Informed Consent (EFIC) for Emergency Research Valerie Stevenson, Ronald Maio, Erin Bengelink, and Robert Silbergleit• Session: Emergency Research and Exception form Informed Consent (EFIC): Interesting Challenges and Les-
sons Learned About Community Consultation from a Multicenter Network (FDA Regulation Track) Michelle Biros, Neal Dickert, Sara F. Goldkind, and Deneil Harney• Flexible Adaptive Clinical Trial Designs: Understanding Such Designs, and Implications for Informed Consent
and IRB Review (Issues for Pharma/Biotech Track) Scott Berry and William J. Meurer
Christina CarrollATACH-II Monitor NETT Clinical Coordinating Center Christina Carroll is a native of Michigan with a background of Pre-Clinical and Human Clinical Research experience. Christina started her research career in 1998 in Neuroscience Therapeutics at Parke-Davis Warner Lambert (now Pfizer Pharmaceutical R & D) in Ann Arbor, Michigan. In 2009 Christina earned a position with the Internal Medicine Group at The University of Michigan Hospital in Clinical Research. She currently resides in Ypsilanti with her fiancé and daughter, Zoe. Christina enjoys traveling, fashion design, spending time with her family and teaching dance. -Christina Carroll [email protected]
Welcome The Newest NETT CCC Staff...
Carol VanHuysenPOINT and SHINE Monitor NETT Clinical Coordinating Center Carol graduated from Western Michigan University with a BS in Biology and began a research career at the Upjohn Company in Pathology and Toxicology. After relocating to Minnesota she worked for the Mayo Clinic doing assay development and protein metabolism research for the Dept. of Pediatric Endocrinology. Returning to Ann Arbor, she managed the Diabetes Research Program at the University of Michigan where her focus was redirected to clinical research. At the University of Michigan Institute for Clinical and Health Research she gained experience in study coordination, monitoring and project management. Prior to joining the NETT she developed the Children’s Health Initiative Program and was working to establish a tissue/data research platform for maternal and fetal health researchers. Outside of the NETT, she enjoys all creative endeavors with artwork focused on oil pastel and mixed media. She is the proud mom of two sons and is also an avid UM Football fan – Go Blue! -Carol VanHuysen [email protected]
Gina NeshewatPOINT Project ManagerNETT Clinical Coordinating CenterGina has a BA from Smith College and an MPH from the University of Michigan. Her research experience includes cognitive and behavioral therapy, chronic pain, endocrinology and diabetes, and now emergency medicine research. She resides in Ann Arbor and enjoys spending time with friends, hearing live music, dancing, and as of recent going to Michigan football games. An interesting fact about Gina is that she was a competitive weight lifter in high school. -Gina Neshewat [email protected]
