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Training Opportunities for Medical Students at the NIH

Frederick P. Ognibene, M.D. Deputy Director, Educational Affairs and Strategic Partnerships, NIH Clinical Center Director, NIH Clinical Research Training Program April 23, 2011

Spectrum of Clinical Research
Basic Science Translational Patient-Oriented Research Research Public Health

Ph.D. M.D. – Ph.D. M.D.

Ph.D.

Biostatisticians, Research Nurses, Study Coordinators, Project Managers, Administrators, Educators, Informatics Specialists

Why is the Need for Physician-Scientists So Critical?
Immediate Past NIH Director Elias A. Zerhouni, M.D. NIH Roadmap Initiative Reengineering the Clinical Research Enterprise A more efficient national clinical research system is needed to make rapid medical progress: –Translational research –Clinical research informatics –Integrated clinical research networks –Training –New technologies, harmonizing regulatory processes –Establishing public trust

Best Guess: Healthcare in 2020
• Almost everyone will know their genotype • Treatments will include gene therapy and stem cells • Many of today’s common diseases will be rare diseases with tailored therapy • Emphasis on chronic diseases

What Are the Opportunities?
• Integration of the human genome project into medicine/state-of-the-art clinical care • Understanding genome-environment interactions • Information technology • Role of microbiome in health and disease • Imaging technology to study/treat disease o Molecular approaches o Nanotechnology

More About the NIH Campus and the NIH Clinical Center

NIH Clinical Center

The NIH Clinical Center
“A Laboratory for Clinical Research”
• Opened in 1953 • More than 400,000 patients

since opening
• New Clinical Research Center

opened in April 2005
• 240 beds • 2,256 CC employees • 1,255 credentialed physicians • Over 1,400 active protocols • 2010 CC Budget: $377.5M

CC Motto:
“There’s No Other Hospital Like It”
• All patients are on a protocol

• No charge to patients and travel expenses supplemented • Highly educated nurses familiar with clinical research • Patient investment in clinical research process • Unique cohorts of patients • Long term and high risk studies • Specialized infrastructure

Mission
Science

Patient Care Training

Selected Historical Accomplishments
• Chemotherapy and immunotherapy for cancer • 1st platelet and granulocyte transfusions; 1st continuous flow blood cell separator • Lithium for bipolar disorders • Blood tests for AIDS, hepatitis • 1st gene therapy (ADA Deficiency) • Pathogenesis and treatment of AIDS • 1st successful artificial mitral heart valve • Immunosuppressive therapy for nonmalignant diseases • 1st fluoride gels to treat dental caries as an infectious disease

Recent Accomplishments
• Cardiac MRI in patients with chest pain to identify high-risk versus low-risk individuals • Use of adoptive transfer as immunotherapy for metastatic melanoma • First use of an immunotoxin to treat malignancy (hairy cell leukemia) • Demonstrated PET scans clarify some of the abnormalities in schizophrenia • Discovery of autoinflammatory diseases • Developed technology which led to vaccine for human papilloma virus

Warren Grant Magnuson Clinical Center Protocols by Research Type

Interventional/Clinical Trials 655 (45%) Natural History Screening Training TOTAL 700 (49%) 67 21 1,443
March 2011

(5%) (1%)

Interventional/Clinical Trials Warren Grant Magnuson Clinical Center by Phase
Phase I (toxicity) Phase II (activity) Phase III (efficacy) Phase IV (safety) TOTAL 224 377 39 15 655
March 2011

(34%) (57%) (6%) (3%)

Specialized Infrastructure

Specialized Services and Infrastructure
• GMP facility for producing candidate drugs • Manufacturing capability (8 hour day) • 75,000 equipment • Imagingcapsules • cyclotrons • 3 150,000 tablets • 220 liters • MRI center
• 5,000 syringes • 8,000 vials (includes vaccines and • Biomechanics laboratory biologics biologics)
Multi-modality minimally-invasive procedural suite

• Blood products; stem cell technology • Phenotyping • IT Technology

CC Pharmaceutical Development Section producing capsules of green tea for a study

Phenotyping
• Metabolic Unit • 10 beds - obesity • 3 metabolic suites • 1 body composition testing room • Patients with Rare Diseases

Warren Grant Magnuson Clinical Center

Some Rare Diseases Studied at NIH
• • • • • • • Hyper IgE (Job) Syndrome Muenke Syndrome Neurofibromatosis Type 1 Niemann-Pick Disease, Type C Neonatal Onset Multi-system Inflammatory Disease Osteogenesis Imperfecta Pyogenic Arthritis, Pyoderma Gangrenosum and Acne (PAPA) Syndrome Smith-Lemli-Opitz Syndrome Smith-Magenis Syndrome

• •

• • • • • •

Ankylosing Spondylitis Autoimmune Lymphoproliferative Syndrome (ALPS) Chediak-Higashi Syndrome Chronic Granulomatous Disease Cushing Syndrome Familial Hypereosinophilia Familial Mediterranean Fever Hutchison-Gilford Progeria Syndrome

• •

Training

Summer Internships
Students in high school, college, graduate programs, and nursing and medical schools are eligible to apply for paid summer research opportunities at the NIH Clinical Center and other Institutes/Centers in Bethesda, Maryland

•Application deadline was March 1st

Summer Internships
•Students work with research mentors, who include physicians and allied health professionals • Participate in the NIH Research Poster Festival-results generated by their work in the summer program •Attend weekly lectures presented by NIH investigators.

Clinical Center Summer Internships
•Exciting research opportunities in: •laboratory medicine •imaging sciences and radiology •nursing •rehabilitation medicine •anesthesiology •transfusion medicine and blood banking •critical care

Clinical Research Training Program
A public-private partnership established in 1997 and supported jointly by the National Institutes of Health (NIH) through its Roadmap initiative and the Foundation for the NIH (FNIH) with a grant from Pfizer Inc

Clinical Research Training Program
•Established in 1997 to train medical and dental students in clinical or translational research after completion of their clinical rotations •In 1998, Pfizer Inc became a partner with the NIH to support CRTP; 13th year of this public-private partnership.

Clinical Research Training Program
• Students are assigned a tutor, in their field of interest, who guides them in choosing a mentor for their research project. In addition, the tutor serves as an advisor for the academic year • Each student works with an established clinical and translational researcher who serves as a mentor for their year-long clinical or translational research projects.

Clinical Research Training Program: Didactics
•Twice a month seminar and journal club with clinical research discussions •Twice a month clinical teaching rounds •“Introduction to the Principles and Practice of Clinical Research” course •“Ethical and Regulatory Aspects of Human Subjects Research” course

Clinical Research Training Program
•Great Teachers Grand Rounds Series •Lectures with the HHMI-NIH Research Scholars (Cloister Program) •CRTP scientific presentations at end of academic year •CRTP poster sessions •Clinical or laboratory meetings with mentor and team

Clinical Research Training Program: 2011-2012 Benefits
•12-month stipend of $33,700 •Relocation expenses to and from Bethesda •Residential housing provided •Domestic conference travel expenses •Health insurance •Tuition support for scientific courses and textbooks •Dinners at CRTP clinical research seminar and journal clubs

Clinical Research Training Program: Housing
•Furnished accommodations, with utilities included, convenient to the NIH campus (no pets allowed) two-bedroom, two-bath apartment for two single students or one-bedroom, one-bath apartment for engaged or married couples •Parking expenses covered by CRTP •Close to public transportation •Affordable (average monthly rent for furnished two bedroom/two bath apartments in Bethesda, MD is approximately $2500) •CRTP fellows are required to live in the assigned residential housing for the entire 12-month period

Furnished Living Room and Bedroom

Kitchen and Dining Room

Clinical Research Training Program: Eligibility Criteria
•Candidates must be U.S. citizens or permanent residents •Candidates must be in good standing in medical, dental, or osteopathic school •Students must have approval from their Dean of Student Affairs to participate in this program

Clinical Research Training Program: Eligibility Criteria
•Candidates in M.D./Ph.D. programs are eligible to apply •Prior publications and research are desirable but not required

Clinical Research Training Program: Eligibility Criteria
All 4th year applicants who are selected to participate in the CRTP must make arrangements with their medical school to defer graduation until after completing the CRTP fellowship. This requirement must be met prior to starting the CRTP at NIH.

SNMA Leaders and the CRTP

Brandi K. Freeman, M.D. Pediatrics Resident, Johns Hopkins University SNMA National President 2006-2007 CRTP Fellow 2006-2007

Lisa Green, M.D. OB/GYN Resident, Michael G. Knight Howard University SNMA National President 4th year Cleveland Clinic Lerner College of Medicine 2008-2009 of Case Western Reserve CRTP Fellow 2008-2009 SNMA National President 2011-2012 CRTP Fellow 2010-2011

SNMA Leaders and the CRTP

Past and present SNMA leaders and CRTP administrator and director at last year’s SNMA annual conference with Dr. Freda Lewis-Hall, Executive Vice President, Chief Medical Officer, Pfizer Inc

2010-2011 Clinical Research Training Program Fellows
Active SNMA Members •Michael Knight •Nnenaya Agochukwu •Nneamaka Agochukwu •Martha Amoako •Candace Mainor

2010-2011 CRTP Medical Schools Represented
• • Boston University School of Medicine Case Western Reserve University School of Medicine Cleveland Clinic Lerner College of Medicine of Case Western Reserve University David Geffen School of Medicine at UCLA Duke University School of Medicine • • Finch University-Chicago Medical School Johns Hopkins University School of Medicine Louisiana State University School of Medicine (Shreveport) Medical College of Georgia New York University School of Medicine

• • •

2010-2011 CRTP Medical Schools Represented
• UMDNJ-Robert Wood Johnson Medical School University of Arkansas School of Medicine University at Buffalo State University of New York School of Medicine & Biomedical Sciences University of California, San Diego School of Medicine University of California, San Francisco School of Medicine • • University of Kentucky College of Medicine

• •

University of Maryland School of Medicine

University of Miami Leonard M. Miller School of Medicine

• •

University of Michigan Medical School University of North Carolina at Chapel Hill School of Medicine Vanderbilt University School of Medicine

Examples of 2010-2011 Clinical Research Projects
Correlation of Early MRI Biomarkers with Clinical Outcomes in Patients with Recurrent Malignant (Grade III/IV) Gliomas Treated with Bevacizumab The Role of Patellofemoral Kinematic and Kinetic Parameters in Patellofemoral Pain Syndrome Longitudinal Study of Retinal Angiomatosis and Visual Function in Ocular von Hippel-Lindau Disease

2009-2010 Clinical Research Training Program Fellows
Active SNMA Members •McKinley Glover •Chika Obele

2009-2010 Clinical Research Training Program Match Results Graph
Min Deng University of Chicago Medical Center Horacio Duarte University of Washington School of Medicine Stephanie Contag Mayo Clinic (Rochester, MN) Jeremy Force Indiana University School of Medicine So Yeon Paek Henry Ford Hospital (Detroit, MI) Paulomi Mehta Yale-New Haven Hospital Tu Dan Thomas Jefferson University Hospital (Philadelphia, PA) Thomas McCann Yale-New Haven Hospital Justin Taylor & Emily Maxson Brigham & Women's Hospital McKinley Glover Massachusetts General Hospital

Euna Koo University of California, San Francisco School of Medicine

Jennifer Robles Washington University in St. Louis School of Medicine Marc Heikens University of Maryland Medical Center

Vishnu Kannabiran Boston University Medical Center Chika Obele New York University School of Medicine Sravan Kakani & Adam Waxman University of Pennsylvania Hospital Berenice Nava Johns Hopkins University School of Medicine / Bayview Medical Center Zachary Dezman University of Maryland Medical Center Ellen Lee University of Maryland Medical Center / Sheppard Pratt Health System

Paul Chung University of Texas Southwestern Medical Center at Dallas Julianna Pesce David Geffen School of Medicine / UCLA Medical Center Lueng (Sophia) Tcheung Cedars Sinai Medical Center Robert Huang Stanford Hospital and Clinics Bobbak Mansouri University of California, San Francisco School of Medicine Daniel Bland University of Texas Southwestern Medical Center at Dallas

Dermatology Diagnostic Radiology Emergency Medicine

Internal Medicine Internal Medicine / Pediatrics Ophthalmology

Orthopaedic Surgery Otolaryngology – Head and Neck Surgery Pediatrics

Psychiatry Radiation Oncology Urology

CRTP Composite Demographic Data

• 340 students (335 medical, 5 dental) • 81 medical schools, 4 dental schools, and 2 osteopathic schools • 15 former CRTP fellows will have returned to the NIH for fellowships by July 2011

Clinical Research Training Program
My experience at the NIH as a CRTP Fellow has been truly remarkable. As a future physician scientist, I knew that I wanted to spend additional time during medical school to strengthen my foundation in scientific inquiry. What I didn’t know was that the CRTP experience would offer all of that, and much more. This year has had a significant impact on my personal and professional development. I highly recommend this phenomenal opportunity. Michael G. Knight (2010-2011 CRTP Fellow) Cleveland Clinic Lerner College of Medicine of Case Western Reserve SNMA National President 2011-2012

Clinical Research Training Program
As an aspiring physician scientist, becoming a CRTP fellow was one of the best decisions I have ever made. This program delivered the perfect combination of clinical medicine, research exposure, and networking opportunities. My research experience and the relationships that I formed have helped me to grow both personally and professionally. I consider myself a very proud alumnus and I am thankful for this opportunity. Lisa Green, M.D. (2008-2009 CRTP Fellow) M.D., University of Maryland School of Medicine Howard University Hospital (Obstetrics and Gynecology )

Clinical Research Training Program
CRTP gave me a lot more than the opportunity to train at a good residency program. It allowed me to see what an exciting, fulfilling life physician scientists lead. Now, I realize the kinds of opportunities I will have to learn more about research so that one day I may be able to make a significant impact on a disease process. I remain very grateful for the opportunity I had to spend a year at the NIH.
Thomas Sanford, M.D. (2008-2009 CRTP Fellow) M.D., University of Hawaii, John A. Burns School of Medicine University of California, San Francisco School of Medicine (Urology)

Joshua Joseph, M.D. (2006-2007 CRTP Fellow, Boston University School of Medicine) Performing a Cardiovascular Physiology Study

Clinical Research Training Program Year-end Scientific Presentations

Clinical Research Training Program Poster Sessions

CRTP Application Data from 1997-2011
Year of Program 1997-1998 1998-1999 1999-2000 2000-2001 2001-2002 2002-2003 2003-2004 2004-2005 2005-2006 2006-2007 2007-2008 2008-2009 2009-2010 2010-2011 2011-2012 Applied 76 56 78 66 72 66 60 74 81 80 86 97 118 140 141 Invited for Interview Accepted 20 23 35 36 35 36 37 60 60 60 61 64 63 61 64 9 17 17 17 15 16 15 30 30 30 30 30 30 30 30

2012-2013 CRTP Timetable
October 1 January 17 Mid February Early March Mid-March Early April Early or mid-July or early or mid-August Application Site Opens Application Deadline Notification of Interview Interview Day Notification of Selection Deadline to Accept Offer (CRTP, HHMI, Sarnoff, and Doris Duke) Students Arrive at the NIH

Clinical Electives Program
Fourth year medical students •The Clinical Electives Program (CEP) at the National Institutes of Health currently offers 33 rotations in a wide range of clinical disciplines as well as individualized tutorials for students who desire a total research experience. •Electives are typically either 4-or-8 weeks •On-line application
(http://www.cc.nih.gov/training/students/clinical_elec tives.html)

Clinical Electives Program: List of Rotations
•Alcoholism •Cardiology •Clinical Pharmacology and Therapeutics •Critical Care Medicine •Endocrinology and Metabolism •Gynecology Consult Service •Health Services •Hematology •Hepatology •Infectious Diseases •Interdisciplinary Women’s Health •Internal Medicine Consult •Medical Informatics •Medical Oncology •Neurology •Nuclear Medicine •Neurosurgery •Otolaryngology

Clinical Electives Program: List of Rotations
•Pain and Palliative Care •Pathology •Pediatric Consult •Pediatric Endocrinology •Pediatric Oncology •Pediatric Psychopharmacology •Psychiatry •Radiation Oncology •Rehabilitation Medicine •Rheumatology •Sickle Cell Anemia •Surgical Oncology •Transfusion Medicine •Urologic Oncology

FDA Clinical Pharmacology Rotation
•Coordinated by Juan Lertora, M.D., Ph.D. •Opportunity for clinical investigators to learn about - FDA drug development procedures - Investigational New Drug Application process

Resident Electives •4-to 8-week clinical electives in selected medical specialties •Residents in ACGME-accredited training programs •Comprehensive experience in the care of research subjects enrolled in investigational protocols under the mentorship of NIH clinicianscientists

Graduate Medical Education at NIH
•The NIH Clinical Center is fully accredited by the Accreditation Council of Graduate Medical Education (ACGME) as the sponsoring institution for GME on the NIH campus •18 ACGME accredited specialty or subspecialty training programs •Additional support for jointly sponsored ACGME programs •Many other non-ACGME clinical fellowships •Variable lengths of training

ACGME Accredited NIH Programs
• Allergy and Immunology • Anatomic Pathology • Critical Care Medicine • Cytopathology • Endocrinology and Metabolism • Hematology • Hematopathology • Hospice and Palliative Medicine • Infectious Diseases • Medical Biochemical Genetics • Medical Genetics • Medical Oncology • Neurosurgery • Pediatric Endocrinology • Psychiatry (PGY-4) • Rheumatology • Transfusion Medicine/Blood Banking • Vascular Neurology

Jointly Sponsored ACGME-Accredited Programs •Clinical Neurosciences-Clinical Neurophysiology •Gastroenterology •Pediatric Hematology-Oncology •Pediatric Medical Genetics •Radiation Oncology

Other Fellowship Options
• Alcoholism • Child Psychiatry • Clinical Neurosciences (neurocardiology, epilepsy research, human cortical physiology, motor control, neuroimmunology, stroke, and surgical neurology) • Reproductive Endocrinology • Deafness and Communication Disorders • HIV and AIDS Malignancy • Human Genetics • Neuro-Oncology • Nephrology • Surgical Oncology • Uveitis and Ocular Immunology

Career Transitions

•Clinical Assistant Investigator •Tenure-track •Tenured Senior Investigator •K-awards (career development awards http://grants1.nih.gov/training/careerdevelo pmentawards.htm); K-08 and K-23 awards •K-99/R-00 (pathway to independence awards)-mentored and independent support

NIH Curriculum in Clinical Research

Introduction to the Principles & Practice of Clinical Research >10,527 participants since course introduced in 1995 Principles of Clinical Pharmacology >6,626 registrants since course began in 1998

Ethical and Regulatory Aspects of Human Subjects Research >4,258 participants since course began in 1999 Master’s Degree in Clinical Research 169 graduates since partnership began in 1998

April 2011

NIH Contact Information
• NIH Clinical Center Homepage http://www.cc.nih.gov/ • Overview of fellowship training opportunities http://www.cc.nih.gov/training/ • NIH Homepage http://www.nih.gov/ • General questions: 1.888.695.5343 or 301.496.9425 • Dr. Frederick Ognibene fognibene@cc.nih.gov • Mr. Kenny Williams williajk@mail.nih.gov

Thank you and enjoy Naptown!