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

Ph.D.

Biostatisticians, Research Nurses, Study Coordinators, Project Managers, Administrators,

Educators, Informatics Specialists

Ph.D.

M.D.

M.D. – Ph.D.

Basic Science

Translational Research

Patient-Oriented Research

Public Health

Why is the Need for Physician-Scientists So Critical?

–Translational research–Clinical research informatics–Integrated clinical research networks–Training–New technologies, harmonizing regulatory processes –Establishing public trust

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:

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 approacheso Nanotechnology

More About the NIH Campus and the NIH

Clinical Center

NIH Clinical Center

• 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

The NIH Clinical Center“A Laboratory for Clinical Research”

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

• 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

Selected Historical 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

Recent Accomplishments

Interventional/Clinical Trials 655 (45%)

Natural History 700 (49%)

Screening 67 (5%)

Training 21 (1%)

TOTAL 1,443

Warren Grant Magnuson Clinical CenterProtocols by Research Type

March 2011

Phase I (toxicity) 224 (34%)

Phase II (activity) 377 (57%)

Phase III (efficacy) 39 (6%)

Phase IV (safety) 15 (3%)

TOTAL 655

Warren Grant Magnuson Clinical CenterInterventional/Clinical Trials by Phase

March 2011

SpecializedInfrastructure

• GMP facility for producing candidate drugs• Manufacturing capability (8 hour day)• Imaging equipment

• 3 cyclotrons• MRI center

• Biomechanics laboratory

• Blood products; stem cell technology

• Phenotyping

• IT Technology

Multi-modality minimally-invasive procedural suite

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

• 75,000 capsules

• 150,000 tablets

• 220 liters

• 5,000 syringes

• 8,000 vials (includes vaccines and biologics biologics)

Specialized Services and Infrastructure

Phenotyping

• Metabolic Unit• 10 beds - obesity• 3 metabolic suites• 1 body composition testing room

• Patients with Rare Diseases

Warren Grant Magnuson Clinical CenterSome Rare Diseases Studied at NIH

• Ankylosing Spondylitis• Autoimmune

LymphoproliferativeSyndrome (ALPS)

• Chediak-Higashi Syndrome • Chronic Granulomatous

Disease• Cushing Syndrome • Familial Hypereosinophilia• Familial Mediterranean Fever • Hutchison-Gilford Progeria

Syndrome

• 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 Gangrenosumand Acne (PAPA) Syndrome

• Smith-Lemli-Opitz Syndrome• Smith-Magenis Syndrome

Training

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.

Summer Internships

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

Clinical Center Summer Internships

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

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.

•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: Didactics

•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

•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: 2011-2012 Benefits

•Furnished accommodations, with utilities included, convenient to the NIH campus (no pets allowed)

two-bedroom, two-bath apartment for two single students orone-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

Clinical Research Training Program: Housing

Furnished Living Room and Bedroom

Kitchen and Dining Room

•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.

Clinical Research Training Program: Eligibility Criteria

SNMA Leaders and the CRTP

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

Michael G. Knight4th year Cleveland Clinic Lerner

College of Medicine of Case Western Reserve

SNMA National President 2011-2012CRTP Fellow 2010-2011

Lisa Green, M.D.OB/GYN Resident, Howard University

SNMA National President 2008-2009

CRTP Fellow 2008-2009

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 PatellofemoralPain 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

Dermatology

Diagnostic Radiology

Emergency Medicine

Internal Medicine

Internal Medicine / Pediatrics

Ophthalmology

Orthopaedic Surgery

Otolaryngology – Head and Neck Surgery

Pediatrics

Psychiatry

Radiation Oncology

Urology

Min DengUniversity of Chicago Medical Center

McKinley GloverMassachusetts General Hospital

Bobbak MansouriUniversity of California,San Francisco School of Medicine

Thomas McCannYale-New Haven Hospital

Chika ObeleNew York University School of Medicine

Zachary DezmanUniversity of Maryland Medical Center

So Yeon PaekHenry Ford Hospital (Detroit, MI)

Tu DanThomas Jefferson University Hospital (Philadelphia, PA)

Jeremy ForceIndiana University School of Medicine

Robert HuangStanford Hospital and Clinics

Sravan Kakani & Adam WaxmanUniversity of Pennsylvania Hospital

Berenice NavaJohns Hopkins University School of Medicine / Bayview Medical Center

Justin Taylor & Emily MaxsonBrigham & Women's Hospital

Lueng (Sophia) TcheungCedars Sinai Medical Center

Marc HeikensUniversity of Maryland Medical Center

Euna KooUniversity of California,San Francisco School of Medicine

Daniel BlandUniversity of Texas Southwestern Medical Center at Dallas

Stephanie ContagMayo Clinic (Rochester, MN)

Vishnu KannabiranBoston University Medical Center

Julianna PesceDavid Geffen School of Medicine / UCLA Medical Center

Paulomi MehtaYale-New Haven Hospital

Ellen LeeUniversity of Maryland Medical Center / Sheppard Pratt Health System

Paul ChungUniversity of Texas Southwestern Medical Center at Dallas

Jennifer RoblesWashington University in

St. Louis School of Medicine

Horacio DuarteUniversity of Washington School of Medicine

2009-2010 Clinical Research Training Program Match Results Graph

• 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

CRTP Composite Demographic Data

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.

Clinical Research Training Program

Michael G. Knight (2010-2011 CRTP Fellow)Cleveland Clinic Lerner College of Medicine of Case Western ReserveSNMA National President 2011-2012

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.

Clinical Research Training Program

Lisa Green, M.D.(2008-2009 CRTP Fellow)M.D., University of Maryland School of MedicineHoward University Hospital (Obstetrics and Gynecology )

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.

Clinical Research Training Program

Thomas Sanford, M.D.(2008-2009 CRTP Fellow)M.D., University of Hawaii, John A. Burns School of MedicineUniversity 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 ProgramYear-end Scientific Presentations

Clinical Research Training ProgramPoster Sessions

Year of Program Applied Invited for Interview Accepted

1997-1998 76 20 91998-1999 56 23 171999-2000 78 35 172000-2001 66 36 172001-2002 72 35 152002-2003 66 36 162003-2004 60 37 152004-2005 74 60 302005-2006 81 60 302006-2007 80 60 302007-2008 86 61 302008-2009 97 64 302009-2010 118 63 302010-2011 140 61 302011-2012 141 64 30

CRTP Application Data from 1997-2011

October 1 Application Site Opens

January 17 Application Deadline

Mid February Notification of Interview

Early March Interview Day

Mid-March Notification of Selection

Early April Deadline to Accept Offer (CRTP, HHMI, Sarnoff, and Doris Duke)

Early or mid-July or Students Arrive at the NIHearly or mid-August

2012-2013 CRTP Timetable

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_electives.html)

Clinical Electives Program

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

•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 clinician-scientists

Resident Electives

•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

Graduate Medical Education at NIH

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/careerdevelopmentawards.htm); K-08 and K-23 awards•K-99/R-00 (pathway to independence awards)-mentored and independent support

NIH Curriculum in Clinical Research

Master’s Degree in Clinical Research169 graduates since partnership began in 1998

Ethical and Regulatory Aspects of Human Subjects Research>4,258 participants since course began in 1999

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

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!