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Topics in Clinical Research Seminar Series:


o Describe the career development process of a clinical investigator ... Clinical health care research is a systematic investigation intended to produce ... – PowerPoint PPT presentation

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Title: Topics in Clinical Research Seminar Series:

Topics in Clinical Research Seminar
Series Program Developed by The Office of
Clinical Research, Office of Clinical Trials, and
The General Clinical Research Center, The Albert
J. Finestone M.D. Office for Continuing Medical
Education     Clinical Research in an Academic
Medical Center     John Daly, MD Dean, Temple
University School Of Medicine   Objectives of
this Presentation o       Describe the career
development process of a clinical
investigator o       Discuss the types of grants
and award that are vital to the career
development of a clinical investigator o      
Demonstrate the benefits of Clinical Research at
an academic medical center
What is Clinical Research?
  • Clinical health care research is a systematic
    investigation intended to produce scientific and
    clinical knowledge for understanding disease,
    preventing and treating illness.

Importance of Clinical Research
  • Clinical research may improve existing
    technologies and produce new medicines for future
  • The research and development of a new drug is a
    logical, stepwise process in which data is
    collected from small clinical studies involving a
    human research participant population to support
    and guide long-term safety and efficacy trials
    that will eventually allow the registration and
    marketing of a new therapeutic tool.

  • Sound Clinical Research
  • depends on
  • Good Clinical Science
  • Good Statistical Design
  • Sound Ethical Conduct
  • Good Clinical (Research) Practices
  • An Industry Standard of International Significance

Types of Clinical Research
  • Industry-Supported Clinical Trial Phase I, II,
    III, IV
  • Pharmaceutical agent
  • Device
  • Investigator-Initiated Clinical Research
  • Industry
  • Society/Foundation
  • NIH R01, R03, etc
  • Unfunded (Department-Supported) Research

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Starting a Clinical Research Study
  • Protocol Development aim, hypothesis, methods,
  • Budget
  • Funding NIH, Industry, other
  • IRB approval protocol, ICF, HIPAA authorization
  • Medical Radiation Subcommittee
  • Pharmacy
  • IND
  • IBC
  • Contract
  • Sponsored Projects Administration Form (SPAF)
  • GCRC Advisory Committee

Steps in a Clinical Research Study
  • Create an Idea
  • State a Hypothesis
  • Learn the History (Literature Review)
  • Design an Experiment (Methods)
  • Collect Data
  • Analyze the Data
  • Test the Hypothesis

What is the Role of the IRB?
  • Asks four basic questions
  • Should the study be done at all?
  • Do the benefits outweigh the probable risks and
    is this information adequately conveyed in the
    consent form?
  • How will the research subject be protected?
  • How frequently do we need continuing review?

The General Clinical Research Center (GCRC)
  • Inpatient area
  • Outpatient area
  • Core laboratory
  • Informatic core
  • Bionutrition research core
  • Personnel Program director, nurses, support
  • Advisory Council

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Career Progression for MDs in Research
  • Finish clinical training
  • Do postdoctoral research (mentored)
  • (1 3 years)

Fellowship Grants (F,T)
Advance/nurture your career (3 - 5 years)
Career Development Awards (K)
Research grants (R)
Become an independent investigator
Clinical Research Career Development
  • Clinical Research Career Development programs of
    the NIH help maintain a cadre of biomedical
    researchers in the US. The NCRR Division of
    Clinical Research (DCR) participates in Clinical
    Research Career Development programs of the
    National Institutes of Health (NIH) primarily
    through its GCRC program.
  • These grant programs are designed to attract
    talented medical students, physicians, dentists,
    and similar professionals to the challenges of
    clinical research or to help clinical
    investigators transition to independent research

Typical NIH-funded Research Career Pathway
  • Medical Postgraduate Junior Experienced
  • School Faculty Faculty
  • T32 T32 K01 R01
  • F31 F32 K08, K23 K24
  • T35 K25
  • R03, R21

National Research Service Awards (NRSA)
  • This category of training support provides a
    stipend, or 'living expenses' allowance, to
    predoctoral students while they work toward their
    research degree, or to postdoctoral fellows while
    they obtain additional research experience in a
    mentor's laboratory.
  • Applicants must be U.S. citizens or permanent
    U.S. residents.

Individual Postdoctoral Fellowships (F32)
  • Provide up to three years of support for
    qualified individuals who have received a Ph.D.,
    M.D., or equivalent degree.
  • The award supports supervised research to enable
    biomedical scientists and clinicians to broaden
    their scientific backgrounds and expand their
    potential for research in health-related areas.
  • Prior to submission, an applicant must arrange
    for an appointment to an appropriate institution
    and acceptance by a sponsor who will supervise
    the training and research experience.
  • The institutional setting may be a domestic or
    foreign nonprofit, private or public institution,
    including the NIH. The postdoctoral fellow is the
    applicant on the application and award, and must
    participate in the planning of the research
    project proposed.

Individual Predoctoral Fellowships (F31) for
Minority Students and for Students with
  • Provide up to 5 years of support for research
    training leading to the Ph.D., or equivalent,
    research degree.
  • The intent of both programs is to encourage
    students from these groups to seek graduate
    degrees and thus increase the number of minority
    investigators and of persons with disabilities
    who are prepared to pursue careers in biomedical
    and behavioral science research.

Short-term Institutional Training Grants (T35)
  • Awarded to medical or other health professional
    schools to support summer research experiences
    for students between the first and second years
    of school.

Institutional Training Grants (T32)
  • Awarded to institutions with strong research
    programs to support a designated number of pre-
    or postdoctoral fellows, appointed by the
    training director at the institution.

Career Development AwardsThe K Awards
  • Career development awards provide salary and
    laboratory support for individuals who have
    completed their postdoctoral training, or who
    merely need 'protected time' at critical periods
    of their research careers.

K23 Mentored Patient-Oriented Research Career
Development Award
  • Provide physicians with up to 5 years of support
    to pursue more clinically oriented research
    careers directly involving patients. For early
    career physicians who have made a commitment to
    clinical/patient-oriented research.
  • The three to five years of supervised study and
    research supported by this award provide
    clinically trained professionals with an
    opportunity to develop independent research
    skills and to gain experience in advanced methods
    and experimental approaches needed to carry out
    patient-oriented research.
  • An eligible candidate must have (1) an M.D.,
    D.D.S., or equivalent (2) a mentor (3) a career
    development plan.

Mentored Clinical Scientist Development Awards
  • Provide physicians with up to 5 years of support
    to pursue research careers. Generally to work in
    a basic science laboratory, not for clinical
  • The Small Grant Program for NIDDK K08/K23
    Recipients allows NIDDK K08-holders to apply for
    up to 50,000 per year of extra research support
    in the final 2 years of their K08 to help in
    their transition to independence.

K12 Mentored Clinical Research Scholar (CRS) Award
  • Provides support to institutions to establish
    career development for physicians and dentists so
    they may develop the research skills necessary to
    become independent, clinical/patient-oriented
  • Candidates for the program are selected from
    among the recently trained physicians and
    dentists. Funds may be used to support full or
    partial completion of an advanced degree such as
    an MS, PhD, MPH.
  • The program must include activities that will
    provide candidates with a comprehensive
    understanding of clinical research approaches
    that are fundamental and not necessarily
  • The lead mentor, an established clinical
    researcher who holds a faculty position, will
    work closely with the candidate to develop a
    tailored career development plan.

K24 Midcareer Investigator Award in
Patient-Oriented Research
  • Provides support to established clinical
    investigators who are actively engaged in
    patient-oriented research and who serve as
    mentors for new clinical investigators.
  • Allows them protected time to (1) devote to
    clinical/patient-oriented research, (2) enhance
    their clinical research skills in order to
    conduct meritorious patient-oriented research,
    and (3) mentor beginning clinical investigators.
  • Target candidates are outstanding clinical
    scientists who are engaged in patient-oriented
    research, are within 15 years of their specialty
    training, can demonstrate the need for a period
    of intensive-research focus as a means of
    enhancing their clinical research careers, and
    are committed to mentoring.

  • Sound Clinical Research
  • depends on
  • Good Clinical Science
  • Good Statistical Design
  • Sound Ethical Conduct
  • Good Clinical (Research) Practices
  • An Industry Standard of International Significance

Some Benefits of Clinical Research to Temple
  • Patient Care
  • Improve patient care with new, state of the art,
  • Increase patient referrals for novel treatments
  • Academic
  • Investigators, especially in academics, want to
    be on the cutting edge
  • Retain top notch clinical and basic science
  • Increase prestige of TUSM, TUH, TUP
  • Financial
  • Increased financial revenue directly from trials
  • Salaries, study-related procedures, overhead
  • Downstream revenue to TUP, TUSM and TUH
  • Referred new patients from outside Temple
    system for studies
  • Increase new patient visits, increased
  • Patients that do not qualify often stay in TU

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Industry-Supported Clinical Research
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University Research Funding is largely through
Federal-Government Support
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NIH Director's Panel on Clinical Research (CRP)
1997 Report
  • The Panel's three-part definition "clinical
    research is
  • (a) Patient-oriented research. Research conducted
    with human subjects (or on material of human
    origin such as tissues, specimens and cognitive
    phenomena) for which an investigator (or
    colleague) directly interacts with human
    subjects. This area of research includes
  • Mechanisms of human disease
  • Therapeutic interventions
  • Clinical trials.
  • Development of new technologies
  • (b) Epidemiologic and behavioral studies
  • (c) Outcomes research and health services
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