Topics in Clinical Research Seminar Series:

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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
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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.

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Importance of Clinical Research

• Clinical research may improve existing
  technologies and produce new medicines for future
  patients.
• 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.

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

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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,
  analysis
• 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

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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

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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?

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The General Clinical Research Center (GCRC)

• Inpatient area
• Outpatient area
• Core laboratory
• Informatic core
• Bionutrition research core
• Personnel Program director, nurses, support
  staff
• 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
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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
  careers.

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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

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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.

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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.

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Individual Predoctoral Fellowships (F31) for
Minority Students and for Students with
Disabilities

• 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.

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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.

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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.

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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.

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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.

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Mentored Clinical Scientist Development Awards
(K08)

• Provide physicians with up to 5 years of support
  to pursue research careers. Generally to work in
  a basic science laboratory, not for clinical
  research.
• 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.

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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
  investigators.
• 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
  disease-specific.
• 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.

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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.

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

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Some Benefits of Clinical Research to Temple

• Patient Care
• Improve patient care with new, state of the art,
  agents/devices
• 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
  faculty
• 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
  procedures
• Patients that do not qualify often stay in TU
  system

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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
  research.