Title: Topics in Clinical Research Seminar Series:
1Topics in Clinical Research Seminar
Series Program Developed by The Office of
Clinical Research, Office of Clinical Trials, and
The Department Of Medicine Research
Committee   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     Â
Demonstrate the benefits of Clinical Research at
an academic medical center
2What 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.
3NIH 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.
4- Sound Clinical Research
- depends on
- Good Clinical Science
-
- Good Statistical Design
-
- Sound Ethical Conduct
5Types 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
6Steps 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
7Starting a Clinical Research Study
- Protocol Development aim, hypothesis, methods,
analysis - Budget Funding NIH, Industry, other
- IRB approval protocol, HIPAA authorization
- Contract
- Sponsored Projects Administration Form (SPAF)
- GCRC Advisory Committee
8Career Progression for MDs in Research
- Clinical research career during 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
9Typical NIH-funded Research Career Pathway
- Medical Postgraduate Junior Experienced
- School Faculty
Faculty Faculty
- T32 T32 K01 R01
- F31 F32 K08, K23 K24
- T35 K25
- R03, R21
10National 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.
11Individual Postdoctoral Fellowships (F32)
- Provide up to three years of support for Ph.D.,
M.D., or equivalent degree. - Supervised research to enable biomedical
scientists and clinicians to broaden their
scientific backgrounds and expand their potential
for research in health-related areas. - Applicant must arrange for appointment to an
appropriate institution and acceptance by a
sponsor who will supervise the training and
research experience. - Institutional setting may be domestic or
foreign, private or public institution, including
the NIH. The postdoctoral fellow must participate
in the planning of the research project proposed.
12Individual 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.
13Institutional 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.
14Short-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.
15Career 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.
16K23 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.
17Mentored 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.
18K12 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 recently trained physicians and
dentists. Funds used to support full or partial
completion of an advanced degree such as an MS,
PhD, MPH. - Program include activities that provide
candidates with comprehensive understanding of
clinical research approaches that are
fundamental. - 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.
19Some 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
20- At end of Fiscal Year 06 there were
- 149 open trials funded by pharmaceutical
companies. - This represents an increase of 51 (52) over the
base year (FY 2002-03) and a net increase of 33
(29) open trials over FY 04.
21- The 149 open trials are being conducted by 72
investigators. - The vast majority of these investigators (67 or
93) and trials (141 or 95) come from the School
of Medicine.
22Office of Clinical Trials
- It is one of the goals of OCT to continue to
provide support to investigators in all of the
Health Science Center to expand the clinical
trial activity of the other schools.
23 24Clinical 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.
25K24 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.
26- Sound Clinical Research
- depends on
- Good Clinical Science
-
- Good Statistical Design
-
- Sound Ethical Conduct
- Good Clinical (Research) Practices
- An Industry Standard of International Significance
27Industry-Supported Clinical Research
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29University Research Funding is largely through
Federal-Government Support
30Importance 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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32The General Clinical Research Center (GCRC)
- Inpatient area
- Outpatient area
- Core laboratory
- Informatics core
- Bionutrition research core
- Personnel Program director, nurses, support
staff - Advisory Council
33What 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?