Transcript Funding Investigator Initiated Research

Funding Investigator Initiated
Research
David Cloutier, MS, MBA
Director, Research Center
Management and Development
Investigator Initiated Research (IIR)
• Research independently conceived and
developed by scientists
• Funded through intramural or extramural
funds
• Unfunded research
Funding Sources
• Creighton University funds designated for
the conduct of investigator-initiated
research, e.g. Health Future Foundation
• Not-for-profit and private organizations
• For-profit Industry support
• Contingency funds
Internal Sources
• Health Future Foundation
– Faculty development grants, 1 or 2 year term
– Applicants must be full-time faculty at the time
of application
• LB 595, LB-692
– Nebraska Tobacco Settlement Biomedical
Research Program (LB-595 and LB-692)
Not-for-Profit / Private Resources
• Many organizations exist per disease or
therapeutic area
• Typically must address a set of company
specific areas of interest
• Many accept solicited and unsolicited
applications
• Applications must be reviewed by Sponsored
Programs Administration prior to submission
Federal Sources
• National Institutes of Health branches
http://www.nih.gov/icd/
NCI
NEI
NHLBI
NIAA
NIAID
NIDCR
and many others
• Organizations subcontracting Federal awards
• Grants.gov http://www.grants/gov
Contingency funds
• Funds set aside from operating budgets to
support research
• Residual funds from sponsored clinical
trials
Marketing a Research Proposal
• Review clinical trials of interest on
clincialtrials.gov
Contact sponsoring company / agency
• Meet with pharmaceutical & device sales
representatives and scientists
• Review financial support footnotes in
publications
• Internet keyword searches
Small company collaboration
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Small business look to acedemic sites
Expertise
Resources
Scientific and clinical leaders
SBIR / STTR opportunities
Creighton Resources
• Creighton University offers research and
Compliance services that small
businesses admire
 Project
Management
 Contracting
 Budget
development
 IRB
 SPA
 Research and
Compliance
oversight
 Statistics
 Data collection
services
Clinical Trial Sites
• Clinical trials offered to approved sites
– Academic medical centers
– Not-for-profit clinics
– For profit clinics
– Private practice
Sub-Studies
• “Piggybacking” additional research
projects
• Promote new research or outcomes from
existing clinical trial
Protocol Development
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study hypothesis
study design
sample size requirements
statistical analysis plan
data collection forms
Marketing a Research Proposal
• Demonstrate interest with a short protocol
• Demonstrate alignment with sponsor goals
• Initial contact through Sales, passed on to
Medical Science Liaison
• Executive & Scientific committee review
– Proposal
– Budget
Feasibility
• Review for threats to study success, and to
determine if changing the focus of the study can
eliminate these risks
– Budgetary
• Salary support for investigator and staff
• Procedural costs
– Logistical
• Appropriate space, personnel, and patient population
– Clinical
• Adequate diagnostic testing services and equipment
Contractual Issues
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Intellectual property
Indemnification
Sponsorship
Progress
Authorship
Publication Bias
Objective
To investigate whether funding of drug studies by the pharmaceutical industry
is associated with outcomes that are favorable to the funder and whether the
methods of trials funded by pharmaceutical companies differ from the methods
in trials with other sources of support.
Results 30 studies were included. (3248 / 3351 studies did not mention
funding source)
– Research funded by drug companies was less likely to be published
than research funded by other sources.
– Studies sponsored by pharmaceutical companies were more likely to
have outcomes favoring the sponsor than were studies with other
sponsors.
– None of the 13 studies that analyzed methods reported that studies
funded by industry was of poorer quality.
Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research
outcome and quality: Systematic review. BMJ. 2003;326:1167–1170.
Publication Bias (cont.)
Conclusion
– Systematic bias favors products which are made by the
company funding the research
– Explanations include the selection of an inappropriate
comparator to the product being investigated and publication
bias.
Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship
and research outcome and quality: Systematic review. BMJ. 2003;326:1167–1170.
Publication Bias
– Industry provides twice as much funding for clinical
trials and related research as do not-for-profit
agencies 1
– 70% of industry funding paid to Clinical Research
Organizations for management of clinical trials 2
– 30% of industry funding that goes to academic
researchers 2 often includes sponsor control of
publication
• Limiting access to data, delays in publication, and draft edits.
[1] Bodenheimer T. Uneasy alliance: Clinical investigators and the pharmaceutical industry. New Engl J Med. 2000;342:1539–1544.
[2] Mirowski P, Van Horn R. The contract research organization and the commercialization of scientific research. Soc Stud Sci.
2005;35:503–534.
Methods of Minimizing Bias
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Financial disclosure
Limiting sponsor control over publication
Registering clinical trials
Publishing negative results
Registering Clinical Trials
• Reported bias has led to a universal call
for registration of all clinical trials,
regardless of funding source.
• Many journals require trial registration
http://prsinfo.clinicaltrials.gov/
Pharmaceutical Company
Grants
Hemophilia, BioTherapeutics, BioSurgery
Brochure link
Child Health, Access to Healthcare, Underserved pop.
Brochure link
Cardiology: Dyslipidemia, ACS
Endocrinology: T2DM
Infectious disease
Pain / OIC
Pediatric Fellowships
COPD / Asthma
Ex: Nursing
Nurse Researcher awards
Pediatric Cancer Nursing Practice
Links to opportunities for research funding
Ex: Pediatric Health
“…enhance the quality of life of infants and young
children in nutrition, care, and development…”
• Pediatric medical research
• Early career awards
Ex: Dentistry
Research and Education Fund
Health, education and research
projects in dentistry, health and human
services, and civic and community
affairs
Research and Education
Currently 13 award categories
Ex: Latin American Health
Funding Sources: Mexico, Central America, Caribbean, and South America
Advancement of women’s human rights
Ex: Surgery
• Professional Organizations
Stimulate original research in GI and endoscopic surgery
Bench or Clinical research
New investigator grants: detection,
prevention of cardiovascular disease