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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.

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funding investigator initiated research

Funding Investigator Initiated Research

David Cloutier, MS, MBA

Director, Research Center Management and Development

investigator initiated research iir
Investigator Initiated Research (IIR)
  • Research independently conceived and developed by scientists
  • Funded through intramural or extramural funds
  • Unfunded research
funding sources
FundingSources
  • 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
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
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
Federal Sources
  • National Institutes of Health branches http://www.nih.gov/icd/
  • Organizations subcontracting Federal awards
  • Grants.gov http://www.grants/gov

NCI

NEI

NHLBI

NIAA

NIAID

NIDCR

and many others

contingency funds
Contingency funds
  • Funds set aside from operating budgets to support research
  • Residual funds from sponsored clinical trials
marketing a research proposal
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
Small company collaboration
  • Small business look to acedemic sites
  • Expertise
  • Resources
  • Scientific and clinical leaders
  • SBIR / STTR opportunities
creighton resources
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 Trial Sites
  • Clinical trials offered to approved sites
    • Academic medical centers
    • Not-for-profit clinics
    • For profit clinics
    • Private practice
sub studies
Sub-Studies
  • “Piggybacking” additional research projects
  • Promote new research or outcomes from existing clinical trial
protocol development
Protocol Development
  • study hypothesis
  • study design
  • sample size requirements
  • statistical analysis plan
  • data collection forms
marketing a research proposal1
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
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
Contractual Issues
  • Intellectual property
  • Indemnification
  • Sponsorship
  • Progress
  • Authorship
publication bias
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
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 bias1
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
Methods of Minimizing Bias
  • Financial disclosure
  • Limiting sponsor control over publication
  • Registering clinical trials
  • Publishing negative results
registering clinical trials
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
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
Ex: Nursing

Nurse Researcher awards

Pediatric Cancer Nursing Practice

Links to opportunities for research funding

ex pediatric health
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
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
Ex: Latin American Health

Funding Sources: Mexico, Central America, Caribbean, and South America

Advancement of women’s human rights

ex surgery
Ex: Surgery
  • Professional Organizations

Stimulate original research in GI and endoscopic surgery

Bench or Clinical research

New investigator grants: detection, prevention of cardiovascular disease