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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). Research independently conceived and developed by scientists Funded through intramural or extramural funds Unfunded research.

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Funding Investigator Initiated Research

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  1. Funding Investigator Initiated Research David Cloutier, MS, MBA Director, Research Center Management and Development

  2. Investigator Initiated Research (IIR) • Research independently conceived and developed by scientists • Funded through intramural or extramural funds • Unfunded research

  3. 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

  4. 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)

  5. 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

  6. 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

  7. Contingency funds • Funds set aside from operating budgets to support research • Residual funds from sponsored clinical trials

  8. 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

  9. Small company collaboration • Small business look to acedemic sites • Expertise • Resources • Scientific and clinical leaders • SBIR / STTR opportunities

  10. 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

  11. Clinical Trial Sites • Clinical trials offered to approved sites • Academic medical centers • Not-for-profit clinics • For profit clinics • Private practice

  12. Sub-Studies • “Piggybacking” additional research projects • Promote new research or outcomes from existing clinical trial

  13. Protocol Development • study hypothesis • study design • sample size requirements • statistical analysis plan • data collection forms

  14. 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

  15. 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

  16. Contractual Issues • Intellectual property • Indemnification • Sponsorship • Progress • Authorship

  17. 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.

  18. 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.

  19. 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.

  20. Methods of Minimizing Bias • Financial disclosure • Limiting sponsor control over publication • Registering clinical trials • Publishing negative results

  21. 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/

  22. 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

  23. Ex: Nursing Nurse Researcher awards Pediatric Cancer Nursing Practice Links to opportunities for research funding

  24. Ex: Pediatric Health “…enhance the quality of life of infants and young children in nutrition, care, and development…” • Pediatric medical research • Early career awards

  25. 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

  26. Ex: Latin American Health Funding Sources: Mexico, Central America, Caribbean, and South America Advancement of women’s human rights

  27. Ex: Surgery • Professional Organizations Stimulate original research in GI and endoscopic surgery Bench or Clinical research New investigator grants: detection, prevention of cardiovascular disease

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