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Colleen Schmitt, MD, MHS Medical Director, Southeastern Clinical Research Galen Medical Group Chattanooga, Tennessee

Tracking Budgets & Trolling for Grants. Colleen Schmitt, MD, MHS Medical Director, Southeastern Clinical Research Galen Medical Group Chattanooga, Tennessee. Why Add Research to a Busy Practice?. Increase knowledge about diseases and therapies Enhance image

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Colleen Schmitt, MD, MHS Medical Director, Southeastern Clinical Research Galen Medical Group Chattanooga, Tennessee

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  1. Tracking Budgets & Trolling for Grants Colleen Schmitt, MD, MHS Medical Director, Southeastern Clinical Research Galen Medical Group Chattanooga, Tennessee

  2. Why Add Research to a Busy Practice? • Increase knowledge about diseases and therapies • Enhance image • Participate in scientific process • Access to new therapies • Alternative revenue stream Hjorth et al. Control Clin Trials 1996;17:372 Schmitt CM. J Clin Gastroenterol 2000;31:205

  3. Potential Revenue…How? Understand costs Understand payment structures Meet or exceed quota

  4. Hoping for a Pieceof the Pie Growth in R&D (Billions) PhRMA. Pharmaceutical Industry Profile 2007.

  5. Drug Development Process Phase II Phase III Phase IV www.phrma.org

  6. Impact on Research Practice 68 clinical trials per NDA 4,237 patients per NDA 141 procedures per patient PhRMA Annual Report, 2001

  7. Site Selection • 40% sites are new for any given trial • How to tap into the pipeline? • 91% top 25 Big Pharma use word-of-mouth and networking • 56% use external directories • 64% use internal database CenterWatch 2001;8:1

  8. Site Selection • Good Clinical Practice (GCP) • www.barnettinternational.com • www.socra.org • SCR GCP update @ utcomchatt.org • Ability to deliver • Therapeutic area expertise • Strong reputation

  9. Starting from Scratch • Track leads and sources • Feasibility questionnaires • Site CV’s and profile • Target: therapeutic area, sponsor, CRO • Metrics: enrollment, time to quota • Estimate site costs for activities • Fee-for-service basis • Hourly basis

  10. List Site or Profile • www.centerwatch.com • Study Brokers • www.invlocate.com • www.researchsite.net • www.clinicalinvestigators.com • Site Management Organizations (SMO) • www.americasdoctor.com • stark-smo.com • smo-usa.com Sites last accessed 05.July.2007

  11. Vendor R & D Directions CenterWatch PhRMA NDA Pipeline Clinical Investigator News Drug Development Pipeline Website www.biz-lib.com www.centerwatch.com www.phrma.org www.fdcreports.com www.ctbintl.com www.biopharminsight.com Sample Lead Sources

  12. Science Safety Feasibility Interest Financial Sponsor Opportunity for future work Idea for compound Therapeutic area Monitoring group Protocol Considerations "No, Thanks" Schmitt CM. Gastrointest Endosc Clin N Am 2006;16:751

  13. Be one of these! Meeting quota:Good Clinical Practice ECOG study • 62% investigators did not enroll any study subjects over the 1st year of study • 80% study subjects enrolled by 10% investigators • Fewer subjects=more errors Taylor KM, et al. J Clin Oncol 1994;12:1796

  14. Rules of Thumb for Budget • Everything is negotiable • Start with the protocol • Use the visit spreadsheet as rough draft • Scrutinize for undescribed work

  15. Meeting Quota:Good Business • Simple GERD trial • Budget = $1200 per subject, quota = 10 • Costs = $800 per subject + $1350 start-up

  16. Fee for Service • Full physical examination @ $200 • Brief physical examination @ $100 • Endoscopic procedures @ $1200 • Pelvic examinations @ $200 • DEXA scans, CXR, EKG @ $$ • Coordinator visit @ $100

  17. Budget Template

  18. ACRP (www.acrpnet.org) • DIA (www.diahome.org) Coordinator Costs • Base salary varies by education, experience, geography • Benefits 25% base salary • Time: long term studies (> 6 mos.), electronic CRF, adverse events, protocol amendments

  19. Where the Money Goes

  20. What’s Negotiable?

  21. Anything Else? • Ancillary personnel • Adverse events • Specimen retrieval for central review • Revisions to Case Report Forms (CRF) • Follow-up laboratory evaluation

  22. Money Pits • Overnight mail • On-site labs (pregnancy test, U/A) • Long term document storage • Attendance at investigator’s meeting • Telephone follow-ups and reminders • Electronic data collection • 50% > than paper CRF • Query resolution • Specimen retrieval

  23. Negotiate for Success • Communicate effectively • Base budget on protocol • Know your costs • Know your community and patient population • Understand your prior experience • Know when to say “no, thanks”

  24. Accounts Receivable • Beware scam payment systems based on • Blocks of patients • Query resolution at other sites • Database closure • Invoice frequently • Document all communication • Who, what, when, how

  25. Is the Future Rosy? PhRMA. New Drug Approvals in 2006 http://www.fda.gov/cder accessed 05.July.2007

  26. New Drug Approvals, 2004 • Of 29 Approvals in 2006, GI included: • Amitiza® (lubiprostone) • Pylera™ (biskalcitrate, TCN, metronidazole) • Sutent® (sunitinib) • Tyzeka® (telbivudine) • Veregen™ (kunecatechins) PhRMA. Pharmaceutical Industry Profile 2006.

  27. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Increased exportation of drug development in all clinical phases Increased generic share in the marketplace Importation of drugs via borders and internet Learning curve in litigation More About the Future

  28. Summary • Lead by example • Learn and live by Good Clinical Practices • Be responsible • Get involved • Require excellence

  29. “There are some things you learn about swinging a cat by the tail only by swinging a cat by the tail.” Mark Twain (paraphr.) Tom Sawyer, Abroad

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