Research in Clinical Practice Risk or Reward临床实践风险或报酬的研究.pptVIP

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 Participate in scientific process Access to new therapies Alternative revenue stream Potential Revenue…How? Hoping for a Pieceof the Pie Drug Development Process Impact on Research Practice 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 Site Selection Good Clinical Practice (GCP) SCR GCP update @ Ability to deliver Therapeutic area expertise Strong reputation 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 List Site or Profile Study Brokers Site Management Organizations (SMO) Sample Lead Sources Vendor R D Directions CenterWatch PhRMA NDA Pipeline Clinical Investigator News Drug Development Pipeline Website Protocol Considerations Science Safety Feasibility Interest Financial Sponsor Opportunity for future work Idea for compound Therapeutic area Monitoring group 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 Rules of Thumb for Budget Everything is negotiable Start with the protocol Use the visit spreadsheet as rough draft Scrutinize for undescribed work Meeting Quota:Good Business Simple GERD trial Budget = $1200 per subject, quota = 10 Costs = $800 per subject + $1350 start-up Fee for Service Full physical examination @ $200 Brief physical examination @ $100 Endoscopic procedures @ $1200 Pelvic examinations @ $200 DEXA scans, CXR, EKG @ $$ C