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US Clinical Research

US Clinical Research. 3 rd Clinical Research Management Workshop June 21, 2010 Originally presented at the IOM Drug Forum Clinical Trials Workshop, October 7, 2009 Ronald Krall , MD Krallrl@msn.com. Conflict of Interest Disclaimer.

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US Clinical Research

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  1. US Clinical Research 3rd Clinical Research Management Workshop June 21, 2010 Originally presented at the IOM Drug Forum Clinical Trials Workshop, October 7, 2009 Ronald Krall, MD Krallrl@msn.com IOM Drug Forum Clinical Trials Workshop - R Krall

  2. Conflict of Interest Disclaimer • Associate Fellow, Center for Bioethics, University of Pennsylvania • Consultant to • Frazier Healthcare Venture • Bogart, Delafield & Ferrier, LLC • GlaxoSmithKline • Consultant and investor, Naurex, Inc. • Member, Executive Board, Observational Medical Outcomes Partnership, FNIH • Previous positions with Lorex, Abbott, Zeneca, AstraZeneca, GlaxoSmithKline; Retired IOM Drug Forum Clinical Trials Workshop - R Krall

  3. Acknowledgements • Institute of Medicine Grant • Emily R. Krall, Research Associate • Deborah Zarin, Nicholas Ide, ClinicalTrials.gov, National Library of Medicine • Scott Martin, KMR • Alex Lancksweert, GSK IOM Drug Forum Clinical Trials Workshop - R Krall

  4. Outline • Rationale • Study • Methods • Findings • Observations IOM Drug Forum Clinical Trials Workshop - R Krall

  5. Rationale/Premise • Learning Healthcare System • requires mechanism for acquiring information to inform policy and practice • Many kinds of evidence can inform, but the gold standard will remain controlled clinical trials • What’s the US capability to conduct controlled clinical trials? • Does the current capability meet the needs? IOM Drug Forum Clinical Trials Workshop - R Krall

  6. Study Questions • How much clinical research is being conducted in the US? • How many trials? • How many subjects? • What kind of research? • Interventions • Diseases • Innovation • Who is carrying out the research? • Where is the research being conducted? • How effective is it? IOM Drug Forum Clinical Trials Workshop - R Krall

  7. Study Questions • How much clinical research is being conducted in the US? • How many trials? • How many subjects? • What kind of research? • Interventions • Diseases • Innovation IOM Drug Forum Clinical Trials Workshop - R Krall

  8. Study Methods – Sources of Data • Clinicaltrials.gov IOM Drug Forum Clinical Trials Workshop - R Krall

  9. Clinicaltrials.gov Efficacy trials for “serious and life-threatening” conditions; and interventions regulated by FDA FDA Modernization Act 1997 Registration required for publication ICMJE Legal requirement for registration of trials of drugs, biologics, devices FDA Amendments Act 2007 IOM Drug Forum Clinical Trials Workshop - R Krall

  10. Clinicaltrials.gov Data Elements • Title • FDA Information • Human Subject Review • Sponsors • Study Description • Status • Study Design • Arms, Groups and Interventions • Conditions and Keywords • Eligibility • Protocol Location, Contact and Investigator Information • Related Information IOM Drug Forum Clinical Trials Workshop - R Krall

  11. Clinicaltrials.gov Clinical Trials Datasets • Ongoing • “Open” • Interventional • At least one US Center • As of August 16, 2009 IOM Drug Forum Clinical Trials Workshop - R Krall

  12. Study Questions • How much clinical research is being conducted in the US? • How many trials? • How many subjects? • What kind of research? • Interventions • Diseases • Innovation • Who is carrying out the research? • Where is the research being conducted? • How effective is it? IOM Drug Forum Clinical Trials Workshop - R Krall

  13. Study Methods – Sources of Data • Clinicaltrials.gov • Completed in 2008 • Interventional • Trials with at least one US Center • Completed in the year 2008 • As of July 31, 2009 • Survey of investigators who completed trials in 2008 • Tufts Center for Study of Drug Development Impact Report on Investigators • KMR • Specific pharmaceutical company data IOM Drug Forum Clinical Trials Workshop - R Krall

  14. Tufts Center for Study of Drug Development Data • FDA Bioresearch Monitoring Information System • 1572 Forms – investigators • Annual analysis since 1990 • Source: • Ken Getz, Stephanie Rochon, Rachel Zuckerman • Impact Report, Volume 11, Number 1, January/February, 2009 IOM Drug Forum Clinical Trials Workshop - R Krall

  15. How much clinical research is being conducted in the US?What kind of research? IOM Drug Forum Clinical Trials Workshop - R Krall

  16. Ongoing US Clinical Research • As of August 16, 2009 • 10,974 trials IOM Drug Forum Clinical Trials Workshop - R Krall

  17. Ongoing US Clinical Research • As of August 16, 2009 • 10,974 trials • 2,836,948 subjects IOM Drug Forum Clinical Trials Workshop - R Krall

  18. Ongoing US Clinical ResearchInterventions being tested 10,974 Trials 2.8M Subjects IOM Drug Forum Clinical Trials Workshop - R Krall

  19. Ongoing US Clinical ResearchTrials by Phase 10,974 Trials IOM Drug Forum Clinical Trials Workshop - R Krall

  20. Ongoing US Clinical ResearchSubjects by Phase 2.8M Subjects IOM Drug Forum Clinical Trials Workshop - R Krall

  21. Trials by phase for the regulated interventions: drugs, biologics, devices, dietary supplements IOM Drug Forum Clinical Trials Workshop - R Krall

  22. Ongoing US Clinical ResearchRegulated Interventions being tested 8,386 Trials 1.9M Subjects IOM Drug Forum Clinical Trials Workshop - R Krall

  23. Ongoing US Clinical ResearchRegulated Product Trials, by Phase 8,386 Trials IOM Drug Forum Clinical Trials Workshop - R Krall

  24. Ongoing US Clinical ResearchRegulated Product Trials, by Subjects 1.9M Subjects IOM Drug Forum Clinical Trials Workshop - R Krall

  25. Regulated Products, Phase II Trials: Subjects 2606 Trials IOM Drug Forum Clinical Trials Workshop - R Krall

  26. Regulated Products, Phase III Trials: Subjects 1105 Trials IOM Drug Forum Clinical Trials Workshop - R Krall

  27. Regulated Products, Phase IV Trials: Subjects 2283Trials IOM Drug Forum Clinical Trials Workshop - R Krall

  28. Phase II Note: 50 epoch value is 1235 Phase III Phase IV IOM Drug Forum Clinical Trials Workshop - R Krall

  29. What diseases are being studied? IOM Drug Forum Clinical Trials Workshop - R Krall

  30. US Ongoing Clinical Research IOM Drug Forum Clinical Trials Workshop - R Krall

  31. Diabetes Research IOM Drug Forum Clinical Trials Workshop - R Krall

  32. Depression Research IOM Drug Forum Clinical Trials Workshop - R Krall

  33. Cardiovascular Research IOM Drug Forum Clinical Trials Workshop - R Krall

  34. Cancer Research IOM Drug Forum Clinical Trials Workshop - R Krall

  35. Who’s carrying out the research?Where’s the research being done?How effective is it? IOM Drug Forum Clinical Trials Workshop - R Krall

  36. Tufts Center for Study of Drug Development Impact Study • 26,000 FDA registered Investigators – 2007 • 85% of investigators are participating in only 1 trial • 50% filing in one calendar year do not participate in subsequent years IOM Drug Forum Clinical Trials Workshop - R Krall

  37. Tufts Center for Study of Drug Development Impact Study • 14,000 US Investigators • 3.5% annual decline since 2001 • 57% of total investigators • ROW investigators: • 8.5% Central and Eastern Europe • 5.5% Asia • 5.5% Latin America IOM Drug Forum Clinical Trials Workshop - R Krall

  38. Industry sponsored trials – where are they being conducted? • KMR 2006 Data (15 large pharma companies) • 46% of subject visits occurred in US • Per $1M clinical operations expense • 902 patient visits ex-US • 860 patient visits US IOM Drug Forum Clinical Trials Workshop - R Krall

  39. Industry sponsored trials - effectiveness • Pharmaceutical company data • 27% of US investigators fail to enroll any subjects • 19% ROW • 75% of US investigators fail to enroll target number of subjects • ROW not very different • US investigators enroll 4.6 subjects • ROW 7.5 • 90% of all trials extend their enrollment period IOM Drug Forum Clinical Trials Workshop - R Krall

  40. Summary • 10,974 Active Interventional Trials in the US; 2.8M subjects • Drug and Biologics trials: 68% of trials and 57% of subjects • Behavioral trials: 10% of trials and 16% of subjects • For regulated products • Phase IV research accounts for 27% of trials and 25% of subjects • Phase IV research is characterized by many small trials and very few large trials • Almost half of all active interventional trials are cancer trials • More than 10% of all sought subjects are for CV trials • Cancer trials are characterized by small number of subjects per trial, where CV trials seek large numbers of subjects per trial • Most investigators are participating in only a single trial • Only 57% of investigators are from the US, and only 46% of industry sponsored trial patient visits are in the US • Industry trials: • 27% of US investigators fail to enroll any subjects; 75% miss their target • 90% of trials miss their target for completion of subject enrollment IOM Drug Forum Clinical Trials Workshop - R Krall

  41. “Effective” Clinical Research Management • Measure your performance • Finding and retaining subjects • Data Quality • Time • Cost • Subject Experience • Choose your studies carefully IOM Drug Forum Clinical Trials Workshop - R Krall

  42. US Clinical Research 3rd Clinical Research Management Workshop June 21, 2010 Originally presented at the IOM Drug Forum Clinical Trials Workshop, October 7, 2009 Ronald Krall, MD Krallrl@msn.com IOM Drug Forum Clinical Trials Workshop - R Krall

  43. Backups IOM Drug Forum Clinical Trials Workshop - R Krall

  44. Phase I Trials: Subjects IOM Drug Forum Clinical Trials Workshop - R Krall

  45. Phase I Trials: Subjects IOM Drug Forum Clinical Trials Workshop - R Krall

  46. $32.2B IOM Drug Forum Clinical Trials Workshop - R Krall

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