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Tuncay Göksel, MD Ege University Medical School Dept. of Pulmonary Medicine

Phase II and III drug trials in pulmonary diseases. Tuncay Göksel, MD Ege University Medical School Dept. of Pulmonary Medicine. Share of gross domestic product to R&D in the World. Israel: 4.71 % (leader of the World) The average of the OECD: 2.25% Turkey < 1.5%.

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Tuncay Göksel, MD Ege University Medical School Dept. of Pulmonary Medicine

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  1. Phase II and III drug trials in pulmonary diseases Tuncay Göksel, MD Ege University Medical School Dept.of Pulmonary Medicine

  2. Share of gross domestic product to R&D in the World • Israel: 4.71% (leader of the World) • The average of the OECD: 2.25% • Turkey < 1.5%

  3. Areas of R&D in the World

  4. Contribution of new therapy methods to life expectancy • Expected average survival • Beginning of 20.century: 47 years • Today: 76 years • Every 5 year, it has increased 1 year since 1965

  5. Drugs in developing process More than 1000 drugs that developing or waiting for approval • 400 cancer drugs • 200 pediatric drugs • 120 cardiac drugs • 98 AIDS drugs • 135 Neurological drugs • 24 Alzheimer drugs • 23 Diabetic drugs • 22 Romatoid Artrit drugs • 17 Parkinson drugs • 15 Osteoporosis drugs • 44 respiratory drugs • 20 depression drugs • 16 skin diseases drugs • 14 urinary drugs • 19 GI drugs • Other

  6. Phase I study • The first step in humans • Aim • Evaluating a drug’s safety profile (the safe dosage range) • To determine the Maximum Tolerable Dose (MTD) • Determining how the drug absorbed and broken down by the body • The best way to give the drug to a patient(orally, IV etc.) • For MTD • Fibonacci design:different dosages in few patients • Simon design:increasing doses in a patient • Except cancer drugs, Phase 1 clinical trials in healthy individuals • Study population: 20 100 patients

  7. Phase II study • Aim: • To investigate efficacy and safety of therapeutic dose limits of drug in targeted disease or condition • The dosage of the new drug: usually 75-90% of MTD • Several different doses of the drug may be compared • Study population: 100-200 patients

  8. Phase III study • Phase III study is planned after a drug has been shown to have positive results in small groups (phase II) • Aim • To compare the study drug with inactive placebo and/or another approved medication • To confirm efficacy and identify adverse events from long-term use • The last study before approval • Study population: 600-1000 patients

  9. Phase IV study • “Post-marketing" trials, after Phase III study • Aim • To compare approved drugs or treatments • To look for adverse events in larger populations over longer periods of time

  10. Drug developing period . . .

  11. Costs during drug R&D

  12. The budget of clinical drug trial in the world • Drug R&D  30 billion $ • ~40% of R&D  Clinical trial • Clinical trial  12.5 billion $

  13. Industry sponsored clinical trial protocolsOct 2005 – Sept 2007 / www.ClinicalTrials.gov

  14. Industry sponsored clinical trial / study sitesOct 2005 – Sept 2007 /www.ClinicalTrials.gov

  15. Clinicaltrials in Turkey2006  2009

  16. Total clinical trial 71,097 in 165 countries Turkey: 489 (0.7%)

  17. Phase I: 10896 studies Turkey: 5 (0.005%)

  18. Phase II: 20301 studies Turkey: 72 (0.4%)

  19. Phase III: 13950 studies Turkey: 267 (1.9%)

  20. Phase II+III (II-III): 32621 studies Turkey: 326 (1%)

  21. Phase IV: 8131 studies Turkey: 97 (1.2%)

  22. All clinical trials in Turkey: 489 • Open studies: 173 • Phase I : 2 • Phase II : 27 • Phase III : 97 • Phase IV : 24

  23. All studies related to respiratory diseases 6816 (map)Open studies: 2535 All studies related to respiratory diseases in Turkey: 68 Open studies: 22

  24. Phase I studies related to respiratory diseases: 854 Turkey: 0

  25. Phase II studies related to respiratory diseases: 2089 Turkey: 9 (0.4%)

  26. Phase III studies related to respiratory diseases: 1501 Turkey: 44 (2.9%)

  27. Phase II-III studies related to respiratory diseases:3451

  28. Phase II-III studies related to respiratory diseases in Turkey: 53

  29. Written regulation about clinical trials Turkish Official Bulletin 23 Dec 2008, Number: 27089 Official regulation

  30. Problems in clinical trial in Turkey • Multi-centric studies • Organizer?/ Partner? / Site? • Education of trial staff • There is no a lot of educated people • Bureaucracy • Ethical committee • Problems related to regulations • Budget and accountancy • “Test subject” syndrome • Public not informed • Negative approach in press

  31. Education /team collaboration • Educated investigator • Primary investigator • Assistant investigator • Site coordinator • Research nurse • Team should take GCP • Team working is very important • All clinics in hospital should be motivated • Biochemistry • Radiology • Nuclear Medicine • Pathology • Microbiology • Other

  32. Bureaucracy • New regulation change Ethical Committee System (30.6.09) • Regional Ethical Committee • Ministry Ethical Committee will perform only audit • Dedicated offices should be in centers • The should solve bureaucratically problems • It is very important jab • University hospitals should determine this as a science politics

  33. Good planning for patients number • Centers can account how many patients enter the study • They comply the plan

  34. Problems related to budget and accountancy • High tax in investigator fee (average 70%) • University deduction: 45% • 5% General tax • 35% Center share • 5% University investigation share • Individual tax (20-35%) • No fee for center personnel, nurse and assistants (due to regulations)

  35. Contribution of clinical trials to multidisciplinary working (Ege Thoracic Oncology experiences) • Completed 12 Phase III and one Phase II studies • New studies • 3 Phase III (April) • 1 Phase II (May) • GCP routine work • Registration and follow up  high standard • Approach between different clinics  high standard • Quality of treatment and management of adverse event increased

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