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THE UNIQUE ROLES OF IRB IN MEDICAL DEVICE CLINICALL TRIAL

THE UNIQUE ROLES OF IRB IN MEDICAL DEVICE CLINICALL TRIAL. Chiu Lin, Ph.D. CITI, May, 2009. The World of Medical Device Industry. Venture Oriented Diverse > 20,000 firms world wide Produce > 80,000 brand products Rapidly Expanding Becoming very innovative and high-tech.

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THE UNIQUE ROLES OF IRB IN MEDICAL DEVICE CLINICALL TRIAL

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  1. THE UNIQUE ROLES OF IRB IN MEDICAL DEVICE CLINICALL TRIAL Chiu Lin, Ph.D. CITI, May, 2009

  2. The World of Medical Device Industry • Venture Oriented • Diverse • > 20,000 firms world wide • Produce > 80,000 brand products • Rapidly Expanding • Becoming very innovative and high-tech

  3. Medical Device Industry Exponential Growth Number of Manufacturers by Year Dun & Bradstreet Medical Device Firm Data

  4. 4

  5. DEVICES ARE NOT DRUGS • DRUGS ARE DISCOVERED • DEVICES ARE DESIGNED

  6. DEVICES (IDE)( ̴̴ 20% clinical trials) Effectiveness and/or safety pivotal trial (one phase) DRUGS AND BIOLOGICS (100% clinical trials) (IND) Dose limiting toxicity (Phase I) Safety and efficacy (Phase II & Phase III) Development of Products -Clinical Investigations

  7. The complexity and need for clinical data is growing… Embolic protection devices Daily wear contact lenses Vascular anastomosis devices for CABG CPAP devices for apnea … requiring more in-depth assessment of safety and effectiveness……. Combination product Glaucoma shunts Image-guided bronchoscopes

  8. Perspectives of Device Clinical Trials – Compared to Drugs • Devices vary greatly on type, intended use population, and risk posed • FDA device regulation recognizes these differences by classifying devices into 3 classes: Class I (low risk), Class II (intermediate risk), and Class III (high risk) • FDA does not automatically require clinical trials as part of its approval process for all devices (only about 20% devices require clinical trials)

  9. Premarket Submission Requirements of Medical Devices • Premarket Notification [510(k)] –Class I & Class II • Premarket Approval (PMA) – Class III

  10. PREMARKET NOTIFICATION 510(K) Data to demonstrate the new device is as safe and effective (substantially equivalent, SE) as a legally market (predicate) device Only in few cases, a clinical data is needed to support SE determination.

  11. PREMARKET APPROVAL (PMA) • The most stringent marketing application • PMA must contain sufficient information to reasonably assure the safety and effectiveness of the proposed device. • Valid scientific evidence must be provided to demonstrate that the device is safe and effective for its intended use.

  12. Valid Scientific Evidence(21 CFR 860.7) • Well-controlled clinical investigation • Partially controlled clinical studies • Studies and objective trials without matched control

  13. Regulation of Medical Device Clinical Investigation • 21 CFR Part 812 - Investigational Device Exemption, IDE (IND – 21 CFR Part 312) • 21 CFR Part 50 - Informed consent – drugs, devices, and biologics • 21 CFR Part 56 - Institutional Review Boards (IRB) – drugs, devices, and biologics

  14. Clinical Investigations Subject to IDE Regulation • To support marketing application [PMA, or 510(k)] • Collection of safety and effectiveness information for unapproved device • Sponsor-investigator studies

  15. Clinical Investigation Under IDE • To determine safety and effectiveness of an investigational device • Nophases in clinical investigation • Distinction between significant risk (SR) devices and non-significant risk (NSR) devices in approval process • Different approval procedures for SR and NSR studies

  16. Significant Risk (SR) Investigation • A study that presents a potential for serious risk to the health, safety, or welfare of a subject • Require FDA and IRB approval before clinical investigation can begin

  17. Examples of SR Devices • Cardiac catheters • Surgical tissue adhesives • Vascular and arterial graft protheses • Dental endosseous implants • Cochlear implants • Implantable infusion pumps • Implantable pacemaker

  18. Examples of NSR Devices (Require only IRB approval for investigation) • Bio-stimulation lasers for treatment of pain • Daily wear contact lenses • Glucose monitor • Blood pressure monitor • Magnetic resonance imaging (MRI) • Pulse oximeter • Ob/Gyn diagnostic ultrasound

  19. Approving Clinical Investigation of Medical Devices by IRB(21 CFR 812 Subpart D – IDE Regulation)

  20. IRB Review and Approval • § 812.60 – IRB composition, duties, and function • An IRB reviewing and approving investigation shall comply with requirements of Part 56 in all respects, including its composition, duties, and function

  21. IRB Review and Approval • § 812.62 – IRB Approval • An IRB shall review and have authority to approve, require modifications, or disapprove all investigations under IDE. • If FDA finds that an IRB’s review is inadequate, a sponsor should submit an IDE application to FDA.

  22. IRB Review and Approval • § 812.64 – IRB’s Continuing Review • The IRB shall conduct its continuing review of an investigation in accordance with Part 56.

  23. Determination of SR/NSR Study(21 CFR 812.66) • Sponsor presents protocol to IRB and a statement why investigation does not pose significant risk (NSR study) • If IRB agrees the study is NSR & approves the study, then, no formal IDE submission for FDA approval is needed. Investigation can begin (Abbreviated IDE requirements). • If IRB disagrees, then, submit IDE application to FDA for approval (SR Investigation with full requirements)

  24. Abbreviated IDE • No formal FDA IDE approval is needed • IRB is required to meet all aspects of: • 21 CFR Part 50 (protection of human subjects) – Informed consent • 21 CFR Part 56 (IRB) • Labeling requirements

  25. Comparison Between Device and Drug/Biologics Trials

  26. Regulatory Distinctions • Device Classification – risk based • Class I • Class II • Class III • Drug and Biologics • All high risk • No Class I, II, and III classification

  27. Regulatory Distinctions * Devices: “Investigator agreement” generated by the sponsor [per 21 CFR 812.43(c)] * Drugs: “Statement of Investigator” - Form 1572

  28. Regulatory Distinctions Adverse Events • Devices: investigators shall submit the adverse effect report to the sponsorand IRB [21 CFR 812.150(a)(1)] • Drugs/Biologics: investigators shall submit the adverse effect report to the sponsor [21 CFR 312.64(b)]

  29. Regulatory Distinctions • Device – Significant vs. non-significant risk trials • Drug – All significant risks

  30. Research Distinctions • Device Studies (vs. drug trials) • Small subject population (mostly 100s) • One phase trial • Blinding study is not common • “Controls” vary • Can not do placebo • Sham, active, historical controls are common • CI training is critical (Human Factors) • IRBs play critical role

  31. Regulatory Similarities • 21 CFR 50: Informed consent • 21 CFR 54: Financial Disclosure of clinical investigator • 21 CFR 56: IRB

  32. Regulatory Similarities • FDA approval required • IDE or IND • FDA regulations specify sponsor and clinical investigator responsibilities • 21 CFR 812 and 21 CFR 312

  33. CONCLUSION • The role of IRB in approving medical device clinical trial is identical to approving drug investigation • Additional role in medical device trial is the differentiation of SR and NSR investigation

  34. THANK YOU FOR YOUR ATTENTION !!Question ?

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