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Subject Injury Issues in Clinical Research

Subject Injury Issues in Clinical Research. Massachusetts Biotechnology Council June 26, 2008. Agenda. Current Law and Guidance An IRB Member’s Perspective A Sponsor’s Perspective Overview of Applicable Insurance Products Davenport Case Study Q&A. What is a Subject Injury.

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Subject Injury Issues in Clinical Research

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  1. Subject Injury Issues in Clinical Research Massachusetts Biotechnology Council June 26, 2008

  2. Agenda • Current Law and Guidance • An IRB Member’s Perspective • A Sponsor’s Perspective • Overview of Applicable Insurance Products • Davenport Case Study • Q&A Nutter McClennen & Fish LLP • www.nutter.com

  3. What is a Subject Injury • Injury caused by participation in the clinical trial • An Adverse Event, a side-effect • Injury from the study drug, device, comparator, procedure required by protocol • Compensation is without fault • It is not - pre-existing condition, natural disease progression, injury from regularly scheduled care, negligence of physician Nutter McClennen & Fish LLP • www.nutter.com

  4. Current US Law • There is no current US Law that requires the Sponsor of a clinical trial to cover medical expenses for a Subject injured in the trial. • There is no current US Law that requires the Sponsor of a clinical trial to carry liability or other insurance. Nutter McClennen & Fish LLP • www.nutter.com

  5. Current US Law • Federal Policy for the Protection of Human Subjects a/k/a The Common Rule 45 CFR Part 46, Subpart A; 45 CFR 46.116(a)(6) • FDA – Protection of Human Subjects 21 CFR Parts 50 and 56; 21 CFR 50.25(6) • Both say - For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained Nutter McClennen & Fish LLP • www.nutter.com

  6. Current Guidance • No standardized forms or compensation plans • IOM’s 2002 recommendations - Responsible Research: A Systems Approach to Protecting Research Participants • See, e.g., ABPI for ex-US standard form for subject compensation Nutter McClennen & Fish LLP • www.nutter.com

  7. Current Guidance • Guideline for Good Clinical Practice of the International Conference on Harmonization - GCP 5.8 “should address” injury compensation and carry insurance “if required by applicable regulatory requirements” • Declaration Helsinki – no requirement for medical expense compensation, requires subjects be “adequately informed” • WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects – does not require injury compensation Nutter McClennen & Fish LLP • www.nutter.com

  8. Injury Provision in Consent Form • At a minimum, should clearly state: • Who pays • For what • Under what conditions • Contact for any questions Nutter McClennen & Fish LLP • www.nutter.com

  9. Sample Consent Clause • Sponsor will provide all reasonable medical treatment necessary for any illness or injury caused by your participation in this research study. No other compensation will be provided for the treatment of medical complications that are part of the natural course of any underlying and/or pre-existing disease process present prior to the receipt of the study product. Other compensation of any type for such things as lost wages, disability, discomfort, pain or suffering to research subjects is not available. You do not give up your rights as a research subject by signing this form. Nutter McClennen & Fish LLP • www.nutter.com

  10. Media references • Steinbrook R, Compensation for injured research subjects, NEJM 2006:354:1871 - 3 • Elliott C, Guinea-pigging, The New Yorker, January 7, 2008:36-41 • Evans D, Smith M, Miami Test Center Lures Poor Immigrants as Human Guinea Pigs, Bloomberg.com, November 2, 2005. Nutter McClennen & Fish LLP • www.nutter.com

  11. Davenport • Summary of case • Wall Street Journal, January 31, 2008, When Drug Trials Go Wrong, Patients Have Little Recourse (Page 1) • Neurology Today, May 15, 2008, Clinical Trial Liability: What If a Patient is Injured? • Panel Discussion Nutter McClennen & Fish LLP • www.nutter.com

  12. Case Summary • Subject, Suzanne Davenport, 71 year old retired teacher • First diagnosed with Parkinson’s 1989 • 2004 disease had advanced somewhat and physicians at UCLA where she got some of her care discussed participation in a clinical trial with her Nutter McClennen & Fish LLP • www.nutter.com

  13. Case Summary • Phase 2 trial - surgery to implant Spheramine into brain with aim of improving motor skills • Prior study involved 6 patients with promising results and no SAEs • Sponsor - Titan Pharmaceuticals in partnership with Berlex, Inc (US arm of Schering AG); Berlex later acquired by Bayer AG Nutter McClennen & Fish LLP • www.nutter.com

  14. Case Summary • UCLA Consent form said: EMERGENCY CARE AND COMPENSTAION FOR INJURY If you are injured as a result of research procedures, you will receive treatment at no cost. The University of California does not provide any other form of compensation. Nutter McClennen & Fish LLP • www.nutter.com

  15. Case Summary • Surgery moved to Tampa General Hospital. Surgeon employed by the University of South Florida (USF) • As part of this change, subject signed another consent form that contained 3 “injury statements” Nutter McClennen & Fish LLP • www.nutter.com

  16. Case Summary • Statement from USF said financial damages would be available in the event of an injury “to the extent the negligent conduct of a University employee caused your injuries” • Statement from Hospital said cost of treatment for injury “may be the responsibility of you or your insurance company” Nutter McClennen & Fish LLP • www.nutter.com

  17. Case Summary • The statement from Berlex (Sponsor) said: • If because of your participation in the study you require additional care that would not ordinarily be necessary for your condition, this will be provided at no additional cost to you. Nutter McClennen & Fish LLP • www.nutter.com

  18. Case Summary • Prior to surgery, Subject could drive, cook and care for herself. • Immediately following surgery, cognitive skills are substantially diminished, no longer able to walk, sit upright and required a diaper • Within a short time she required nursing home care where she remains Nutter McClennen & Fish LLP • www.nutter.com

  19. Case Summary • Subject's treating neurologist believes Study drug caused her decline, and she should have had at least another 10 years of independent living. • Her family became dependent on Medicaid for her care. • Subject’s family attempted to enforce the consent form promise, was sent by UCLA to Titan and by Titan to Berlex. Titan and Berlex had both clinical and legal departments involved. Nutter McClennen & Fish LLP • www.nutter.com

  20. Case Summary • Berlex raised concerns about not compromising Medicaid eligibility. Suggested a lump-sum payout might be preferable to simply covering the monthly bills. And suggested since Subject would have eventually needed nursing home care, Sponsor should be liable for only the extra care required as a direct result of the trial. Nutter McClennen & Fish LLP • www.nutter.com

  21. Case Summary • 2007 family hired an attorney and sued for the cost of modifying their home and caring for Davenport at home, as well as damages, medical expenses and attorneys fees, more than $5 million. • May 2008 the case settled. Nutter McClennen & Fish LLP • www.nutter.com

  22. Case Discussion • Is this the “right” course of action? • Should the subject have expected to sue? • What would the IRB have expected? • Insurer’s perspective? • More complicated because of (inevitable?) long term care Nutter McClennen & Fish LLP • www.nutter.com

  23. Some Key Sponsor Take-Aways • Talk to your insurer • Talk to your research partners • Make sure the Consent Form says what you mean and is consistent with the CTA • Page 1 of the WSJ Test Nutter McClennen & Fish LLP • www.nutter.com

  24. Resources • Declaration of Helsinki http://www.wma.net/e/ethicsunit/helsinki.htm • Association of American Medical Colleges January 2004 publication “Clinical Trial Contracts” – www.aamc.org • http://www.guineapigzero.com Nutter McClennen & Fish LLP • www.nutter.com

  25. Resources • ICH – GCP - http://www.wma.net/e/ethicsunit/helsinki.htm • Office for Human Research Protections - http://www.hhs.gov/ohrp/ • Association of the British Pharmaceutical Industry - http://www.abpi.org.uk • CIOMS/WHO – International Ethical Guidelineshttp://www.cioms.ch/frame_guidelines_nov_2002.htm Nutter McClennen & Fish LLP • www.nutter.com

  26. Questions • Maria D. Buckley • Nutter, McClennen & Fish, LLP617-439-2709mbuckley@nutter.com • Thank you. Nutter McClennen & Fish LLP • www.nutter.com

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