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NIH’s Efforts to Promote the Harmonization of Clinical Research Policies

NIH’s Efforts to Promote the Harmonization of Clinical Research Policies Secretary’s Advisory Committee on Human Research Protections October 27, 2009. Overview of Presentation. Clinical Research Policy Analysis and Coordination (CRpac) Program Background Key Initiatives

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NIH’s Efforts to Promote the Harmonization of Clinical Research Policies

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  1. NIH’s Efforts to Promote the Harmonization of Clinical Research Policies Secretary’s Advisory Committee on Human Research Protections October 27, 2009

  2. Overview of Presentation • Clinical Research Policy Analysis and Coordination (CRpac) Program • Background • Key Initiatives • Federal Adverse Event Task Force • Optimizing IRB Review • Informed Consent • International • Privacy • Specimens and Data

  3. CRpac Program • Aims • Promote clear, effective, and coordinated policies and regulations for the conduct and oversight of clinical research • Maintain the integrity and enhance the effectiveness of federal and institutional systems of oversight • Methods • Conduct technical and policy analysis • Providing advice and recommendations • Build partnerships and develop new mechanisms of interaction • Develop tools and resources • Formally established as an OD program in 2004

  4. CRpac Priority Issues • Adverse Event Reporting • Clinical Trial Issues • Optimizing IRB Review • Informed Consent • Privacy and Confidentiality • Research Using Specimens and Data • Application of Human Subjects Regulations

  5. CRpac Outreach and Engagement • Formal Liaison • HHS Office for Human Research Protections (OHRP) • Food and Drug Administration (FDA) • Designated Agency Representative • Secretary’s Advisory Committee on Human Research Protections • White House National Science and Technology Council, Committee on Science, Human Subjects Research Sub-Committee (HSRS) • Committee Leadership • Trans NIH Bioethics Committee • Trans-HHS Taskforce on Harmonization of Ethical and Legal Policies Related to the Use of Human Specimens and Data in Research (HELPS) • Federal Adverse Event Task Force

  6. CRpac Outreach and Engagement • International Organizations • World Health Organization (WHO) • European Commission • Council of Europe • Organization for Economic Cooperation and Development (OECD) • Academic, Professional and Industry Associations • Public Responsibility in Medicine and Research (PRIM&R) • American Society for Bioethics and the Humanities (ASPH) • Association of American Medical Colleges (AAMC) • International Society for Biological and Environmental Repositories • Institute of Medicine Forum on Drug Discovery, Development and Translation • FDA-Duke Clinical Trials Transformation Initiative (CTTI) • Society for Clinical Trials • American Medical Association (AMA) and World Medical Association (WMA) • Biotechnology Industry Organization (BIO) • Pharmaceutical Research and Manufactures Association

  7. Adverse Event Reporting Issues • Divergent federal reporting policies creates confusion, non-compliance, increased costs • Poor quality of information, no standards, incomplete reports • Deluge of AERs that cannot be interpreted in multi-site trials • Safety implications

  8. Harmonizing and Streamlining Adverse Event Reporting • Major trans-Federal effort to enhance consistency of Federal policies and approaches • Federal Adverse Event Task Force (FAET) • FDA • OHRP • CDC • DOD • DVA • NIH (Chair)

  9. FAET Objectives • Develop best practices blueprint for reporting, analysis, and application of safety information • One AE report that PIs can send to multiple agencies – Basal Adverse Event Report (BAER) • Optimize communication of analyzed safety information

  10. Basal Adverse Event Report (BAER) Overview • Scope • Draws upon a single baseline set of core medical information adopted by all FAET agencies to report • Encompasses all forms of clinical research • Safety information to multiple agencies, IRBs, and DSMBs • Unanticipated problems to OHRP • Pre and Post-market adverse events to FDA • Incorporation of HHS standards for data transmission and vocabularies • Aims • Offer utility for reporting at local and federal level • Offer standards for full spectrum of clinical research

  11. Implementation of Harmonized Adverse Event Reporting • Harmonized AE reporting dataset across FAET members • Benefits to clinical research community will be seen as practical implementation steps continue • Endorsed by: • Secretary’s Advisory Committee on Human Research Protections

  12. Goal of the Federal-Wide Safety Reporting Portal • Development of a user- friendly, standardized electronic submission system to report an adverse event or unanticipated problem to the federal government by: • Investigators • Sponsors • Manufacturers • Physicians • Consumers Human subjects research reporting, Pre-market reporting Post-market reporting

  13. Portal Features • Single site for the collection and transmission of adverse events and unanticipated problems • Encompasses pre- and post- market data • Single data entry, multiple uses • Relevant AE data may be submitted to multiple agencies • Interactive help system for reporters • Decision-tree based logic (wizard) to assist reporters in identifying appropriate agencies and data sets for submission • Incorporate appropriate data standards • Will utilize HL7 transmission message for routing information to Federal agencies • First practical implementation of the BAER • Will establish feasibility of the BAER for data collection

  14. Current Status of Portal:NIH/FDA Prototype • FDA and NIH established collaboration to develop an initial portal prototype to test feasibility • 1st release of the Portal in Winter 2009 • FDA products in the first release will include selected reporting on animal drugs, animal foods, and human foods • NIH feasibility testing on data exchange using gene transfer research adverse event report (GeMCRIS)

  15. Next Steps for Portal Development • Complete Portal system requirements and design • Launch Release 1 in Winter 2009/10 • Evaluation of criteria/performance measures • Begin preparation for Release 2 in early summer 2010 • Extend the Portal to incorporate other agencies

  16. Optimizing IRB Review: Principles and Potential Models • Historically IRBs • Conceptualized at a time when primarily large academic institutions conducted human research • Established as a local, institutional body • Obligated to consider local context • Single-site research predominated • Evolving research landscape • Research increasingly a collaborative enterprise • Growing prominence of multi-site trials • Central and other models of IRB review increasingly attractive • Efficiency • Consistency • Rigor

  17. National Conference November 20-21, 2006 Sponsors NIH CRpac, OHRP, VA, DoD, AAMC, ASCO, PRIM&R, AAU, COGR, COSSA, NACUA Explored: Shared responsibility between institutions and independent review boards Characteristics of alternative IRBs and impact on quality of review Liability issues Economic considerations Optimizing IRB Review: Need for National Dialogue

  18. Optimizing IRB Review: An Evolving Research Landscape • IRB Models • Facilitated review (e.g., NCI CIRB) • CTSAs • Reciprocal IRB review (e.g., MACRO) • Consortia (e.g., BRANY) • Independent (e.g., Western, Chesapeake) • Institutional Challenges to Implementing Alternative IRBs1: • Liability concerns • Desire for local control • Misunderstanding of federal policies 1Academic Medicine, July 2004

  19. IRB Models of Review

  20. Current Efforts • Points to Consider in Selecting Models of Review by Institutional Review Boards • Under development • NIH Request for Information • Collaboration with CTSA program • Assess needs & programs for planning & monitoring multisite studies • Pending

  21. Informed Consent • Processes and expectations have become increasingly more complex • Esp. for certain areas of research (hi-tech, hi-risk) • Tools and resources needed to optimize the effectiveness and value of the informed consent process • Pilot project developed with OHRP, FDA, NIH • Informed consent for gene transfer research • http://www4.od.nih.gov/oba/rac/ic/

  22. Informed Consent • Points to Consider:Research Involving Individuals with Questionable Capacity to Consent • Points to Consideron developing informed consent forms and conducting informed consent • Alternatives to participation • Assent • Comprehensibility • Privacy and Confidentially • Conflict of Interest

  23. International Issues:HHS Comments on Revisions to the Declaration of Helsinki

  24. International Issues: EU Clinical Trial Directive • EU CTD Implemented by Member States (MS) May 1, 2004 • Applies to interventional trials • Concern the directive missed facilitation & harmonization goals • NIH is documenting its experiences in partnering with EU MS on multisite clinical trials • Significant complications with indemnity, legal representative of the sponsor, single sponsor & GMP/QP, definitional problems (IMP and non-interventional)

  25. Is the HIPAA Privacy Rule adversely affecting research? Examples: Multi-site research Harmonization issues NIH Funded IOM Study: Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research Addressed the need for more systematic information regarding the impact of the Rule Calls for: Bold new approach to privacy protections in research Changes in Rule and additional guidance Privacy Issues in Research

  26. Research Involving Specimens and Data Repositories • Disharmony in regulations and policies • Creates barriers to biobanking and sharing data • Guidance needed to clarify complex issues • e.g., ownership, intellectual property, return of research results • Public Responsibility in Medicine & Research White Paper • Identified barriers and approaches for overcoming them • CRpac supported • PRIM&R White Paper:Report of the Public Responsibility in Medicine and Research (PRIM&R) Human Tissue/Specimen Banking Working Group

  27. Research Involving Specimens and Data: Promoting Harmonization at Several Levels • NIH • Developing NIH-wide guidelines on ethical issues related to the collection, storage, use and sharing of specimens and data in research • HHS • Promoting harmonization of policies across HHS federal regulatory and funding agencies • FDA Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable (April 25, 2006)

  28. Trans-HHS HELPS* Taskforce • Goals • AHRQ, ASPE, CDC, FDA, OCR, OHRP, ONC, NIH (Chair) • Identified inconsistencies in regulations and policies and areas that may benefit from additional policy guidance and/or educational materials • Developing educational document on key terminology * Trans-HHS Taskforce on Harmonization of Ethical and Legal Policies Related to the Use of Human Specimens and Data in Research

  29. Web-accessible Tools and Resources • Compendium of NIH Resources on Informed Consent • Clinical Trial Monitoring Guidelines • IRB Models Workshop & Conference Proceedings • Bioethics Resources on the Web • PRIM&R Working Group White Paper on Human Specimen/Tissue Banking

  30. NIH Clinical Research Policy Analysis and Coordination Program Office of Biotechnology Activities Office of Science Policy Office of the Director, NIH 6705 Rockledge Drive, Suite 750 Bethesda, MD 20892 301-496-9838 301-496-9839 (fax) Email: CRpac@od.nih.gov http://crpac.od.nih.gov/

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