9/23/2011 REB REB Harmonization An idea whose time has come? EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 Objectives To provide insight into reasons for the current focus on harmonization of ethics review in Canada harmonization of ethics review in Canada To provide historical perspective on past efforts To further understanding of the meaning of harmonization of REB review To promote an understanding of current initiatives in p g North America re: REB harmonization To share views on impact of current & future efforts EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 1
9/23/2011 Overview Harmonization – why now? Past efforts at ethics governance reform Past efforts at ethics governance reform Impetus for change Current initiatives Prognostication EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 Canadian Past efforts • Governance of Research – Chaiton Report – Chaiton Report – Law Society Report – PRE Research Governance Initiative – AB College of Physicians & Surgeons – FRSQ/Article 21 – NCEHR Task Force on Accreditation • 2 reports • Standard sub-committee – Expert Committee on HRPP in Canada EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 2
9/23/2011 Impetus for Change Canada ’ s deteriorating CT position 20% decline in new trial CTAs 20% decline in new trial CTAs Losing ≈ 12% p.a. Global ranking has dropped from 2 nd to 3 rd /4 th EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 Where are the CTs going? Source: ClinicalTrials.gov, 2011 EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 3
9/23/2011 International distribution of studies for 1 big pharma co. - disproportionate share to our market size? 21/09/2011v2.2 EHIL Jack Corman IRB SERVICES ‘ NE Asia is … becoming the most competitive region for industry ‐ sponsored clinical trials, owing to its population size, financial attractiveness & good track records. … this development will lead all 4 countries in NE Asia to become the most important industry ‐ sponsored emerging clinical trial region. There are …signs that the industry is … decreasing its clinical research development program activities in the established regions of North America & Europe & also in some emerging regions i e Latin America Africa and some emerging regions, i.e. Latin America, Africa and South East Asia including India. …. the winner will be China, Japan, Taiwan or South Korea... ’ CT Magnifier May 2011 EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 4
9/23/2011 How is the US Responding? EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 CTTI : ‘ Increasingly clinical trials are being conducted outside the US. The reasons behind this shift need to be understood so that US patients can continue to be represented in international clinical trials. Reasonable #s of US patients being included in trials is critically patients being included in trials is critically important to address the appropriate use of products by US citizens. [Therefore], the FDA ’ s Office of Critical Path Programs & Duke joined together as founding members of a PPP, the Clinical Trials Transformation Initiative (CTTI) Transformation Initiative (CTTI). CTTI brings CTTI brings together all interested stakeholders to identify practices that through broad adoption [to] increase quality & efficiency of CTs . ’ EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 5
9/23/2011 CTTI = Clinical Trials Transformation Initiative Jan. 2011 “ Background The willingness of institutions to defer full IRB review to a central IRB in defer full IRB review to a central IRB in multicenter trials continues to vary despite a 2006 Food and Drug Administration guidance recommending this approach. It is not yet clear what effect may result from a more recent endorsement of the use of central IRBs in multicenter trials by the U.S. Office for Human Research Protections . 1 ” EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 US Responding by: CTTI Harmonization of FDA/DHHS regs & guidance Attempts to simplify rules/regs for IRBs E.g., new guidance on unanticipated problem reporting Promotion of central models of ethical review Increasing use of private sector central IRBs Stepped up regulatory agency activity Growing importance of accreditation EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 6
9/23/2011 Further US response: HHS ANPRM 1) Revise existing risk-based framework to more accurately calibrate the level ofreview to level of risk. calibrate the level ofreview to level of risk. 2) Using a single IRB review for all domestic sites of multi- site studies. 3) Updating forms & processes for informed consent. 4) Establishing mandatory data security & information ) g y y protection standards for all studies involving identifiable or potentially identifiable data. EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 ANPRM (cont.) 5) Implementing systematic approach to data collection and analysis of data on unanticipated problems & AE’s and analysis of data on unanticipated problems & AE s across all trials to harmonize the definitions and reporting requirements & to make the collection of data more efficient. 6) Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding f from the Common Rule agencies. th C R l i 7) Providing uniform guidance on federal regulations. EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 7
9/23/2011 Why Not Central Review: Five key challenges (ASCO 2005) assurance of review quality; sensitivity to local context; liability; control and accountability (incl. education of researchers & monitoring); and loss of resources. l f EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 What is Harmonization? . Harmonization does not always mean Central Review Central review most efficient Other models possible, e.g., Collaborative review Mutual Recognition “ Reciprocal review ” Specialized REBs Regional/National REBs Experts Committee recommendation: Mixed REB model, no exclusion ( ‘ big tent ’ ) New agency to cover Policy, Education & PEERH Accreditation EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 8
9/23/2011 Changing OHRP Perspective on Harmonized/Central Review The Paradoxical Problem with Multiple-IRB Review Jerry Menikoff, M.D. J.D. NEJMed 2010; 363:1591-1593 Oct 21, 2010 The federal system for protecting research subjects was designed decades ago, when most research studies took place at [one] institution. These days, if a study is conducted at multiple sites, an ethics review by an [IRB] may be repeated many times. This practice has b been criticized for both wasting resources and iti i d f b th ti d leading to inappropriate delays in the conduct of research. EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 Changing Canadian Perspective: “Do It Once & Do It Well” ‘ ...simple calculation suggests [for] a 20-centre trial, some 300–500 person-hours in total may , p y be required of the parties involved in the ethics review process. Given this significant opportunity cost, one would hope to find clear evidence that such a labour-intensive process protects patients effectively. Yet no such data exist…. i Research ethics review: Do it once and do it well Paul Hébert, MD MHSc and Raphael Saginur, MD, CMAJ March 17, 2009; 180 (6). EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 9
9/23/2011 Canadian Developments TCPS second edition REB/IRB Standards Provincial activities 21/09/2011v2.2 EHIL Jack Corman IRB SERVICES Canadian Response EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 10
9/23/2011 TCPS2 Still mainly focused on 1 institution/1 REB, but recognizes alternative ethics review recognizes alternative ethics review mechanisms for multicentre studies Clarifies potential for collaborative, even out- sourced REB reviews by institutions Can be clearer on ways/means for Can be clearer on ways/means for collaborative activities b/n & among REBs to occur EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 REB Accreditation Canada Gazette II 2001-06-20, RIAS: “At the present time,there is no accreditation system in Canada for REBs. This situation is being reviewed by Health Canada in conjunction with the Canadian Institutes of Health Research (CIHR), the National Council on Ethics in Human Research (NCEHR) and other stakeholders in the Canadian clinical research community” Canadian clinical research community EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 11
9/23/2011 Case for Accreditation Foundational for MRA, especially in absence of HC authority over REB operations/no verification authority over REB operations/no verification No accreditation without standards “Standard” is technical EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 REB Standard: An Accreditation Necessity CGSB Committee to set Standards for REBs reviewing biomedical research – established 4 years ago, work is ongoing Struck to set a voluntary standard for REBs that review biomedical research regulated by HC REBs are outside HC inspectorate mandate National Standard of Canada is something entities could be held to E.g., CSA electrical, helmets, etc. CGSB Standard voted on recently, work still underway Assuming a standard is approved by the Committee, need to test uptake & adherence to the standard EHIL Jack Corman IRB SERVICES 21/09/2011v2.2 12
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