FDA s Guidance on Using a Centralized IRB Review Process in Multicenter Clinical Trials

Transcription

1 FDA s Guidance on Using a Centralized IRB Review Process in Multicenter Clinical Trials Bridget Foltz Office of Good Clinical Practice Office of Medical Products and Tobacco Food and Drug Administration November 14, 2017

2 FDA s Regulations and Guidance Purpose of the regulations: to explicitly reduce duplicative review of multiinstitutional studies to assure IRBs that FDA will accept reasonable methods of joint review Guidance: Using a Centralized IRB Review Process in Multicenter Clinical Trials, issued in March,

3 IRB Regulations Cooperative Research In complying with these regulations, institutions involved in multi institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort. 21 CFR

4 Centralized IRB Review Guidance Overarching Goals Describes roles of participants in a centralized IRB review process Offers guidance on how a centralized IRB review process might consider the concerns and attitudes of the various participating communities Recommends documenting agreements between the local and central IRB to establish respective responsibilities 4

5 Centralized IRB Review Guidance Overarching Goals Recommends IRBs have procedures for implementing a centralized review process Makes recommendations for central IRB s documentation of its reviews of studies at clinical trial sites not affiliated with an IRB 5

6 Centralized IRB Review Guidance Scope Section 520(g)(3) of FD&C Act required review by a local institutional review committee for device clinical investigations Guidance only applies to FDA regulated studies of investigational drugs and biologics 6

7 Centralized IRB Review Guidance Flexibility Because the goal of the centralized process is to increase efficiency and decrease duplicative efforts that do not contribute to meaningful human subject protection, it will usually be preferable that a central IRB take responsibility for all aspects of IRB review at each site participating in the centralized review process. Other approaches may be appropriate as well. For example, an institution may permit a central IRB to be entirely responsible for initial and continuing review of a study, or apportion IRB review responsibilities between the central IRB and its own IRB. 7

8 Centralized IRB Review Guidance Specifics Roles in Ensuring IRB Review Institution May use joint review, rely on the review of another IRB, or establish other arrangements aimed at reducing duplicative efforts Institution s IRB May serve as a central IRB, rely on another IRB review, or review on its own Sponsor Obtains commitment from investigator that part 56 requirements are met and may initiate plans for centralized IRB review process 8

9 Investigator Roles in Ensuring IRB Review Responsible for ensuring initial/continuing review by qualified IRB Central IRB IRB that conducts reviews on behalf of all study sites Central IRB should reach agreement with individual institutions and institution s IRBs about how to apportion review responsibilities between local IRBs and Central IRB 9

10 Addressing Local Aspects of IRB Review 21 CFR (a) IRB membership Sufficient experience, expertise and diversity Provide meaningful consideration of local factors Consideration of ethical standards of local community Provision of relevant local information to central IRB in writing Participation of consultants or local institutional IRB members during Central IRB deliberations Limited review of institutional IRB to cover local concerns 10

11 IRB Records Documenting Agreements 21 CFR (a) Requires preparation and maintenance of adequate documentation of IRB activities Documentation of agreement to participate in a centralized IRB review process Report agreement to investigator and institution Agreement should delineate specific responsibilities of central IRB and institutional IRB 11

12 IRB Records Documenting Procedures 21 CFR (a) and (a)(6) Requires IRBs to follow written procedures Written procedures in place for centralized IRB process should address: How the institution s IRB determines the Central IRB is qualified to review the research How Central IRB will communicate with other institutions, IRB s and investigators regarding its review How Central IRB will ensure consideration of local factors How Central IRB will assess ability of a remote site to participate in a study Each participating IRB must have procedures in place 12

13 Using a Central IRB at Unaffiliated Sites Central IRB should document in meeting minutes or other records how local factors were considered for the study Document its action agreeing to conduct IRB review Have written procedures for conducting initial and continuing review at remote sites 13

14 Examples of Cooperative IRB Review Models Trial in which multiple sites rely on a central IRB Central IRB formed to review multicenter trials in a therapeutic area E.g., NCI central IRB and multisite cancer studies Regional and nonregional cooperatives Academic medical centers acceptance of reviews by IRBs at other centers when participating in same trial 14

15 What additional guidance would be helpful? Section 3056 of the 21 st Century Cures Act modified statute to remove requirement for review by local institutional review committee. Regulation and guidance can now include device studies FDA is interested in your input as we revise our regulations and guidance 15