Multi-Arm Multi-Stage Randomised Controlled Trials Update

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This update discusses multi-arm, multi-stage randomised controlled trials with stopping boundaries for efficacy and lack-of-benefit. It covers the design extensions, benefits, software tools available, and operating characteristics of MAMS trials. Examples like the STAMPEDE trial are included, along with a brief history of trials and considerations for conducting MAMS studies.

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Release Updates 4.1 Recap 4.2 and 5.0 Plans 1

4.1 Release Recap NIEM 4.1 released this summer (July) Domains with new or updated content: Biometrics Emergency Management Human Services Justice Military Operations Core Supplement 4.0.1 GENC update Tools updated: Movement Schema Subset Generator Tool (SSGT) Migration Tool https://github.com/NIEM/NIEM-Releases 2

4.1 Release Property Stats 3

4.2 Release Plans Current status: Content preparation by domains / NIEM community Minor release overview: Domains may update content as needed Core and its imports are locked until the next major release (5.0) Core Supplements may be published as an interim solution Changes go into a new, separate namespace Architecture is locked Only additive changes that do not affect 4.0-based schemas permitted https://github.com/NIEM/NIEM-Releases/wiki/Upcoming-Release 4

4.2 Release Projected Schedule and Changes Projected schedule: Alpha 1 Beta 1 RC 1 Release January 2019 March 2019 May 2019 Summer 2019 Expected changes: Biometrics update Emergency Management update MilOps update Justice code table updates International Tiger Team updates Harmonization and issue resolutions New Census domain (?) Others (?) https://github.com/NIEM/NIEM-Releases/wiki/Upcoming-Release 5

4.2 Release Content Submissions Major changes: NIEM-conformant XML schema start with most recently published schema (4.1 release) check conformance in ConTesA - https://tools.niem.gov/contesa Change Request spreadsheet enables a detailed change log Minor changes: Submit detailed description Submit changes to: niem-comments@lists.gatech.edu or Issue tracker for NIEM releases repo on GitHub https://github.com/NIEM/NIEM-Releases/issues https://github.com/NIEM/NIEM-Releases/wiki/Upcoming-Release 6

5.0 Release Plans Major release Content changes to Core and domains Architectural changes Core Supplements integrated into Core Projected schedule: Alpha 1 Beta 1 RC 1 Release January 2020 March 2020 May 2020 Summer 2020 Restart the Content Subcommittee following the 4.2 release (summer 2019) Review changes for Core Harmonization across Core and the domains Start discussing potential architectural changes for 5.0 now NTAC needs time to review and update the NDR Need time to update tools and training 7