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Preparing an eSubmission based on multiple trials, some of which are ongoing

Preparing an eSubmission based on multiple trials, some of which are ongoing – challenges for statistical programming Åsa Carlsheimer, Statistical Programming Director PhUSE October 9-11, 2011. Outline. Introduction Data standards Data repository Output programs

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Preparing an eSubmission based on multiple trials, some of which are ongoing

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  1. Preparing an eSubmission based on multiple trials, some of which are ongoing – challenges for statistical programming Åsa Carlsheimer, Statistical Programming Director PhUSE October 9-11, 2011

  2. Outline • Introduction • Data standards • Data repository • Output programs • Planning and communication • Key message

  3. Introduction • Drug FER123 was approved by FDA and EMEA in 2009 • Different dose and longer treatment duration now investigated • 1 pivotal phase III trial • 17 completed phase II-IIIb trials • 8 ongoing phase IIIb trials Scope of new eSubmission Combined safety & efficacy analysis for FER123

  4. Data standards • Implementation • Early 2009 based on draft CDISC ADaM 2.1 • Maintenance • All new trials across all projects and therapeutic areas • Benefits • One common standard • Customization, recognition, facilitating communication with other functions • Easy to integrate in a repository • Submission ready

  5. Migration process Study Analysis Database Compound Analysis Database (CAD) Repository Database . . . . . CAD CAD Studies included in the previous submission Study 1 Data repository Study 2 *.SAS Study 10 Migration to ADaM Submission repository . . Study 11 Create combined treatment codes *.SAS Study 12 Integrate repository Study 17 *.SAS . . Cut-off Validation of repository Study 18 *.SAS Harmonize MedDRA codes *.SAS Study 14 MedDRA dictionary Study 25

  6. Repository learnings • Discuss expectations on level of data cleaning for cut-off • Include time for coding of ongoing trials after cut-off in timelines • Agree on version of MedDRA dictionary for pivotal trial and Integrated Summary of Safety (ISS) • Document outcome of repository validation together with actions and responsible programmer • Easy to underestimate the resources & time needed for cleaning up the ongoing trials

  7. Output program set-up ISS/ISE Statistical Analysis Plan (SAP) *.SAS Outputspecification Standard programs *.TAB *.CGM ISS/ISE output *.SAS ISS/ISE unique programs Grouping macros *.SAS (>1100 TLFs) Subgroups (age, weight, race, geographic region, disease severity) Pooled trials (phase 2/3, phase IIIb), dose/regimens, controlled/uncontrolled

  8. Output program learnings • Include an option to present data by multiple trials when developing standard programs (for ISS/ISE) • >1100 TLFs need to split in to several documents (consider numbering) • Test transfer to eCTD tool (pdf-size, templates, bookmarks, hyperlinks)

  9. Planning and communication • Submission team 13 statistical programmers (including biostatisticians and off-shore) • Weekly internal programming/biostat meetings (status, issues, validation strategies, assign tasks to person) • One representative in the regulatory led cross-functional team • Structured programming approach using planning tools

  10. Delivery times after database lock • Pivotal phase III trial (500 TLF) within 1 week • ISE (200 TLF) within 2 weeks • ISS (900 TLF) within 3 weeks

  11. Key message • To prepare for a submission based on multiple trials, some of which are ongoing is a complex and challenging task! • Utilizing the following will facilitate the work and ensure timely deliveries: • Implemented ADaM standards • Maintaining data repository • Clear programming and validation strategy • Good communication & planning

  12. Questions/comments? • Contact information: asa.carlsheimer@ferring.com

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