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Collaboration with FDA and NIH

Collaboration with FDA and NIH. November 2018. NIH Enhancing Stewardship of Clinical Trials. NIH-FDA Protocol Template Initiative. March 2015: NIH–FDA Joint Leadership Council agreed to jointly develop a clinical trial protocol template to improve quality of protocols received for review

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Collaboration with FDA and NIH

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  1. Collaboration with FDA and NIH November 2018

  2. NIH Enhancing Stewardship of Clinical Trials

  3. NIH-FDA Protocol Template Initiative • March 2015: NIH–FDA Joint Leadership Council agreed to jointly develop a clinical trial protocol template to improve quality of protocols received for review • Goal of the template • Provide a standard protocol format • Provide instructions for writing a complete protocol • Working group consisted of NIH and FDA staff • NIH Program staff, FDA reviewers, IRB members, Statisticians, clinical operations, etc. • Reviewed over 13 NIH protocol templates

  4. NIH-FDA Protocol Template Development • February 2016: Draft phase 2 and 3 clinical trial protocol template posted for public comment. • Numerous comments received from over 60 respondents and incorporated into revised template • NIH-FDA Working Group met regularly with TransCelerate to harmonize format of templates

  5. Benefit of a harmonized protocol template • Sites • Workflows • Planning • Time Sponsors Reduce human error Automation Traceability IRBs Consistency Automation Traceability Streamlined Review Regulators Consistency Automation Traceability Streamlined Review Patients Burden Time Clarity Quality

  6. CPT and NIH-FDA Templates: Where we started CPT – Release 3.0 (June 2016) NIH-FDA

  7. Review of TransCelerate CPT and NIH-FDA templates • Reviewed TOC and instructional content • Found many similarities • Used “best of” from each template • Learned from comments from public, IRBs and FDA • Agreed on flexibility within the template (2nd & 3rd level headings) • Resulted in significant updates from previous versions How did we do this and what did we find?

  8. Off to a good start CPT NIH-FDA 12 Section Headers, including Appendices 17 Section Headers, plus Appendices

  9. A closer look

  10. Alignment = Organization + Prioritization + Semantics • Simplified TOC • Moved sections and sub-sections: • Prioritized sections for the user: investigator & reviewers • Moved Schedule of Activities to Protocol Summary • Harmonized Heading Titles • Treatment v. Study Agent = Study Intervention • Harmonized subsections • Introduction: Study Rationale, Background, Benefit/Risk Assessment Harmonization achieved with May 2017 CPT release!

  11. Best practices for intended users • Quality in protocol development • Site staff have one format • FDA & IRB reviewers have one format • Use of industry standards reduce error • Facilitates automation and re-use • Standard template supports a better INDs application • FDA modernizes workflow, extract data elements

  12. NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template Released May 2017

  13. NIH Clinical e-Protocol Writing Tool

  14. Work Group Members From Several Offices • Office of New Drugs (OND) • Office of Strategic Programs (OSP) • Office of Translational Sciences (OTS) • Office of Biostatistics (OB) • Office of Clinical Pharmacology (OCP) • Office of Computational Sciences (OCS) • Office of the Director (OD)/ Center for Biological Evaluation and Research (CBER) • Office of Cellular, Tissue and Gene Therapies (OCTGT)/ CBER

  15. FDA CPT Working Group TransCelerate CPT NIH Michelle Culp Cynthia Boucher Christine Cutillo Daniel Falk Shanda Finnigan Adam Haim Barbara Karp Petra Kaufmann Lynette Nieman Sarah Read Megan Ryan Galia Siegel Steven Sparenborg Betty Tai AynurUnalp-Arida James Witter Anne Zajicek FDA Melissa Robb David Cho Owen Faris Peter Kim Peter Marks Eileen Navarro-Almario Vaishali Popat Rachel Sherman Vaishali Popat, OND IO Peter Kim, OND/OAP/DAIP Lisa Soule, OND/ODEIII/ DBRUP Martin Rose, OND/ODEI/DCRP Bob Temple, CDER/OCD Milena Lolic, CDER/OCD/PASE Ray Chiang, CDER/OMP Stephanie Shapley, CDER/OMP Melissa Robb, CDER/OMP Steve Wilson, OTS/OB Robert ONeill, CDER/OTS SirishaMushti, OTS/OB Che Smith, OTS/OB David Petullo, OTS/OB Lili Garrard, OTS/OB Ron Fitzmartin, CDER/OSP Ta-Jen Chen, CDER/OSP Jeff Florian, OTS/OCP Eileen Navarro Almario, OTS/OCS Daniela Vanco, CBER/OD Robert Sokolic, CBER/ OCTGT Provided comment separately on CPT: OSI, CDRH offices, OND/DPP (Mitchell Mathis) Mitzi Allred, Merck Ralf Bilke, BI TK Booker, Amgen Elizabeth Bygate, GSK Susan Colby, BMS Vivian Combs, Lilly Rob DiCicco, GSK Robert Ferendo Nareen Katta, AbbVie Diane Klatzman, J&J Bill Lander, GSK Amy Leishman, Lilly Mark Makurath, Merck Frederik Malfait Virginia Nido, Roche Nils Schlote, Roche Cathy Stein-Izsak, Allergan Stacy Tegan, Accenture NIH-FDA Joint Protocol

  16. Ongoing Collaboration with NIH-FDA Feedback from FDA CPT Working Group resulted in additional updates to CPT as part of November 2018 release.

  17. Thank you

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