Common Protocol Template (CPT) Initiative - Collaboration with FDA and NIH
- 1. December 2017 Collaboration with FDA and NIH
- 2. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * NIH Enhancing Stewardship of Clinical Trials
- 3. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 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 3
- 4. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION *
- 5. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 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
- 6. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Benefit of a harmonized protocol template 6 Patients Burden Time Clarity Quality Sites Workflows Planning Time Regulators Consistency Automation Traceability Streamlined Review Sponsors Reduce human error Automation Traceability IRBs Consistency Automation Traceability Streamlined Review
- 7. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * CPT NIH-FDA CPT and NIH-FDA Templates: Where we started
- 8. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 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 8 How did we do this and what did we find?
- 9. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * CPT NIH-FDA Off to a good start? 12 Section Headers, including Appendices 17 Section Headers, plus Appendices
- 10. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * A closer look TransCelerate CPT 1.0 Synopsis 2.0 Schedule of Activities 3.0 Introduction 4.0 Objectives and Endpoints 5.0 Study Design 6.0 Study Population 7.0 Treatments 8.0 Discontinuation Criteria 9.0 Study Assessments & Procedures 10 Statistical Considerations NIH-FDA Protocol Summary & Schematic 1.0 Key Roles 2.0 Introduction 3.0 Objectives and Purpose 4.0 Study Design & Endpoints 5.0 Study Enrollment & Withdrawal 6.0 Study Agent 7.0 Study Procedures and Schedule 8.0 Assessment of Safety 9.0 Clinical Monitoring 10 Statistical Considerations
- 11. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * • 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 Alignment = Organization + Prioritization + Semantics Harmonized Templates 1.0 Protocol Summary 2.0 Introduction 3.0 Objectives and Endpoints 4.0 Study Design 5.0 Study Population 6.0 Study Intervention 7.0 Discontinuation of SI & Ppt DC/Wd 8.0 Study Assessments & Procedures 9.0 Statistical Considerations 10 Supporting Doc & Oper. Consid. 11 References
- 12. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Best practices for intended users • Quality in protocol development • Site staff have one format • FDA & IRB reviewers have one format • Standards reduce error • Facilitates automation and re-use • Standard template supports a better INDs application • FDA modernizes workflow, extract data elements 12
- 13. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Released May 2017 NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template
- 14. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * NIH Clinical e-Protocol Writing Tool
- 15. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * Future Plans for NIH-FDA Template • Develop behavioral intervention and phase 1 protocol templates using NIH- FDA protocol format • Add behavioral and phase 1 protocol templates and instructions to electronic writing tool • Consider developing ability to integrate with ClinicalTrials.gov registration, IRB submissions, etc. 15
- 16. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * 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 16
- 17. Copyright ©2017 TransCelerate BioPharma Inc., All rights reserved. * Confidential - NOT FOR DISTRIBUTION * NIH-FDA Joint Protocol 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 Aynur Unalp-Arida James Witter Anne Zajicek FDA Melissa Robb David Cho Owen Faris Peter Kim Peter Marks Eileen Navarro- Almario Vaishali Popat Rachel Sherman TransCelerate CPT 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 FDA CPT Working Group 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 Sirisha Mushti, 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)
- 18. Thank you