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Standardized Study Data: An Update Presented at the DCDISC Meeting

Standardized Study Data: An Update Presented at the DCDISC Meeting. Ron Fitzmartin, PhD, MBA Office of Strategic Programs Center for Drug Evaluation and Research U.S. Food and Drug Administration. 25 April 2014. Disclaimer.

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Standardized Study Data: An Update Presented at the DCDISC Meeting

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  1. Standardized Study Data: An Update Presented at the DCDISC Meeting • Ron Fitzmartin, PhD, MBA • Office of Strategic Programs • Center for Drug Evaluation and Research • U.S. Food and Drug Administration • 25 April 2014

  2. Disclaimer The views and opinions presented here represent those of the speaker and should not be considered to represent advice or guidance on behalf of the Food and Drug Administration.

  3. Steps Toward the Submission of Electronic Standardized Study Data

  4. Data Standards @ the Foundation of Review Regulatory Review Traceability Communication Common Tools Predictability Validation Data Quality Data Standards CSR Submission Protocol Data Capture

  5. A Glimpse at Progress: Standardized Study Data in FDA Fiscal Year 2013: Number and Percent of NDAs with Study Data Submissions in CDISC SDTM* * One or more explicitly stated SDTM studies (or study data structure that resembled SDTM). **New unique NDAs with data submissions (not previously submitted). Source: Office of Business Informatics

  6. Data Standards Governance Strategy, Policy & Guidance Communication External Collaborations* Automated Review Environment Project Operations Support Guides Data Standards Catalog Web Pages CSC Help eData Team * examples

  7. PDUFA V Goals – Section XII FDASIA Re-authorized PDUFA* “…develop standardized clinical data terminology through open standards development organizations (i.e., CDISC)” “… periodically publish final guidance specifying the completed data standards, formats, and terminologies that sponsors must use to submit data in applications.” *PDUFA: Prescription Drug User Fee Act

  8. Draft Binding Guidances &Tech Guide Public Comment Period Ends: 7 May 2014

  9. What is BindingGuidance? Guidance = “Please” • Recommends, • Suggests, • Encourages Do it! Binding Guidance has a bite! Binding Guidance = • Requires

  10. eStudy Data Guidance • Electronic submission of standardized studydata required for: • Certain INDs • NDAs • ANDAs • Certain BLAs • Including amendments, supplements, and reports

  11. Study Data Tech Conformance Guide • Guide supplements the eStudy guidance. • Provides technical recommendations / specifications for “e” submission of standardized data. • Consolidates Common Issues and Study Data Specs + much more. http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm

  12. eStudy Data Guidance Data Standards Catalog Dates Requirement Begins and Ends

  13. Therapeutic Area (TA) Standards Project Plan

  14. FDA TA Standards Objectives • Identify efficacy endpoints • Manageable increments • Collaborate with SDOs & TA Experts • Ensure Public Comment Open and Transparent Process Establish FDA’s requirements Express Requirements in Sustainable Standards Implement in Guidance to Industry • Adopt or adapt existing TA data elements • Harmonize with healthcare standards, as possible • Implementation Guidance • Standardized Study Data will become Binding

  15. Collaboration on TA Standards Development Clinical / Medical Societies Industry joint partnership Academia Government active participants Coalition for Accelerating Standards & Therapies

  16. FDA’s Role in the TA Project Stages • Scientific & Technical Input • Planning / Prioritization • Initial Expert Review • FDA Testing / Acceptance • Guidance • FDA Division Expert Review

  17. FDA’s TA Efficacy Requirements Process Tech Guide & Data Standards Catalog Acceptance Testing of CDISC Published TA Plan & Scope with the Review Division Efficacy Requirements Mapping & Report Communicate Results to CFAST

  18. Early Look @ Status*of TA Initiative • Schizophrenia • Influenza • COPD • Pain** • Alzheimer’s** % • Complicated intra-abdominal infection • Complicated skin infections ~58 TAs • Rheumatoid Arthritis • Diabetic Nephropathy • Renal Transplant • Osteoporosis • Multiple Sclerosis • Diabetes • QT Studies • Traumatic Brain Injury • ADHD • Irritable Bowel Disorder • Anticonvulsants • Comp Urinary Infection • Parkinson’s** • Virology** • Major Depressive Disorder • Hepatitis C • Oncology-Breast • Lipid Lowering • Anticoagulants for Atrial Fibulation • Prevention of Pregnancy • Treatment of Erectile Dysfunction • Acne • Tuberculosis** • Polycystic Kidney Disease* • Asthma* *Approved-Ongoing & Planned Projects or Published as of April 2014; **Published by CDISC

  19. Thank YouRonald.Fitzmartin@fda.hhs.govand the Data Standards Team

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