The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDM

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Historical Perspectives in CDM
Overview of the Draft Guidance
A Risked-Based Approach
Challenges to a Risk-Based Approach
Supporting a Risked-Based Approach

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The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDM

  1. 1. The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDM William Gluck, Ph.D. VP, Clinical and Consulting Services8 February 2013
  2. 2. Disclaimer ►  The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. ►  These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners. 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential – 2
  3. 3. Agenda ►  HistoricalPerspectives in CDM ►  Overview of the Draft Guidance ►  A Risked-Based Approach ►  Challenges to a Risk-Based Approach ►  Supporting a Risked-Based Approach ►  Summary 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  4. 4. Historical Perspectives in CDM ►  Drug development process •  Paper-based processing ► Electronic Data Capture • Interactive processing 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  5. 5. Historical Perspectives in CDM Age of technological advances •  Application of technology to a process: introducing risk •  Integration of technology as part of a risk-based approach 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  6. 6. FDA Draft Guidance ►  Risk-Based monitoring ►  1988 guidance withdrawn ►  Centralized (off-site) monitoring is encouraged and suggested to replace on-site monitoring when it can complete activities better or as well as on-site 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  7. 7. FDA Draft Guidance ► Well-defined risk-based monitoring plan could improve the quality and integrity of data • Publications suggest that data anomalies may be more readily detected ► Integrating technology appropriately to support a risk-based approach can enable decreased reliance on on-site monitoring (reduced cost) 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential – 7
  8. 8. A Risk-Based Approach ►  Protocol – Key Challenge ►  Developing strategies/plans to implement centralized monitoring ►  Enabling the Risked-Based Approach: Process Integration ►  Supporting the Risked-Based Approach 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  9. 9. Challenges to a Risk-Based Approach “The most important tool for ensuring human subject protection and high-quality data is a well-designed and articulated protocol.” 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  10. 10. Challenges to a Risk-Based Approach Guidance intends to assist in developing risk- based monitoring strategies/planning •  Tailored to subject protection and data integrity •  Focuses on critical study parameters •  Encourages use of a combination of monitoring activities •  Encourages greater reliance on centralized monitoring practices, where appropriate 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential – 10
  11. 11. Challenges to a Risk-Based Approach Well-Defined Monitoring Plans: •  Description of monitoring approaches (e.g., timing, intensity, activities, documentation) – Targeted SDV •  Communication of monitoring results •  Management of noncompliance •  Training and study-specific information •  Monitoring plan amendments 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential – 11
  12. 12. Process Integration Enables the Risk- Based Approach Key Processes must be integrated: •  Data Collection, Cleaning, Monitoring – eCRF design (including protocol deviations and edit checks) require both Clinical Operations and CDM – Query process is interactive/optimized between Clinical Operations and CDM – Dynamic monitoring-Real time data sharing between Clinical Operations and CDM 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  13. 13. Supporting the Risked-Based Approach CDM plays a critical role Technologically there are few challenges Process/Workflow Flow – KEY! Specific strategies to reduce risk Focus on data quality/integrity Define and share study metrics Enhance training and communication 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  14. 14. Data Quality/Integrity ► Identify critical study data and processes •  Endpoints •  Serious Adverse Events •  Randomization/ Blinding •  Consent •  Eligibility Criteria •  Risks specific to protocol design and conduct 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  15. 15. Define and Share Study Metrics Provide performance metrics Monitor data quality Identify higher risk sites Support 100%, partial, and remote SDV Dynamic analysis of data - identify trends Provide analysis to evaluate specific subject data – especially outliers 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential – 15
  16. 16. Enhance Quality with Technology Provide multiple training options: Face-to-Face Training Virtual Interactive Training Multimedia e-Training 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential – 16
  17. 17. Summary ►  Draft guidance acknowledges that changes to monitoring are OK ►  A risked-based approach does not eliminate risk – there is a balance of risk and benefit ►  CDM plays a key role in supporting risked- based monitoring and ensuring data quality 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –
  18. 18. Selected References Guidance for industry: Guideline for the Monitoring of Clinical Investigations, January 1988 Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring http://www.fda.gov/downloads/Drugs/.../Guidances/UCM269919.pdf CPGM 7348.810: Sponsors, Contract Research Organizations and Monitors (March 22, 2011), available at: http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133777.htm CPGM 7348.811: Clinical Investigators and Sponsor-Investigators (December 8, 2008), available at: http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133562.htm Collins, Rory. (2010, October) Quality Design of Clinical Trials. Presentation at CTTI work stream 3 expert meeting. https://www.trialstransformation.org/projects/effective-and-efficient-monitoring/developing-effective-quality-systems-in-clinical- trials-an-enlightened-approach FDA guidance documents regarding electronic records and signatures subject to 21 CFR part 11 http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126953.pdf and the use of computerized systems in clinical investigations. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf Two studies are on-going as of December 2010 that compare the effectiveness of on-site to alternative (e.g., centralized) monitoring methods - OPTIMON study: https://ssl2.isped.u-bordeaux2.fr/optimon/Default.aspx and ADAMON study: http://ctj.sagepub.com/content/early/2009/11/06/1740774509347398.full.pdf 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential – 18
  19. 19. William Gluck, Ph.D. VP, DATATRAK Clinical and Consulting Services DATATRAK International E-Mail: Bill.Gluck@datatrak.net 16th Annual Workshop in Japan for CLINICAL DATA MANAGEMENT SMART CDM February 7-8,2013 | Tower Hall Funabori, Tokyo, JapanConfidential –

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