Se ha denunciado esta presentación.
Utilizamos tu perfil de LinkedIn y tus datos de actividad para personalizar los anuncios y mostrarte publicidad más relevante. Puedes cambiar tus preferencias de publicidad en cualquier momento.

eSource, DIA EuroMeeting, Lisbon, March 2005

654 visualizaciones

Publicado el

Publicado en: Empresariales, Tecnología
  • Sé el primero en comentar

  • Sé el primero en recomendar esto

eSource, DIA EuroMeeting, Lisbon, March 2005

  1. 1. eSDI Group7 March 2005, LisbonBecky Kush, CDISCJane Scott, FDADave Iberson-Hurst, Assero & CDISC
  2. 2. Contents eSDI Group Areas of Interest Work to DatePsychometric Validation Interim Analysis eSource Next Steps Discussion
  3. 3. eSDI Group•  The eSource Data Interchange Group was formed to provide a forum for gathering input from the biopharmaceutical industry and the development of recommendations that could help address existing issues with the collection and use of eSource Data for clinical trials; the initial focus was on electronic Patient Reported Outcomes.
  4. 4. eSDI Group•  FDA and sponsors currently share a feeling that there is no clear direction on regulatory issues related to eSDI/ePRO•  CDISC was asked to initiate the eSDI group•  It was considered very important for this group to have a vendor-neutral, platform- independent perspective.
  5. 5. eSDI Group•  Formed in October 2004•  FDA requested input from industry representatives (specifically trials sponsors, site representatives and CDISC representatives) regarding the issues•  Comprised of two representatives from major pharmaceutical companies, one validation expert, three representatives of investigative sites, two CDISC representatives and five FDA liaisons
  6. 6. Areas of Interest•  Interim Analysis –  What are the issues?•  Psychometric Validation –  What are the issues? –  Touch points with System Validation?•  eSource –  How does industry move forward?
  7. 7. Progress to Date (1)•  eSDI Group Communications –  Teleconferences ~ every two weeks; minutes/e-mails to share ideas and identify issues –  Face to face meeting on 31 January•  Development of a Draft White Paper –  Rationale –  eSource Data Interchange •  (issues, relationship to regulations for paper, recommendations for adherence to regulations for ePRO/ eSource) –  Psychometric and System Validation –  Interim Analyses –  Issues for the Future
  8. 8. Progress to Date (2)•  Expert Focus Groups Invited for Comment –  23 February, Philadelphia –  7 March, Lisbon
  9. 9. Next Steps•  Revise White Paper and Solicit Broader Comment –  4-5 April, DIA ePRO Conference, Arlington –  11 April, SAS Users Forum –  CDISC Website•  Complete White Paper and Present Widely with FDA Representatives –  DIA Annual Meeting, Washington DC, June 2005 –  Potential Guidance on ePRO –  Webinars, other venues
  10. 10. Issues•  Collection of data without adequate psychometric validation•  Inadequate validation and control of systems used for data collection•  How to transition from the paper world to the eWorld in terms of audits, reviews, compliance to regulations•  No regulatory basis for Trusted Third Parties
  11. 11. Sense of Urgency•  ePRO data going directly from patient to trial sponsor (bypassing the investigator)•  Investigators not having a copy of or control of the source data•  Collection of data without Data analysis on the fly – during the collection process, without adherence to ICH E9 guidance on interim analyses
  12. 12. Interim Analysis•  Present the issues resulting from the concerns about the introduction of bias•  Detail the guidance –  ICH E9 •  Section 4.5 - Interim Analysis and Early Stopping –  FDA Guidance for Clinical Trial Sponsors (Draft Guidance – November 2001) •  Section 4.2 - Confidentiality of Interim Data and Analyses
  13. 13. Validation•  Examining the touch points between system and psychometric validation•  Psychometric aspect of ePRO instruments•  System validation aspects of ePRO systems•  FDA PRO draft guidance coming in April
  14. 14. eSource•  Motivation and Aims•  Method•  Analysis•  Recommendations
  15. 15. Motivation and Aims•  Motivation –  Desire to solve the issue –  Increase adoption•  Aims –  Something tangible to shoot at –  Detailed enough to allow debate –  Practical•  End Point –  Simple check list, well understood (what not how) –  Allows all stakeholders (FDA, Sponsors, Vendors & Investigators) to assess current and future technologies
  16. 16. Method•  Examine the paper process; if well executed, it meets the regulatory requirements•  What are the requirements that source documents must meet?•  What do the FDA, Sponsors and Investigators need (key requirements) from source documents?
  17. 17. Method•  Examine the life cycle of paper source documents•  Stand back and extract the requirements•  Consider –  Regulations –  Data Quality & Integrity –  Subject Safety
  18. 18. Paper Life CycleSelect Make Copy BLANK CaptureCreate POPULATED Study Ends ARCHIVED Clarify, View, Monitor or Inspect View or Inspect Destroy End of Retention Period OBSOLETE
  19. 19. Analysis of Process•  What are we doing? (The What) –  What is the action?•  Why are we doing it? (The Why) –  What is the purpose? •  What does it achieve? –  What are the drivers? •  What are the regulations? •  How does it contribute to data quality (ALCOA) and integrity? •  What impact on subject safety?•  Purpose is to identify the significant operations and the core requirements/needs of the various stakeholders (FDA, Sponsors and Investigator)
  20. 20. Paper Life CycleSelect Make Copy BLANK CaptureCreate POPULATED Study Ends ARCHIVED Clarify, View, Monitor or Inspect View or Inspect Destroy End of Retention Period OBSOLETE
  21. 21. Analysis of Process•  What are we doing? (The What) –  What is the action?•  Why are we doing it? (The Why) –  What is the purpose? •  What does it achieve? –  What are the drivers? •  What are the regulations? •  How does it contribute to data quality (ALCOA) and integrity? •  What impact on subject safety?•  Purpose is to identify the significant operations and the core requirements/needs of the various stakeholders (FDA, Sponsors and Investigator)
  22. 22. Requirements•  Initial analysis resulted in 9 requirements•  Requirements examined in the context of 21 CFR 11 –  Additional requirement•  Re-examined in the context of existing technologies/architectures –  Additional two requirements
  23. 23. Architectures/Technologies•  Case Report Form –  Paper CRF –  eCRF (Thin & Thick Client)•  Diaries –  Paper Diary –  eDiary (PDA, IVRS etc)
  24. 24. Requirements•  12 in total•  As they stand today•  Open for review, discussion and debate•  The detail is in the white paper•  All are mapped to regulations
  25. 25. Requirement 1An instrument used to capture source data shall be an accurate representation of the protocol ensuring that the data as specified within the protocol is captured correctly.
  26. 26. Requirement 2Source data shall be Accurate, Legible, Contemporaneous, Original, Attributable, Complete and Consistent (the ALCOA and Data Integrity requirement).
  27. 27. Requirement 3Source documents shall provide the ability to maintain an audit trail for the original creation and subsequent modification of the source data.
  28. 28. Requirement 4The storage of source documents shall provide for their ready retrieval.
  29. 29. Requirement 5The investigator shall store the original source document or a certified copy.
  30. 30. Requirement 6 The mechanism used to hold sourcedocuments shall ensure that source data cannot be modified without the knowledge or approval of the investigator.
  31. 31. Requirement 7The storage of source documents shall ensure they cannot be destroyed.
  32. 32. Requirement 8The source document shall allow for accurate copies to be made.
  33. 33. Requirement 9Source documents shall be protected against unauthorised access.
  34. 34. Requirement 10The sponsor must never have exclusive control of a source document.
  35. 35. Requirement 11The location of source documents, and the associated source data, shall be clearly identified at all points within the capture process.
  36. 36. Requirement 12When source data are copied, the process used shall ensure that the copy is an exact copy having all of the same attributes and information as the original.
  37. 37. Example – eDiary Trusted Third Party Data entered by Data stored by TTP, subject using a PDA viewed by investigator and is saved to non- via the web. volatile storage on the PDA. Sent to TTP database as and when communications available.Investigator Subject
  38. 38. Example – eDiaryRequirement RequirementAn instrument used to capture source data The storage of source documentsshall be an accurate representation of the shall ensure they cannot beprotocol ensuring that the data as specified destroyed.within the protocol is captured correctly. The source document shall allow forSource data shall be Accurate, Legible, accurate copies to be made.Contemporaneous, Original, Attributable, Source documents shall be protectedComplete and Consistent (the ALCOA and against unauthorised access.Data Integrity requirement). The sponsor must never haveSource documents shall provide the ability exclusive control of a sourceto maintain an audit trail for the original document.creation and subsequent modification of thesource data. The location of source documents, and the associated source data, shallThe storage of source documents shall be clearly identified at all points withinprovide for their ready retrieval. the capture process.The investigator shall store the original When source data are copied, thesource document or a certified copy. process used shall ensure that theThe mechanism used to hold source copy is an exact copy having all of thedocuments shall ensure that source data same attributes and information ascannot be modified without the knowledge the original.or approval of the investigator.
  39. 39. Example – eDiaryThe investigator Trusted Third Party shall store theoriginal source document or a certified copy. Data entered by Data stored by TTP, subject using a PDA viewed by investigator and is saved to non- via the web. volatile storage on the PDA. Sent to TTP database as and when communications available. Investigator Subject
  40. 40. Example – eDiary The mechanism Trusted Third Partyused to hold source documents shallensure that source data cannot be modified without Data entered by Data stored by TTP, the knowledge or investigator subject using a PDA viewed by and is saved to non- approval via the web. of the volatile storage on the investigator. PDA. Sent to TTP database as and when communications available. Investigator Subject
  41. 41. Example – eDiary The sponsor must Trusted Third Party never haveexclusive control ofa source document. Data entered by Data stored by TTP, subject using a PDA viewed by investigator and is saved to non- via the web. volatile storage on the PDA. Sent to TTP database as and when communications available. Investigator Subject
  42. 42. Example – eDiaryRequirement RequirementAn instrument used to capture source data The storage of source documentsshall be an accurate representation of the shall ensure they cannot beprotocol ensuring that the data as specified destroyed.within the protocol is captured correctly. The source document shall allow forSource data shall be Accurate, Legible, accurate copies to be made.Contemporaneous, Original, Attributable, Source documents shall be protectedComplete and Consistent (the ALCOA and against unauthorised access.Data Integrity requirement). The sponsor must never haveSource documents shall provide the ability exclusive control of a sourceto maintain an audit trail for the original document.creation and subsequent modification of thesource data. The location of source documents, and the associated source data, shallThe storage of source documents shall be clearly identified at all points withinprovide for their ready retrieval. the capture process.The investigator shall store the original When source data are copied, thesource document or a certified copy. process used shall ensure that theThe mechanism used to hold source copy is an exact copy having all of thedocuments shall ensure that source data same attributes and information ascannot be modified without the knowledge the original.or approval of the investigator.
  43. 43. Example – eDiary Trusted Third Party Data entered by Data stored by TTP, subject using a PDA viewed by investigator and is saved to non- via the web. volatile storage on the PDA. Sent to TTP database as and when communications available.Investigator Subject
  44. 44. Next Steps•  Experts: Today and DIA Lisbon –  Update in response to comments –  Additional technologies/architectures •  EHR –  Direct from EHR system –  Single-Source•  Public: April, DIA ePRO Conference, Arlington –  Update in response to comments•  Complete White Paper and Present Widely with FDA Representatives –  DIA Annual Meeting, Washington DC, June 2005 –  Potential Guidance on ePRO –  Webinars, other venues
  45. 45. Discussion
  46. 46. Information and Contacts•  eSDI Group Leaders –  Rebecca Kush rkush@cdisc.org –  Dave Iberson-Hurst dave.iberson-hurst@assero.co.uk

×