Phase I pilot with EDC Astellas Leiderdorp Experiences

1
Phase I pilot with EDCAstellas Leiderdorp
Experiences

• Rinske Sieders, Maria Diviney, Trudy Kuipers

2
Agenda

• Why EDC implementation
• Steps before EDC pilot
• Pilot experience, lessons learned
• Phase I specific EDC requirements
• Questions?

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Why EDC implementation in Astellas Leiderdorp?

• History of Data Management with only paper based
  system
• Push from Clinical departments for EDC and
  e-diaries/ questionnaires
• Global CDMS standardization with EDC
  implementation effort

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Steps before EDC pilot

• EDC taskforce members assigned
• Data Management representatives
• Clinical representatives from Phase I and Phase
  II-III
• EDC taskforce initial steps
• Creation of User Requirements
• Demonstrations of vendors with EU office
• Evaluate system against User Requirements
• Identification of a suitable study and study team
  assignment
• Phase I
• Not too complex
• Clinical CRO with EDC experience and at
  acceptable distance

5
EDC System/Vendor Selection

• System selection was based upon
• Satisfaction URS
• Presence and size of European office
• Experience in Europe
• Experience with both early phase and late phase
  studies
• Ability to provide process support / advice

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Pilot Experience Study Characteristics

• Characteristics Pilot Study
• Phase 1 Study
• 3 Period cross-over design
• 24 subjects
• Safety and lab assessments
• Coding done outside EDC system
• Reconciliation with electronic lab data done
  outside EDC system
• At site
• Data was recorded in source book first
• Data was mainly entered by site data operators
• Majority of queries was answered by site data
  operators

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Pilot Experience Query Metrics

• Automatic queries
• Total 305
• Issued directly to site 185
• Candidate (for DM review) 120
• Actually opened to inv. 10
• Disregarded/deleted by DM 110
• Manual queries
• Total 153
• Issued directly to site 78
• Candidate (for DM review) 75
• Actually opened to inv. 25
• Disregarded/deleted by DM 50
• Originator for manual queriesCRA 70
• DM 83

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Pilot Experience Query Metrics (cont.)

• Cycle times for queries

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Pilot Experience Form Metrics

• Cycle Times Forms

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Pilot Experience - Challenges

• General
• Limited time available for EDC Task Force
• Short period between protocol finalization and
  first subject in? roughly 8.5 weeks for database
  set up? screening had already started
• Holiday season at timing of database set up ?
  resources
• No EDC SOP available? Study specific SOPs had to
  be written
• System
• Consistency checks with laboratory data outside
  EDC system
• Coding outside EDC system
• Flexibility? costly to get database updated

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Pilot Experience Challenges (cont.)

• Site
• Principal investigator who preferred paper. You
  need the individual investigators buy-in, not
  just the sites
• Data Entry done by site data operators, not by
  investigator/study nurse ? small delay in data
  entry
• Inadequate process for monitor ? Internet
  connection for monitor at site to slow to be able
  to follow the correct process

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Pilot Experience - Profits

• Early access to data for Study Manager
• More involvement Clinical in study set up
• Less queries for DM
• More control over study progress ? easier to
  collect live metrics
• EDC process defined locally which can be useful
  for Global project

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Pilot Experience Lessons Learned

• Need enough time between final protocol and
  first patient in? all set up related documents
  need to be created upfront
• Speak with operational staff of site, not only
  with business managers? investigator should be
  willing to use EDC
• Starting with draft versions of CRF / validation
  plan instead of final versions complicates set up
• Good set-up mandatory versus optional fields
• Need good understanding of how the system reacts
  visit completion (i.e. adverse events and
  ConMeds)
• Data Management should be on top of the study in
  order to gain as much time profit as possible

14
EDC specifics for Phase 1 studies

• Different kind of data collection can be required
  in Phase 1 studies
• Different logistical set-up Site data collection
  is set up around the subject in phase I
• (investigators office is central point in Phase
  II/III)
• Capture of actual (bedside) task performance
  times
• (Only dates relevant for phase II/III)
• On site integrated device data, such as Vital
  Signs data
• (Back-end data integration in phase II/III)

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Phase 1 EDC Requirements Data Management

• Quick and Easy trial design maintain (Global)
  Library of standard objects and procedures
• Communication tool with the system to the site
  (like internal e-mail system)
• Coding system integrated or easy interface with
  coding system
• Easy import of electronic study data such as lab
  data from Central lab
• Query and dataflow functionality
• Reporting capability (metrics and ad hoc data
  reports)
• Archiving facility (pdf of CRFs etc.)

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Phase 1 EDC RequirementsClinical

• Phase 1 studies short, intensive and exploratory
• Chronological design of eCRF
• Multiple parallel inputs in one center (e.g. 10
  volunteers in 1 room, all being assessed at same
  time)
• Possibility for direct bedside data capture
  assessment alert
• Highly adjustable without major efforts costs
• Clear overview of subject status, schedule of
  assessments
• Highly responsive fast
• Able to function in an offline mode ?fast
  synchronizing needed