EDC implementation at Lundbeck Mike Bartlett System Project Manager

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EDC implementation at LundbeckMike
BartlettSystem Project Manager

• PSDM, EDC workshop
• 9th February, 2006

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LundbeckSpecialists in Psychiatry - Pioneers in
Neurology

• CNS Specialist Pharmaceutical Company
• Founded in 1927
• HQ Copenhagen, Denmark
• Sales and Marketing / Partners Worldwide
• Main Therapeutic Areas
• Depression, Schizophrenia, Alzheimers Disease,
  Parkinsons Disease, Insomnia

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Early EDC Experiences

• Monitors entering data using laptops2400 pt, 17
  countries in Europe, local labs, 1998-2000
• Part of trial, Germany sites3 investigators and
  3 monitors entering data, 2001
• DATAFAX PMS study19 countries in Europe,
  2002-2005
• Electronic diary1200pt, 19 countries in Europe,
  2003-2005
• Electronic CRF75 pt in UK, 2003-2004

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End 2004Lundbeck EDC Strategy

• Definition of EDC
• How much EDC?
• Scale-up strategy
• Impact on job-roles
• Costs Benefits
• Software Strategy

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Lundbeck EDC Strategy

• To be driven by the stakeholders
• Not just one department
• Own the knowledge
• EDC is a strategic competence
• EDC to be introduced stepwise
• Procedures to be revised and adjusted
• By 2007 conduct all phase 2-3 studies using eCRFs

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Lundbeck EDC Strategy

• Web-based, direct data capture ? eSource, hosted
  by Lundbeck
• EDC-specific tasks in a study to be coordinated
  by an EDC Coordinator
• Establish an EDC Team
• Develop EDCC role
• Work on EDC specific procedures

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EDC TeamA Cross-departmental function

• PROs
• Cross-departmental commitment
• Widens the procedure optics
• Helps target communication
• CONs
• Un-clear who is (or should be) in charge
• Lengthy democratic discussions

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Stepwise scale-up

• Why?
• Time to involve key-personnel in defining new
  procedures
• Time to get education plans in place
• Time to mental adjustment and acceptance
• Can be undertaken as an in-house enterprise
• Fall-back to paper exists as a safety net
• However
• This can seem less determined and allow
  resistance to grow

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Learning Curve

• Integrated SAE-reporting
• eTMF

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A few challenges
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Expect the Unexpected,The Oops Factor

• Discovered that site staff did not speak English
  at the site training
• The site-rooms other than those we had checked
  for connectivity were used
• Travelled hundreds of kilometres to perform a
  technical preparation at a site to find that it
  was closed that day

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A few more unexpected events

• Virus attack hit us during a training visit and
  left one site un-connected for 2 weeks
• Major power-cut in DK disconnected all sites for
  1 day ruined an installation visit
• The 00-800 Helpdesk number was blocked by
  hospital switchboard

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And a few more

• Primary contact for cable installation at site
  was on holiday
• for over a month
• Local road works prevented installation of cables
• Connectivity tests and training were performed
  late afternoon.
• When site went live, day-time performance was
  sloooow

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How can we face the Unknown ?

• Planning, Planning, Planning!
• Systematic walk-through of current SOPs in the
  workflow
• From study start to study closure
• This is a cross-disciplinary exercise (Invite
  your regulatory dept)
• Think what if
• Top priority keep the sites happy
• Investigator Survey identify concerns

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Reduce the Ooops-factor

• Un-expected events do happen
• Maintain a catalogue of Lessons Learnt
• use it in planning your next study

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EDC Dialogue with the Sites

• Feasibility Study
• Equipment
• Using the Computer in front of the Patient
• Pre Trial Visit
• General Information about EDC
• Technical Qualification of Site
• Midway Evaluation
• User friendliness of Screens and Edit-checks

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Training Concept
3-Step Training Program for CRAs

• Before Pre Trial Visit
• Between PTV and Investigator Meeting
• Close to Investigator Meeting

Site Staff trained on site by their CRA
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A Caring Site Approach is Vital
Everyone should be prepared for a little
hardship But not the Site Staff!
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Feedback from the sites

• Love it Easy from point of view of storage
  User friendly Easier from a CRF confidentiality
  point of view Like the availability of back-up
  worksheets
• The laptop has been less of an intrusion into the
  doctor/patient/carer interface than originally
  thought even less so than when writing
  information into the clinic notes this has come
  as a surprise
• Very user friendly and easy to navigate around
• Not afraid to call Helpdesk in resolving
  problems

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The Change Management Challenge

• 12 new/adjusted procedures
• Input to SOP-revision
• Role changes
• Communication Plan
• Identify target groups
• Road Shows, open dialog
• EDC-days, web-site, meetings

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Resistance Management, Day 0

• CRAs
• Affiliates
• Data Managers
• Management
• Clinical QA
• IT

• Facts about
• Job-Change
• Wins
• Losses
• Fears/Myths?
• Main Concern?

• Information
• Package per
• Target group
• Road shows
• Slide-kit
• Dept Meetings
• News Letter
• Web-Page

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Address Fears Worries

• Redundancy
• Nerd Technicality
• Delays in Trial Start
• Intrusive Element for Doctor/Patient
• Loss of Scientifically Important Sites
• Loss of Data
• Loss of Territory (power knowledge)
• Technical Problems at Site

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Open and Hidden Resistance

• Not sharing important information
• Nobody asked me ...
• Duplicating Work Efforts
• I will make my own
• Finding pre-texts for not doing the job
• This is against GCP
• Hostility
• We dont need you to
• Challenging the authority
• My boss has never told me to

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Risk Mitigation Plans, Day 1

• Plan A Prophylactic
• Plan B Curative
• We see Resistance to Change as a risk
• Top-priority in our Risk Assessment
• Plan A Targeted Information

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Our current eCRF Challenges

• Get the eCRF ready in time
• Heavy front loading of resources
• Patient Self Rating Scales are still paper
• Phamaco-economic studies with country specific
  page variations
• Cross-therapeutic studies
• Who is responsible for which pages
• Does the same split apply for ALL sites?

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Our current eCRF Challenges

• How to deal with negative sites or sites that
  fail technical qualification?
• Will there be web-connectivity in all the
  Lundbeck-Geography?
• Studies with visits in Patients home
• Studies involving other eEquipment (cognitive
  test systems)
• fear of techno-overload

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Our current eCRF Challenges

• eSource
• How much paper do sites REALLY use?
• Does the computer disturb the patient-doctor
  relationship?
• Is there a safe sponsor-hosting model?
• Maintain the right learning curve
• not too steep, not too flat
• Select the best-next-eCRF-study

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What we consider to identify eCRF candidates

• Appropriate planning period
• Interval between protocol synopsis and FPFV
• Site Routine with eCRF
• Number of patients per site Visit interval
• Recruitment difficulties?
• Logistics
• Number of sites, countries, time zones
• Number of local languages
• Site type (GP, Hospital, Specialist)
• Internet connectivity

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Learn from Others,Share the wealth

• Conferences
• Listen and learn
• Present your successes and failures
• Meetings and Committees
• DIA, eClinical SIAC
• eClinical Forum

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eClinical Forum

• An open, confidential exchange of experience and
  ideas
• Pharma, CROs and vendors in constructive dialog
  addressing current and future hot topics
• Valuable surveys about EDC and eClinical
• Informal and great fun
• Next meeting Brussels, March 2006

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Where Next ?

• Continuing implementation of strategy
• Convinced that using IT can be a driver for
  change
• Commenced work on eClinical Strategy
• To be presented to management Q3 2006

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Thank you for your attentionAny Questions ?