2012 DIA eSource monitor-site-sponsor relationship
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Transcript of 2012 DIA eSource monitor-site-sponsor relationship
eSource: Changing the Monitor / Site / Sponsor Relationship
Edward S. SeguineCEOClinical Ink
Disclaimer
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Discussion Points
• What is eSource?
• Industry Metrics
• Business Model Implications
Audience Participation REQUIRED
Vote via Texting
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Poll: My primary work role is:
Practice Poll
What is eSource?
IVRS / IWRS
Digital Equipment (BP Cuff, EKG)
ePRO
Imaging Data EMRs ??
Electronic Source Documentation “This guidance is intended to promote the capture of source data in electronic form, which will help to:
– eliminate unnecessary duplication of data,
– reduce transcription errors,
– promote real-time entry of electronic source during subject visits,
– ensure accurate/complete data through electronic prompts”
FDA “We’re Here To Help”
FDA Perspective“For the purpose of this guidance, the terms eSource
documents and eSource data are used to describe source documents and source data for which the original record and certified copies are initially captured electronically.” (page 6)
“The eCRF is a vehicle used to assemble all the data from different electronic- and paper-based systems and makes it possible to capture and organize these diverse data in a manner that satisfies the study protocol and that enables the data to be systematically reviewed and analyzed.” (page 6)
Risk-Based Monitoring
“The guidance specifically encourages greater use of centralized monitoring methods where appropriate… The extent to which centralized monitoring practices can be employed will depend to some extent on accessibility of electronic records.” (page 1, 8)
“Source data verification and other activities traditionally performed by on-site monitoring can now often be accomplished remotely.” (page 5)
FDA “We’re Here To Help”
Poll: How much was spent on Phase 1-3 Clinical...
Poll #1
Poll #1
How much was spent on Phase 1-3 clinical trials last year?
$40 BILLION$1,200,000 for EVERY employee
involved in clinical trials
Source: Medidata CRO Contractor Fact Sheet; June 2012
Total Clinical Trial Costs
29%
26%
18%
12%
6%5% 4%
Monitoring Spend
R&D Spend Monitoring
Phase 1 $5.6B $1.2B
Phase 2 $8.8B $2.7B
Phase 3 $25.4B $7.9B
TOTAL $39.8B $11.8BSource: 2012 PhRMA Industry Report
UNSUSTAINABLE!
Clinical Trials Today
# Days Task Category
0 Record patient data on paper forms SOURCE
2 – 10+ Manually input data into database EDC
30 – 60+ On-site comparison of Source to EDC MONITOR
Clinical Trials Tomorrow
# Days Task Benefit
0 Record patient data on electronic forms No Paper
0 Automatically record to database No Errors
0 Remotely review source docs via web No Travel
Poll: Direct entry into CRFs meets site GCP re...
Poll #2
Source ≠ CRF
Criteria Source CRF
Timing Original Secondary
Workflow Site/Subject Sponsor
DataGCP/Protocol;Unstructured
Analysis; Structured
Owner Investigator Sponsor
Validation Review Verify
Explicit FDA requirements for Source21 CFR 312.62(b) Patient Case History
Source ≠ CRF: PE - eCRF
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CDASH Preferred Option A (5.14.1)
Source ≠ CRF: PE – Paper Source
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Source ≠ CRF: PE – eSource
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CRF ≠ Source: Vitals - eCRF
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CRF ≠ Source: Vitals – Paper Source
CRF ≠ Source: Vitals – eSource
Poll: Reviewing CRFs remotely is sufficient to...
Poll #3
Site Responsibility for Source
Inadequate/inaccurate case history is 2ND most common site audit finding
“Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation” - cited in 60% of investigator warning letters
“What is not documented is not done”
ICH E6 separates source DOCUMENTS from source DATA
Impact on Monitoring PlanSource Data Verification: what data does
need to be verified for accuracy
Source Document Review: what documents should be reviewed for context, trends, etc.
Remote Monitoring: what types of trial data, how frequently, with what tools
Changing Source data: where will changes be made, by whom, when, where is audit trail
Monitor – Site Communication
Fewer onsite visits, but more frequent and relevant site interactions
Data clarified by viewing context of document
Queries - total number and response time are reduced
Centralized tools ‘track’ monitor activity; what % of documents reviewed, how long?
Practical Realities
At what level is data signed? Investigator “signs” CRF, do they need to “sign” eSource
eSource design intent versus database; difference between “Yes”, “No”, “Null” values
Eliminate duplicate edit checks; if checked at source, no need for second check
Not all site employees have email address; how to verify identity, grant access
Drawbacks of Targeted SDV
Reliance on EDC data - not Source
No source document review
No benefit to site workflow
Sponsor discretion and risk
Sounds new; but really old
Reliance on process, not technology
Contact Details
Ed Seguine
CEO – Clinical Ink
336-464-0702
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