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Study Data Standardization Plan
Use Case Experience
Dave IzardMay 14, 2015
Client Use Case for Study Data Standardization Plan
• PreNDA Meeting Briefing Package for NCE– First discussion of clinical data details w/ FDA @ PreNDA meeting
• Thirteen Studies– 10 phase 1 (7 early, 3 recent)– 1 phase 2– 1 phase 3– 1 phase 3 extension
• Compound purchased from another company following 1st phase 1 study
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Goals for Study Data Standardization Plan
• Convey standards utilized at study level for clinical studies• Rationalize reason for limited legacy conversion• Rationalize decision for limited / no pooling of data
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Section 2 – List of Studies (2.2 Clinical Studies)
• Study Status– No formal definitions available for planned, ongoing & completed– Agency decisions made based on concrete study start date– Sponsor wanted “Study Start Date” and “Study End Date” with available
check boxes of “planned” & “actual”, coupled with a formal agency definition for “Study End Date” in order to use this table
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Section 2 – List of Studies (2.2 Clinical Studies)
• Study Design / Trial Blinding Schema / Diagnosis Group / Indication Type / Study Type– Protocols & CSRs already written using company / industry conventions– No desire or willingness to restate these items using controlled
terminology after the fact– Concern about potential requirement to write this way in the future
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Section 2 – List of Studies (2.2 Clinical Studies)
• Submit Study Datasets– Decision to submit study datasets is independent of the characteristics of
a study– A simple “yes/no” response is of limited value
• Multiple submissions for ongoing studies?• Submission w/ CSR vs. SPA vs. NDA vs. 120DSU
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Section 4 vs. Table Ultimately Produced
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CRF annotation standards need to be taken into
consideration…
Data definition
file standards could be different
across data types…
Section 4 vs. Table Ultimately Produced
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Does this add value?
Transparent rationale for use of legacy standards…
Observations
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Should probably remove hard version of Study Data TCG from
this section of document…
Observations
• This table only holds the information pertaining to the data utilized to support the original CSR
• Any assets created as the result of legacy conversion for other purposes are documented in a separate table
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Observations
• Need to add context (e.g., Tabulation Data, Adverse Event Coding) between Study Identifier & Expected Standard
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Study Data Standardization Plan• No mention of if / how / when pools
will be developed, submitted and potentially updated over time
• No mention of if / how / when individual studies will be submitted and potentially updated over time
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Observations
Actions to Consider• Get FDA buy in that pooled data
standardization should be recorded in this same document
• Separate standardization versus submission strategy