Regulatory medical writers are tasked with generating high-quality clinical study reports (CSRs) promptly. To this end, statistical analysis plan (SAP) reviews are essential as they allow medical writers to verify that the SAP contains the information required for the CSR per regulatory guidance. This session will explain how to conduct SAP reviews and how to assess whether data presentations in addition to those proposed are needed for the CSR.

1. A Medical Writing Essential:
Reviewing Statistical Analysis
Plans
Anita Frijhoff, PhD, ELS
Medical Writer
Premier Research Group Ltd.

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Washington, DC - 2010 2

3. Why a SAP Review by Medical Writing?
• Medical writers ≠ statistical experts
• Why not just review draft tables, listings,
graphs (TLGs) after database lock?
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Washington, DC - 2010 3

4. Why? (cont.)
• Goal: clinical study report (CSR)
– high-quality
– quick development
• Statistical analysis plan (SAP) review from
MW perspective
– Planned analyses cover study objectives?
– Revised/additional data presentations needed?
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Washington, DC - 2010 4

5. What?
• What is a SAP?
– SAP: Text & TLG shells
• Text: Comprehensive and detailed description of the
methods
• TLG shells: Presentation of data analyses proposed
for a clinical study
– ICH guidelines: SAP finalized before database
lock to minimize potential for bias and define
scope
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Washington, DC - 2010 5

6. Agreement on SAP Reviews by MW
• Making the case for SAP reviews by MW
• Review scope
– No editorial review
– Summaries of data analyses appropriate for
CSR?
• Review timeline
– Time for review by MW
– Time for revision by Stats before deadline (eg,
database lock or delivery of SAP to client)
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Washington, DC - 2010 6

7. SAP Review - How?
• Required background
– Understanding of SAP content (general, phase
specific)
– Knowledge of ICH guidelines & regulatory
requirements
• Documents needed
– Protocol
– Annotated case report form (CRF)
– Other pertinent documents
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Washington, DC - 2010 7

8. SAP Review - How? (cont.)
• And… remember the review scope!
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Washington, DC - 2010 8

9. SAP Review – Step 1
• Ensure SAP endpoints and analyses
address all study objectives listed in the final
version of the protocol
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Washington, DC - 2010 9

10. SAP Review – Step 2
• Review the SAP text
– Comparison vs protocol (objectives, variables,
Stats section)
– Analysis populations
– Baseline definitions
– Imputation methods
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Washington, DC - 2010 10

11. SAP Review – Step 3
Review of TLG shells
• Listing shells
– All data points from CRF and external data
– Column headings vs CRF field labels and
external data labels
– Units
– Derived variables
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Washington, DC - 2010 11

12. SAP Review – Step 3 (cont.)
Review of TLG shells
• Table shells
– Data summaries per analyses described in the
SAP text
– Column and row headers
– Analysis population in title
– Data presentations easy to understand
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Washington, DC - 2010 12

13. SAP Review – Step 3 (cont.)
Review of TLG shells
• Graph shells
– Correct presentation per analysis described in
the SAP text (eg, Kaplan-Meier survival curve)
– Footnotes
– Legend
– Legibility
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Washington, DC - 2010 13

14. SAP Review – Step 4
• Final evaluation of data presentations (Y/N)
– Meet ICH guidelines and regulatory
requirements
– Summarize study results appropriately
– Customized/additional data presentations
needed
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Washington, DC - 2010 14

15. SAP Reviews by MW - Conclusions
• Require ample practice to become proficient
• Allow for TLG reprogramming early in study
• Efficiencies in other reviews
– Data listings produced before database lock
– Draft TLGs created after database lock.
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Washington, DC - 2010 15

16. SAP Reviews Are a MW Essential
• SAP reviews:
– Data presentations required for CSR are present
and error-free
• Gains in quality and time for CSR:
– Use table/figure shells in CSR shell
– Efficiencies in writing draft CSR
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Washington, DC - 2010 16