Integrated Summary Tips

integrated summary

Quanticate's Medical Writing Team have summarized tips for the preparation of comprehensive, well-written, and focused integrated summary documentation.

Integrated Summary Tips:

Worst practices for producing an integrated summary

  • Not providing one!
  • Being too brief
  • Excluding data that do not support the effectiveness conclusions
  • Excluding pertinent safety data
  • Pooling data that should not be pooled
  • Replying on results from post hot meta analyses
  • Discussing experimental endpoints, rather than focusing on primary and co-primary endpoints
  • Including datasets without explaining how they were derived

Initial preparation for authors, contributors and reviewers

  • Always ensure most up-to-date templates and relevant regulatory guidelines are consulted and used throughout the project life cycle
  • Use professional approved style guides, and detail how to cover items not covered in style guides upfront
  • Use standardized methods for citation/referencing
  • Train authors to write granular documents
  • Train reviewers to review electronically

Planning for Lifecycle Management

  • Employ methods and tools for information sharing and knowledge management early in the process
  • Reviewers need to know what has changed and why
  • Consider impact of changes on future documents
  • Incorporate best practices for change history

Improved Reviewability

  • User effective hyperlinks and bookmarks; all documents from protocol through to summary should be hyperlinked and bookmarked at time of preparation rather than at the end
  • Write with electronic review in mind – FDA Good Review Practices
  • Create an efficient work flow
  • Produce submission-ready documents at all stages – employ a consistent QC checklist to make this happen

 

Get the Basics Right - Writing

  • Clear, concise, objective statements
  • Acceptable grammar and punctuation
  • Consistent writing style and Quality Control (QC) checklists to ensure intra and inter document consistency
  • Accurately crafted key messages; no mixed messages; same message throughout; focus on label claims
  • Ensure scientific interpretation, not regurgitation
  • Easy-to-read layout: 100% zoom, 12 pt font, Times New Roman
  • Easy to navigate - sufficient and accurate hyperlinks and bookmarks
  • Find the right balance between content re-use and avoid redundant repitition. Content does not mean simply copying and pasting from one document to another
  • Avoid repeating detail already given in the individual summaries of clinical trials; Don't cut and paste - hyperlink instead
  • For legacy trials, use the body of the Clinical Study Report (CSR) as the source, not the CSR sypnosis

 

Get the Basics Right - Statistics

  • Don't use secondary data unless they support label claims or reveal an issue
  • Provide comprehensive, detailed, in-depth analysis of results in aggregate with a clear rationale for the methods used
  • Utilise both positive and negative trials
  • Compare trials of similar designs: Weighting of sample size; Examine by common covariates or stratifications; Consider controls, durations, parent populations, endpoints, dropouts, statistical analyses
  • Consider inconsistencies in the data
  • Consider areas needing further exploration

 

Safety Summaries

  • Choose a single dictionary, and include dictionary and version in the methods. If older dictionaries used and re-coding is not possible, include details and/or a footnote to explain
  • Consistent terminology (e.g., If presenting >5% common adverse events [AEs], use this cut-off throughout)
  • Reference Quantitiative Satefy Analysis Plans (QSAPs) where applicable 
  • Discuss statistical issues with AEs; search the database for related AEs
  • Always show gender specific denominators
  • Mention denominator over time
  • Graph representation is good
  • Present clinically significant criteria for laboratory, ECGm vital signs and AEs; where applicable, referencing most current criteria
  • Multiple labs - ensure reference ranges in same unit of measure (applying conversions, where necessary)
  • Lab ranges and lab cut-offs often come up when reviewing

 

Efficacy Summaries

  • Mention limitations of sample size
  • Age, sex, race and geographic location; clinically relevant demographic factors
  • Consider US versus non-US - Does this have an impact on efficacy? Describe regional differences
  • Deal with the drop outs - planned versus actual
  • Consider and discuss risk benefit
  • Analyse postive and negative findings
  • Focus on pre-specified endpoints
  • Consider sub-populations
  • Use graphical representations such as Forest Plots
  • Data format is important (e.g., convert to the same unit of measure)
  • Use tables to combine and present data. All cells should have something or it may be construed as missing; use consistent footnote symbol order for every table
  • When pooling data, discuss and present selection process
  • State and discuss problems; it provides a more credible analysis
  • Include clinical information relevant to dose recommendations and individual dose responses
  • Listings are not required anymore by FDA; SAS viewer is used

 

ISS ISE Role of the Medical Writer

 

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Authors note: This blog was originally published on 05/04/2012 and has since been updated.

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