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Integrated Summary Tips Continued

  
  
  

integrated summary

Following on from the first post on Integrated Summary Tips in our blog we can continue to explore these below:

 

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

 

Related Blog Post - Integrated Summary Tips

 

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