Quanticate CRO Blog

Integrated Summary Tips Continued

Posted by Medical Writing Team on Fri, Apr 20, 2012

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

 

 

Tags: Regulatory Requirements, ISS/ISE, FDA, Integrated Summaries, Integrated Summary of Safety, Integrated Summary of Efficacy