Wednesday, January 27, 2010

Clinical and Regulatory Biostatistical Submission Data Display - The Proper Use of Graphs

The design of a good graphic display for clinical and regulatory submission data must show the FDA reviewer the data and encourage the reviewer to think about the substance and storyline as described in the Clinical and Regulatory Development Plan and the Statistical Analysis Plan. What are you trying to convey to the FDA reviewer - don't be afraid to show it in a well designed graphic display.

Good Clinical and Regulatory Submission Graphs should:
  • emphasize data and storyline and not methodology, technology or "tricky" analytics that beat up the data for clinical and statistical significance
  • not distort what the data has to say
  • be closely integrated with statistical and verbal descriptions of the dataset and database
  • present many numbers in a small space
  • make large datasets and databases, integrated or otherwise, coherent
  • reveal the data in many levels of detail.

Just as good medical writing is a result of frequent communication between the medical writer, SAS programmer, clinical safety and efficacy and the QC team member - the same holds true with the development and creation of a good analytical graph - there must be frequent communication between the SAS programmer, analyst, QC, clinical safety and efficacy - for whom? - for the benefit of the FDA reviewer.

With regard to clinical and regulatory submissions - there is the overall submission team and additionally, there are submission subteams that must be responsible for the clear presentation of submission data from their respective areas of expertise.

"It takes a team to win".

No comments:

Post a Comment