Abstract
The discussion section of a clinical study report (CSR) is often a source of doubt among medical writers. The advice is usually to keep the discussion section as short as possible and not go into any deep analysis or attempt to put the trial into context. The line of argument is that the best place to really discuss the findings is in the integrated summaries, where pooled data are presented and the focus is on the big picture. And as company positions may change over time, a discussion section that is too detailed and assertive may cause problems later. The ‘shorter is better’ approach is no doubt sound advice that is widely applicable, particularly to CSRs that will generally be read as part of a submission
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References
- E3 Implementation Working Group ICH E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; 6 July 2012 [cited 2012 Sep 1]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_QAs_R1_Step4.pdf
- ICH harmonised Tripartite Guideline: Structure and Content of Clinical Study Reports, E3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use; Step 4, 30 November 1995 [cited 2012 Sep 1] Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf
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