ABSTRACT

Once all the patients have been studied and the case report form completed, the trial enters analysis, i.e. the figures are examined and interpreted. It is hoped that analysis will enable conclusions to be drawn, and the trial to have a definite outcome. Clinical trial reports may be statistical or clinical — statistical reports describe the analysis and the results of any significance tests applied to them. Clinical reports describe the clinical context and relevance of the results and discuss the wider implications, e.g. in comparison to other treatments, the importance of reported side-effects etc. Clinical Research Associates and medical secretaries may find themselves organizing travel and venues as well as typing and proof-reading abstracts and papers for publication and preparing slides. Medical opinion leaders are usually invited to hear a series of papers presented by investigators. Papers must be written in a specified style to suit the journal of choice.