Clinical Trials

❘❙❚■ Chapter 32 | Overview of ReportingDifferent types of reportsA well-written clinical trial report is the sound basis of passing on researchfindings. The most cited forms of research reports in academic life are those inmedical journals and conference presentations. However, equally important in themedical field are regulatory submissions for new therapies or press releases forthe lay public. As with any written description of past work, the focus and style ofa report should be tailored to the audience in such a way that its results arecorrectly understood. Perhaps the most difficult form of reporting is a pressrelease, which targets the general lay audience. While aiming to be simple itshould not promote over-interpretation of the findings, which the mediacommonly encourages for news value.Structure and quality of a clinical reportThe purpose of any report of a clinical trial is to clearly convey a very few keypoints or ‘headline findings’ based on the main aims of the study; these should beborne in mind throughout the write-up as the main thrust of the report shouldfocus on these key points. Before starting to write a report the author should thinkabout the reasons for writing that particular report and its audience/readership.At the stage of writing a clinical research report, the aim of the study and theresearch hypothesis have usually been sufficiently clarified. The style of the reportmust be tailored to the audience for which it is intended while still ensuring thatthe ‘headline findings’ of the trial are conveyed in a clear and accurate way.For example, is it a press release aimed at enhancing public knowledge of theresults? Is it a regulatory submission aiming to get a new treatment licensed?In the latter case there are usually clear guidelines about the requirements andformat of the reporting laid out by the regulatory authorities, which can beaccessed via their websites. Reports for interim analyses with the data and safetymonitoring board should also meet regulatory standards.In this chapter, we focus on writing a clinical trial report for a medical journal.The audience of a report depends on the journal that is chosen for publication.Hence, the language should be adapted in such a way that the journal’s readershipshould be able to grasp the methodology of the study and its results.The commonly accepted format of a trial report is an introduction and literaturereview, followed by methods, results, discussion, and a conclusions section. Anabstract should precede the introduction and a comprehensive list of referencesshould follow the conclusions. Acknowledgment of all trial personnel and366