Writing manuscripts describing clinical trials: a guide for pharmacotherapeutic researchers
GE Pakes
Once researchers have completed a clinical trial and analyzed the data, they have a duty to make the results known to their peers by writing a manuscript suitable for publication in a biomedical journal. Before beginning any writing, those involved in the clinical drug trial first need to decide among themselves who is to be the first author and secondary authors, the readership they want to influence, and the most appropriate target journal to reach this readership. For content and formatting of the manuscript, writers need to carefully follow the instructions for authors as stipulated by the target journal. In general, a manuscript based on a clinical trial is presented sequentially in four sections: Introduction, Methods, Results, and Discussion (IMRAD). The introduction concisely presents background information about the topic that was researched in the clinical trial, provides the study hypothesis, and describes the study rationale, purpose, and objectives. The Methods section delineates the study design, subject/patient selection process, procedures, end points, and types of analysis conducted in the clinical trial to investigate the study hypothesis. The Results section presents the findings of the clinical trial, and the Discussion section interprets the meaning of these findings, assesses how the findings answer the study hypothesis, and compares the study data with findings reported in earlier studies. Writers should select a title for the clinical trial manuscript that is fewer than 10 words and which embodies the essence of the study findings clearly and specifically without being sensationalistic. Writers should create the abstract last; the abstract should provide an overview of the manuscript and stimulate readers' interest. Overall, following the above principles in writing a manuscript based on a clinical drug trial will make the actual writing easier and more enjoyable, as well as increase the possibility of the manuscript being accepted for publication.
