An experienced medical writer can help authors and project managers improve the quality and speed of developing a clinical research manuscript. Here are some tips to keep in mind during the writing process:
Communication
- Identify authors and reviewers early
- Ensure that all team members understand the research question and working hypothesis
- Define lines of communications between team members
- Decide on timelines and expectations
Data Analysis
- Check that data are complete and adequately analyzed
- Determine which endpoints will be presented in the manuscript
- Make sure that all team members understand the data and their meaning
- Discuss any unexpected results with the authors
Writing
- Pick a suitable journal and follow its instructions to authors
- Check applicable reporting guidelines (CONSORT, ICMJE, GPP3, etc)
- Develop the Methods section first, followed by the Results, Introduction, and Discussion sections. Here are the main components to include in each section:
|
Methods |
Results |
Introduction |
Discussion |
|
Location and time span of study |
Patient demographics and baseline characteristics | A brief overview of disease and treatment | Interpretation of the results |
| Ethical approvals and research conduct | Patient disposition | Limitations of current treatments | Comparison between the results and published data |
| Inclusion/exclusion criteria | Efficacy data (tables and figures) | The rationale behind the current study | How the results fit or contradict the working hypothesis |
| Study design and endpoints | Safety data (tables and figures) | Research question | Limitations of the study |
| Statistical methods | Implications of the study and future lines of work |