Well-written documents, whether intended for regulatory submissions (clinical study reports, investigator’s brochure, clinical and non-clinical overviews and summaries, safety reports, etc), publications, medico marketing or other purposes, can have a significant effect on the market, industry, regulators and the perception of the authoring company. The effect can generally be measured when key messages are conveyed in an accurate, brief, and clear manner…what we call the ABC of good writing! While this might seem simple, surprisingly it’s very difficult to master.
The impact of a poorly written document can be significant. Let’s look at some of the most common reasons for not being able to author simple, clear and effective reports, especially when dealing with clinical study data:
– The volume of data generated from a clinical study can be intimidating for some writers. In an attempt to present all the data from a trial, writers often end up producing documents that are very data-heavy and difficult to understand.
– Whilst drafting a clinical study report or a manuscript, it is very important to be able to connect the dots in a clear and meaningful manner. Writers sometimes tend to forget to link why the study was conducted to the outcomes; i.e., what was/were the primary objective(s) and if they were achieved. By the end of the document, it’s often not clear whether the study achieved its primary goal or not.
– Another common tendency is data duplication. Being able to effectively summarize data from various source documents is a challenge and can result in the same data being written in text and also presented as a table/figure or is a complete copy/paste from the source documents (e.g., study conduct information from the protocol or statistical plan that is appended to a clinical study report). Writers often find it difficult to summarize only the key results.
An Effective Approach: Lean Writing
A different approach to tackling most of these challenges is to consciously follow “lean writing” until it becomes second nature to you. This raises the next set of questions – what is lean writing and why follow it? When writers follow a lean, or a streamlined approach, to authoring documents it helps them focus on the most important messages which results in better data organization and aids in developing a well conceptualized document. This ensures that readers will follow a clear and concise flow and conclusion.
Let’s look at some basic points that are easy to implement and will help us author lean reports or manuscripts:
– Have a clear vision: No matter how many outputs are generated for a study, start by identifying the outputs that represent the primary and key secondary objectives. This will give you a list of outputs that you need to focus on while authoring. Having a clear vision of what needs to be presented automatically helps a writer streamline the results and avoid the temptation of presenting everything in the report.
– Follow a logical flow: Now that you have identified the outputs that need maximum focus, follow the reverse pyramid approach for investing your time and efforts (see figure below) – where the area of a tier is directly proportional to the efforts you put in. Spend most of your time writing about the primary and key secondary results. This again helps to ensure your document stays lean and provides a clear understanding to the reviewers as to whether the study achieved its planned purpose.
– Crisp and to-the-point messaging: A writer should consciously spend time developing the ability to summarize outputs or information from source documents in a way that concisely provides the crux, while not duplicating everything from the tables/source – it is an art and most definitely can be developed with practice.
– Tables, figures, graphs, bulleted list: These are invaluable tools that writers have at their disposal and should always look at using them to convey important or complex information. The human brain is tuned to understand information presented graphically much more easily rather than pages and pages of text. I’m sure writers would have experienced this when reviewing documents (since all writers are also reviewers at some point). Let’s take this point as an example: are you able to easily understand this text or is it just simpler to get the gist from the figure below:
– Finally, it is important to note that simple and clear writing does not always mean the document should be kept short. It may so happen that you have to create tables/figures running across multiple pages to help convey complex data in an easy-to-follow manner. Thus, a good writer will constantly look for means to best present data from a study.
The table below includes a couple of examples on how to implement lean writing:
|Example 1: Subject Disposition (effective use of figure)|
|Of the 100 subjects who were enrolled, 80 subjects were randomized to XX group and 20 to placebo group. In the XX group, 70 (87%) subjects completed the study whereas 29 (13%) subjects withdrew from the study. In the placebo group, 18 (xx%) subjects completed the study whereas 2 (xx%) withdrew from the study. The reasons for withdrawal/discontinuation in the XX group were adverse events, protocol violation, non-compliance, and other reasons. The placebo group showed similar reasons for discontinuation as the XX group except for discontinuation due to adverse events. Of note, subjects in the 20 mg group had the highest number of discontinuations (5 subjects, 14.7%), most common reasons for discontinuation in this group included withdrawal of full consent and lost to follow-up (2 subjects in each category); subjects in the 100 mg group discontinued due to adverse events and full consent withdrawn; and subjects in the 50 mg group discontinued due to full consent withdrawn.|