Common preventable errors in medical writing

A medical writer’s main goal is to deliver a flawless document that is easy to read and interpret by the target audience. To prevent any mistakes from slipping into a finalized document, it typically undergoes several internal review cycles by the collaborating expert team, followed by an independent quality control check performed by an additional medical writer shortly before finalization. In this article, we discuss the most common errors caught during these review processes and how medical writers can avoid them.

 

1. Inconsistencies arising from multiple contributing authors

 

Both regulatory medical writing and writing for medical communications require collaborative team efforts, typically and nonexclusively involving subject matter experts, regulatory and medical affairs professionals, clinical scientists, biostatisticians, and pharmacovigilance specialists. For example, contributions received from an epidemiologist and from a nonclinical expert may need to be integrated by the medical writer into the relevant sections of an initial risk management plan. It is crucial that all parties involved in the writing process closely interact and establish clear agreements before and during writing. These agreements should cover task allocation, timelines and deadlines for delivering contributions, and standardized terminology and writing conventions. Clear agreements help to minimize the risk of inconsistencies throughout the document, making it more coherent and easily readable. In addition, the medical writer is responsible for checking that the document is consistent throughout at any stage of the writing process.

 

2. Errors resulting from intermediary data updates

 

When data are updated during the writing process, for instance in case of a study report including results from only recently completed or ongoing clinical trials, the clinical development team needs to promptly inform the medical writer. It is especially in these study reports, where data are critical and complex, that errors, inconsistencies, and other issues are most likely to arise. These mistakes often stem from discrepancies between old and new data, miscommunication among team members, or insufficient oversight during the updating process. Therefore, it is the medical writer’s responsibility to verify the accuracy and consistency of the data included in the document, as well as any corresponding timestamps, against the most recent data provided by the collaborating team.

 

3. Text copied and pasted without proper adaptation

 

In many cases, different documents written for the same compound or medical device tend to overlap, often containing the same background information and reporting similar data. However, one should be careful with simply copying and pasting information without sufficient adaptation to the specific document, as this increases the risk of plagiarism and of introducing inconsistencies and outdated information. A useful tip is to always highlight copied text as a reminder to thoroughly review and modify it as needed.

 

4. Incorrect or missing cross-references

 

Effective use of cross-references can be crucial for maintaining the quality of lengthy documents. They should be used to refer to the appropriate section where details are provided, thereby avoiding unnecessary repetition. This reduces the probability of inconsistencies and discrepancies throughout a large document and enhances readability. As these cross-references can become outdated due to updates in the structure of the document, it is important to check them (or at least perform a spot check) before finalizing the document.

 

5. Discrepancies across document sections

 

A tip to keep the synopsis, conclusions, and results sections aligned, is to write the synopsis and conclusions at the very end, once the document’s content has been endorsed. However, this does not fully eliminate the possibility of final review comments that may impact the synopsis or conclusions, so make sure to be on the lookout for any necessary updates before finalization of the document.

 

6. Inadequate implementation of comments

 

As mentioned before, medical writing is a team effort. Adequate implementation of comments provided by the team during the different review cycles, as well as by another medical writer during quality control, is important to take the document to the next level. It is best to have an optimized workflow in place for comment implementation to make sure all comments are implemented properly and consistently, as agreed with the team.  If you would like to learn more about the review process and efficient implementation of comments, please refer to our Emtex Academy training ‘Implementing Comments – Best Practices’.

 

7. Insufficient checking of statements and citations

 

In many cases, a medical writer has to compile large amounts of data and other information retrieved from other team members into a document, even without having contributed to generating any of that content. Since the medical writer should act as the owner of the document, it is important that they check any concluding statements and citations. Paying critical attention to correctness and relevance of statements and citations, even those provided by expert team members, is important for ensuring the quality of the document.

 

8. Not opting for a lean writing style

 

In essence, lean writing is a clear and concise writing style that eliminates unnecessary elements and keeps the message to the point. It is a key concept in medical writing, as it makes documents easy to read and keeps key messages unambiguous. This approach includes the use of short sentences, as overly long sentences are prone to grammatical errors and often difficult to interpret.

 

If you would like to learn more about lean writing and how it can be applied in medical writing, please refer to our Emtex Academy training ‘Lean Writing’.

 

Emtex Life Science medical writers are highly skilled and well-versed, and they receive continuous training, enabling them to detect and rectify each of these mistakes in existing documents and to prevent these common errors when drafting new documents.