Literature Searches for Clinical Medical Writers

The background section of virtually every clinical document requires the use of solid references that underpin disease prevalence, treatment options, and outcomes. Regulatory documents, in particular, lean heavily on these references and they are also critical for well-written manuscripts. Here are a few things to consider when tasked with performing a literature search to populate these sections.

1) Collaborate Closely with Subject Matter Experts (SME)

While assembling key information in a precise, thoughtful, and impactful manner is the job of a medical writer, the knowledge and experience provided by an SME should be the foundation of any background or discussion section. Prior to starting any project which requires building a background section as context for new data, identify who the SME(s) should be for your document and request their contributions early in the writing process.

2.) Plan adequate time

Undertaking a literature search and assembling a draft background section takes more time than you think. It’s also easy to get caught in the trap of following a trail of references which can lead you away from the subject focus and burn up precious time. Start by outlining a draft set of statements which identify the information you need to build the section and collaborate closely with your SME to provide the most appropriate references to source those statements.

3.) The Devil is in the Details

It’s not hard to google a subject and find references. However, the number of published sources for any particular subject can be overwhelming and the information provided is extremely heterogeneous. The challenge is assuring that the content of a reference accurately supports your chosen topic. It is important to pay attention to the source of the data (single institution/collaborative/registry), type of data (randomized trial/retrospective observational), timing (historical/current), and the population (diagnosis, line of therapy, selection criteria) and to include only data from those references which best align with the current to the focus of your document. If you have trouble making those distinctions, seek guidance from your SME.

4.) The Goldilocks Phenomenon

Another challenge is determining the right number of references needed to support your subject. Too few? The section looks incomplete and doesn’t provide your reviewer with a compelling context with which to consider the ensuing data. Too many? A full-on blitz in referenced material and citations can bury the reviewer in irrelevant information and obscure key messages. Settling on what is “just right” takes a lot of time, experience, and again, collaboration from your SME(s).

Conducting focused literature searches and selecting the correct sources is the key to strategic clinical documents. By partnering with SME(s), paying attention to details in your sources, and investing time into meticulous review and validation, medical writers can greatly enhance the quality and impact of their clinical writing.

Justin McLaughlin

CEO and Founder