The Critical Role of Medical Writing in Patient Documentation for Clinical Trials

In the complex world of clinical trials, effective communication with participants is paramount. The language and structure of patient documentation play a crucial role in participant understanding, recruitment, and retention. Dr. Lisa Chamberlain James, Senior Partner at Trilogy Writing & Consulting, shares her insights on the importance of specialized medical writing in creating clear, accessible, and compliant patient documentation for clinical trials.

The Impact of Patient Documentation on Trial Participation

The quality of patient documentation can make or break a clinical trial's success. Lisa emphasizes the direct impact of these materials on both recruitment and retention:

"It is no surprise that the documentation that patients are given (the patient information sheet and ICF) has a direct impact on both recruitment and on retention. Documentation given to patients is certainly their quickest way to access immediate information, and also what they are advised to look at if they have any questions."

She paints a vivid picture of how poorly written documentation can lead to participant withdrawal: "Imagine the scenario -- your doctor or healthcare provider has suggested that you take part in a clinical trial. In the best-case scenario, they hand you some paperwork about the study and then discuss it with you, explaining and answering questions as they go. You agree to take part and sign the legal statement at the end to allow you to be enrolled. You then take the paperwork home and think it all over. You might have questions from your family and friends or want to check on some detail, and so you refer back to the paperwork, to discover that not only can you NOT find what you need because none of the headings make sense or are intuitive, but even if you can find the right section -- it's written in complete gobbledegook that scares the daylights out of you. At this point you are very likely to withdraw from the study and never want to be involved again."

Conversely, well-crafted documentation can enhance participant experience and trust: "Both of these scenarios have the opposite outcome if the patient can refer to their paperwork and find the answers they need easily and in a clear format that they can understand and contextualise. Their stress and anxiety are immediately reduced and they are assured that the information they have been given is accurate and unbiased. Plus, their trust and appreciation of the clinical trial sponsor is increased as they have been given information that has been thought through and designed with their needs in mind."

The Complexity of Specialized Medical Writing

Creating effective patient documentation goes far beyond simplifying complex terminology. Lisa explains: "A lot of people assume that writing for patients/ the general public/ potential clinical study participants is just about turning complex words into simpler ones. That's certainly part of it but writing in plain language goes far beyond that. Health numeracy and literacy principles must be understood and taken into consideration, along with an understanding of the target audience, diversity, and inclusivity principles -- and there is a huge variety in those aspects alone!"

She highlights the multifaceted nature of the task: "Cultural differences and sensitivities, unconscious bias in the writer and audience, and even considerations such as visual, learning and cognitive difficulties can all complicate the task and potentially render even a simple document into one that is not fit for purpose."

Moreover, medical writers must navigate complex regulatory frameworks:

"Regulatory Authorities have set regulations, guidelines, and in some cases, templates for the mandated plain language documents such as those related to clinical study recruitment, protocols, results, and risk management plans, and the medical writer must be aware of and understand them thoroughly to ensure compliance, plus put in the ongoing work to ensure that their knowledge is current."

Collaboration Between Medical Writers and Clinical Teams

Effective patient documentation requires close collaboration between medical writers and clinical teams. Lisa emphasizes the importance of this partnership:

"Collaboration with the whole clinical team is crucial when preparing patient-friendly information. The medical writer must thoroughly understand not only the procedures and science involved, but also the intention behind the work and the aspects that are most crucial for the clinical team so that the writer can explain all of this to patients to allow the patient to contextualise the information and to be able to accurately weigh the benefits and risks of the study, drug, or treatment."

She also highlights the role of medical writers in bridging the knowledge gap between clinical experts and patients: "A key role of the medical writer is to bridge this gap, to explain to the clinical team why concepts that are very straightforward for them might be unintelligible to the general public, and -- importantly- to suggest methods for explaining the information in a way that is accurate, concise, but also simplified enough that non-specialists can grasp and make use of the messages easily and quickly."

Tailoring Documentation for Diverse Populations

Recognizing the diversity of clinical trial participants, Lisa stresses the importance of tailoring documentation to specific audiences: "The huge variety of people, and their differing needs, means that any information designed for the general public must be tailored to the particular target audience. 'Patient-friendly' information can (and should) look vastly different depending on the demographic it is being written for."

She advises medical writers to focus on key messages and consider various aspects of communication: "Medical writers should think about what their audience knows already about the subject matter, but also -more importantly -- what they need to know. Time is a precious commodity, and no one has time to read irrelevant, out of date, or unimportant information and the medical writer is competing with everything else in a person's life to ask them to read the information they have prepared. The general public are not stupid – you will lose your audience if you ‘talk down’ to them, patronize, or have a lack of respect for them."

Emphasizing the importance of visual elements: "We are all visual creatures, and so graphics and the 'cosmetics' matter - a good infographic can convey a message more clearly and succinctly than words alone could ever do."

Background

Dr Lisa Chamberlain James is a member of PBC Group's Advisory Board, helping to shape content strategy across the COG Series.

Advisory Board: https://www.thepbcgroup.com/advisory-board

Meeting Series: https://www.thepbcgroup.com/event-series