The key to writing successful clinical trial study materials
The process of writing your clinical trial materials doesn’t have to be a tricky task. Yes, there are a few audiences you need to consider — the patients, the site, the providers — and you do need to know how to communicate effectively with each of these. But if you’re following these best practices, you’ll have effective study materials in no time.
So, what do you need to consider when writing your study materials to make them a success? Keep reading for 6 key things to remember.
#1 Use language that’s easy to understand
Have you ever read something and clicked off the page because it was overly complicated and just wasn’t making sense to you? Or constantly had to turn to Google to find out what words mean? You don’t want this to happen with your clinical trial materials. The best thing to do is use plain language that’s easy to understand. It isn’t a case of over-simplifying or “dumbing it down”, you’re just making sure the content is suitable for all literacy and educational levels, and is compelling to read.
Before you even begin writing, there are a few things to consider:
Research your audience so that you understand their current level of knowledge and demographics, and then base your language on that.
Be clear on the purpose of your materials and what information your audience will need. Then, create an outline that organises that information in a logical order.
During the writing process, make sure you keep these things in mind:
Write to your reader: The word “you” is powerful, and you should use it in your materials. It makes the materials feel relevant and draws the reader in. Also, use an active voice and write the actions the reader should do.
Make it easily readable: Use headers and break the content up with easy-to-read lists and tables.
Present the information in a logical order: Make sure the main message is at the beginning of the document, and ensure each paragraph has its own theme.
Remember plain language: Use everyday language where possible, and if uncommon terms, abbreviations and acronyms need to be used, make sure they’re defined clearly.
Be direct and use standard English: Use the most direct form of the verb, and keep the subject, verb, and object close to each other.
Think about how much information you’re including: Include only the details that are needed for reader understanding and avoid unnecessary descriptions.
Once you’ve finished writing, remember:
A fresh pair of eyes is always a good idea, so make sure another person proofreads the material and checks that it’s visually appealing, too.
It all comes down to the target audience and what they actually think of it. So, ask them for their feedback and be prepared to make any updates accordingly.
#2 Put the plain language into action for patients
Once you’ve got the plain language covered, you need to know how to put that into action to write clinical trial materials for patients that are easy to understand, engaging, purposeful and compliant. It doesn’t have to be as difficult as it sounds — simply follow these five steps.
Know your audience: You need to prove that you understand your patient population and their healthcare journey, otherwise you run the risk of providing content that isn’t relevant. So, do as much research as possible, and use outreach strategies to gain as many valuable patient insights as you can.
Make it clear what you want from your audience: What do you want your patients to do when they’ve read the material? Ensure your content is relevant and have a clear call to action.
Think “less is more”: Keep things simple and easy to understand, in terms of both language and design. Again, write directly to your patients in plain language, and present this in an easy-to-read font with some graphics.
Use balanced content and do not make promises: You should ensure the content is fair and make it clear that the sponsor is still investigating the treatment.
Be accurate: The study materials must be updated when protocol amendments occur. So, make sure all the information you’re providing to patients is in line with the latest protocol.
#3 Be consistent in style
There’s no doubt that you’ll be developing a range of materials for your clinical trial. To ensure consistency across all of your materials, decide on your preferences and consider following a style guide — will you use 12 or twelve? US or U.S.? And make sure you stick to it for consistency and professionalism.
#4 Engage effectively with physicians
Not only do you need study materials for patients, but you need them for physicians, too. Physicians and other healthcare professionals are often working against the clock — they have demanding schedules with little time for reading. It’s important that your materials are clear and factual to get the important information across, in a quick and simple way.
Following all the steps from #1 Use language that’s easy to understand, will certainly put you in the right direction here. But there are a few other things to consider too, like which type of materials you should provide.
For example, reading a lengthy clinical trial protocol and trying to remember all of the relevant information isn’t the easiest of tasks. Therefore, consider providing professional, protocol-specific materials to your physician, which will highlight the important points of the protocol. This could be a colleague presentation or a recruitment brochure. It’s also worth providing the patient materials too, like the patient referral letter, brochure, leaflet and posters, as this further explains the clinical trial in a simple manner.
#5 Consider writing for translations
It’s likely that your study materials will be translated into many different languages, so there are things for you to consider when writing your master document to make these translations easier down the line, and ensure they’re readable for an international audience.
Use clear language, consistent terminology, and words that have a single meaning
Use standard English and ensure the correct use of subject, verbs and objects
Keep sentences short
Write in an active voice and second person
Use international date and units of measure formats
Use slang words that may not be known in other languages
Use phrasal verbs like “carry out” or “check in”
Write long sentences and descriptive words that aren’t needed
Include contractions, abbreviations and acronyms (if possible)
Include ingredients or recipes as the units of measurements can differ across countries
#6 Align on the approval process
All of your content needs to be approved by the relevant committees before it goes anywhere. And with so many people reviewing your documents, it’s important to establish who is responsible for each task. To save time and money, get all of the relevant stakeholders involved early in the process, find out who can make what changes, who has the authority to make final decisions, and align on timelines.
Will you follow these best practices for your study materials?
By following these steps, you’ll be able to create successful study materials that are intended for the right audience, will promote study enrolment, and improve patient engagement. If you’d like to find out more about developing effective materials for your study, take a look on our website for many more insights. Alternatively, we love to chat, so feel free to reach out to us at firstname.lastname@example.org to find out how we can support you with your study materials.
Louise offers diverse experience, working in medical trials for the NHS, creative marketing, and medical writing for pharmaceutical companies. As a result, she’s perfectly placed to make sure our communications reach and engage every patient, whatever their needs.