{"id":71095,"date":"2024-08-06T13:59:52","date_gmt":"2024-08-06T13:59:52","guid":{"rendered":"https:\/\/www.imperialcrs.com\/blog\/?p=71095"},"modified":"2025-10-13T11:59:16","modified_gmt":"2025-10-13T15:59:16","slug":"writing-clinical-study-materials-connect-with-patients-and-professionals","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/clinical-trial-writing-and-design\/writing-clinical-study-materials-connect-with-patients-and-professionals\/","title":{"rendered":"Writing Clinical Study Materials: Connect with Patients and Professionals"},"content":{"rendered":"

Whether you’re a sponsor, CRO, or part of a study team, writing clinical study materials that resonate with your audience is crucial for recruitment, referrals, and retention. Our tips will get you started and guide you through the writing process.<\/p>\n

You know all the standard writing rules: I before E except after C, use complete sentences, don\u2019t end a sentence with a proposition, etc. I\u2019ve always been fond of this principle from Strunk & White1<\/sup>: omit needless words. Agreed; there is no reason to write a paragraph when a sentence will do.<\/p>\n

For me, the most important rule of writing is this: respect your reader. You will find this tenet can cover a lot of ground and guide you along in much of your writing.<\/p>\n

Respecting your reader means you won\u2019t waste their time, you won\u2019t write above or below their reading level, and you won\u2019t lie. You will give them something of value, even if it\u2019s just a moment\u2019s distraction.<\/p>\n

That\u2019s the foundation. Now, let\u2019s explore writing for clinical research trials.<\/p>\n

This blog post is written from the Imperial perspective, as a company that supports sponsors and CROs and works in collaboration with study teams. However, these tips apply universally to creating materials that connect with their audience.<\/p>\n

Collaborate from the beginning<\/h2>\n

In a simpler world, the study team will mark our first drafts APPROVED NO CHANGES, and we will move on to design layout. That never happens. Nor would we want it to. Study materials are always collaborations, and the study teams are the ultimate subject matter experts because they have a vision for the study and have been living the study for some time.<\/p>\n

An alignment meeting between the creative team and the study team should take place before any writing begins. Basic questions should be asked, and an agreement should be reached. A good starting point includes the study team\u2019s preference regarding terminology. For example: study vs. trial, patient vs. participant, site vs. clinic, and study team vs. site staff.<\/p>\n

What term do they want to use for the study drug? The response to this question can be almost anything: study drug, study treatment, investigational drug, investigational study drug, investigational study treatment, etc. And here\u2019s a tip \u2013 don\u2019t assume the term used in the ICF is the same term preferred for the recruitment and retention materials.<\/p>\n

And regarding the study drug\u2019s name: our general rule is that the specific study drug name is not mentioned in any pre-consent patient materials.<\/p>\n

Determining these terminology preferences up front can save you a lot of editing time later.<\/p>\n

It\u2019s also a good idea to establish whether the screening visit information should be included in materials like the participant visit guides and visit calendars. Since participants may receive these materials after screening and enrollment, study teams need to specify whether or not to include screening information.<\/p>\n

Writing clinical study materials for professionals<\/h2>\n

Reaching out to physicians and other health care providers for patient referrals is a traditional and important recruitment initiative. The majority of respondents (62.3 percent) to one survey2<\/sup> said they would go to their health care provider first for information about trials (followed next by the internet, 22.4 percent). We routinely support sponsors and CROs by creating physician\/provider tools such as letters, website pages, and PowerPoint presentations.<\/p>\n

Protocols are wonderful sources of information when writing these materials. Protocols are exquisitely precise. Some protocol language can be easily adapted for use in materials to inform physicians about a study. However, protocols often apply linguistic streamlining that screams out for a writer\u2019s fine-tuning. A good example is protocols that get stingy with the definitive article \u201cthe\u201d and the articles \u201ca\u201d and \u201can.\u201d<\/p>\n

A protocol sentence like \u201cCohort B will take placebo\u201d is worded just a little too Tarzan-like for me. Let\u2019s insert \u201ca\u201d or \u201cthe.\u201d You know where it should be placed. Even better, let\u2019s add a couple more words: \u201cParticipants in Cohort B will take a placebo.\u201d When we are asked to review documents written by study teams for physicians, this type of edit is common. The content overall is useful; it just needs a little smoothing out.<\/p>\n

While the protocol is the best source of information when writing professional materials, the ICF is also useful. Though the ICF is written in more general language for the participant, it does provide (or at least one hopes it does provide) simpler information that might better communicate trial information to all.<\/p>\n

Writing clinical study materials for patients\/participants<\/h2>\n

\"\"<\/p>\n

Reading level of study materials<\/h3>\n

The patient and the professional are distinct audiences, and text that works for one rarely works for the other. I realize that this should be obvious, but what I call protocol creep happens much too often. Protocol creep isn\u2019t a person; it\u2019s a virus \u2013 we can lose sight of our audience and grow overly technical and dry, which should be avoided at all costs when writing for participants.<\/p>\n

When recruiting for a clinical trial, we know exactly who we are looking for because it\u2019s all there in the inclusion\/exclusion criteria. But how technical should we get? How do we make the information easy to understand?<\/p>\n

One study3<\/sup> found that the overall reading level for a cancer trial\u2019s materials was 11.7 (meaning 7 months into the 11th grade), and that\u2019s probably typical. For ICFs, the Johns Hopkins IRB4<\/sup> recommends writing at an 8th-grade reading level.5<\/sup> The U.S. reading level is 7th to 8th grade, so the Johns Hopkins recommendation seems like a sound goal. Johns Hopkins acknowledges that a typical trial document, because it is peppered with numerous necessary technical terms, may inevitably score a higher level.<\/p>\n

Optimize understanding<\/h3>\n

We have known for years that we need to broaden the appeal of trials to promote wider participation. A 2010 report6<\/sup> about optimizing patient recruitment revealed that one of the top reasons people turned down taking part in trials was that they didn\u2019t understand the trial, and it was too complex. I agree that many trials are complex. However, we must do better when writing clinical trial materials to appeal to a wide audience.<\/p>\n

When writing clinical study materials for participants, I begin with the protocol because of its precision. But the ICF is always close at hand. It reveals how the study team is communicating with the participant, especially with how it describes things like purpose, objectives, and treatments.<\/p>\n

It must be pointed out that the study team that wrote the protocol is not always the same team that wrote the ICF. Terminology between the two documents can be at odds, and the teams we work with are often much more familiar with the protocol than they are with the ICF. More than once, a study team has asked me where something I wrote came from, and they were surprised when I told them the ICF.<\/p>\n

Impactful communication in the clinical research space<\/h2>\n

The devil is in the details<\/h3>\n

Professional-facing documents<\/h4>\n

I find that study teams often desire (in my opinion) too much detail. In a letter or a website page introducing the study to a physician, cutting to the chase for these busy professionals is recommended. Physicians are known to roll their eyes (my dad was a doctor; I\u2019ve seen it myself) and will react dismissively when they are told something they already know. For example, I\u2019ve had physician letters return with edits that added details describing simple medical functions that are, without a doubt, well-known to the doctor who will be reading the text. Will the reader just skim over it, or will they feel disrespected? Let\u2019s not risk it.<\/p>\n

When the study team\u2019s edits to our first drafts of physician materials show up, we sometimes find that they have added a lot of criteria to the inclusion\/exclusion section. Let me caution you to always ask yourself what is and what is not useful to the referring physician. \u00a0Include broad criteria that give a snapshot of the study population.<\/p>\n

I will never forget the moment several years ago when a principal investigator, looking at the long list of inclusion\/exclusion criteria in a physician referral letter, chided her team: \u201cWe\u2019re asking doctors to refer patients, not screen them.\u201d<\/p>\n

Patient\/participant-facing documents<\/h4>\n

The length of any recruitment piece should be considered as much as the level of detail. I recently wrote the text for a trifold recruitment brochure to introduce the study to potential participants. It came back from the study team with significant additions, which I accepted. We returned it with a note stating that the text would no longer fit into a trifold brochure, and it would require an eight-page booklet. This was unwelcome news, and we were told to revert to our original.<\/p>\n

It could be argued that the additional level of detail was appropriate because it gave the potential participant a fuller understanding of the study. But I believe a trifold is more sensible because a booklet could be intimidating at this introductory stage. A briefer introduction is not misleading; included in our brochure were duration, number of visits, and a list of procedures. The brochure is meant to generate interest in the study, not to serve as an ICF or visit guide.<\/p>\n

The case of the ubiquitous legal department<\/h2>\n

Ah, yes, the legal department. The official buzz-killers of every writing project, particularly when it comes to the reading level for patients\/participants. Unfortunately, we have found that legal departments often add large words with many syllables that increase the reading level of the clinical trial materials for laypeople. This isn\u2019t unique to the clinical trials industry. It\u2019s Legal\u2019s job to step in and say no or reword text. Oh, you can plead and complain and pound your fist on the desk, but that will not help (not much, anyway). Instead, consider setting up a meeting with the legal department to discuss the importance of patient\/participant comprehension and come to a consensus on acceptable wording that preserves health literacy. 7<\/sup><\/p>\n

The legal department review is usually the final part of the process, and in every study I have ever worked on, without exception, the legal department has had the final say on every word of text. However, it can be wise to seek the legal team\u2019s counsel before you reach the final draft stage. More than once, I have asked the study team to run some of their edits by their legal department early because I was almost certain the text would not pass legal scrutiny. The latest was a patient thank you card that implied the study was a success and that the study treatment would be approved. Premature conclusions, to say the least.<\/p>\n

Let\u2019s summarize<\/h2>\n

I confess I have been a bit long-winded here, with the sharing of anecdotes and the touches of a manifesto. So here are some takeaways for writing clinical study materials:<\/p>\n