What are Clinical Trial Summaries . . . and Why Should I Care?

Clinical trial summaries are a bit newer than many types of medical writing. I've talked to plenty of medical writers and editors who don't know what they are, though the word is spreading. When I started writing them in 2014 with an industry-leading company, they were really new, and the European Union rule that trial participants should receive a plain-language summary of the research was several years in the future.

What they are

Clinical trial summaries go by many names, including:

• Patient summaries -- Slightly problematic, as they're also for interested members of the public, research personnel who want to read an executive summary, health care providers (ditto), and of course, family members and other loved ones of participants.
• Plain-language summaries -- A good description. The EU regulation mandates that they be in plain language, though there's been a lot of discussion and work put into just what this means.
• Research summaries -- Few clinical trial participants, or even principal investigators at trial sites ever know how the study turns out. Work by Ken Goetz and others shows participants want to know. So ... research summaries.
• Lay summaries -- This is my least favorite, because although the summaries are supposed to be understandable, the title isn't. Quick, write down 6 things that come to mind when you read the word "lay." Plus, this word comes from ecclesiastical circles, so it's not exactly appropriate for science.

Clinical trial summaries are summaries of a research study, written for the people who took part and worded so other members of the public can understand what happened in the study.

Why clinical trial summaries?

Well, the EU made a rule ... and since most drug and device companies are global, this rule threw entire industries into a tizzy trying to, as one executive has written, do the impossible.

A lot of people who enter clinical trials have dire diseases. Or they're dying. The trial, either way, is important. Yet people were almost never finding out the results. This is unethical, and it discourages folks from signing up for research. "What did they do with my information?" "I never found out if the drug worked." As a certain commander-in-chief likes to say, "Sad."

Who writes clinical trial summaries?

The problem is, those writers aren't trained to write for the public. They're are often bench scientists, highly experienced in working with regulatory documents. Ask how many bullets should be in a bulleted list, or which punctuation marks are better for an academic audience? Not their area of expertise, any more than writing clinical study reports (CSRs) is mine (in fact, I wouldn't be able to attempt a CSR at all). So, when can you start a sentence with a conjunction? When writing for the public! However, one study has concluded that the desired reading level "could not be achieved" in writing clinical trial summaries.

But ... what if summaries were written by folks trained in plain language writing, as outlined in materials from the U.S. Centers for Disease Control?

After writing summaries for my client for a while, I got switched to plain-language editor. This was a good system, as the regulatory writing specialists were better at pulling information out of the regulatory documents than I was. (A CSR synopsis is a powerful tool for the plain-language writer, however.) The regulatory writing specialist would go through the clinical study report, or CSR, and draft a summary. I'd go back through it, check that we got the salient points, and then take the reading level down two to four grade levels. Here is an example.

Original summary text:

• The amount of [Drug X] in the blood was highest around Day 18 (about 3 or 4 days after the Day 15 dose) for all dose groups.
• Patients had the most [Drug X] in their blood 3 or 4 days after the second dose.

Book Reviews

Understanding Our Warriors
The United States has been at war since 2003. It also transitioned to an all-volunteer army -- no draft -- in 1973. Result? Most Americans don't serve in the military, and many don't know people who do. Health care providers might not know how to parse the multiple challenges that affect combat veterans.

Once a Warrior, Always a Warrior by Charles W. Hoge, MD, Colonel, US Army (Ret.), explains how the traits and habits that serve veterans well in combat can hamper them in civilian life. Hoge gives practical advice for stressful situations such as being in crowds, explains how to get needed health care, and helps spouses and other family members take the most productive approach to the warrior's issues. If you provide clinical care to military members or veterans, or have service members and veterans in your own circle, this book is worth reading.

Springtime in Amish country
You could do worse than spend a little spring (free) time with the good folk of fictional Rolling Brook in Holmes County, Ohio, a real place where the heroine of Isabella Alan's The Amish Quilt Shopmysteries comes to run a retail store, mend her broken heart, and find remarkable kinship with neighbors who live very differently than she does ... also, she finds a dead body about every six months, making the quaint town where the Amish community serves busloads of tourists a statistically dicey spot to live.

Remember the old "Calgon, take me away" ads? These mysteries will transport you to a different world and make you think about what it's like to fully live in an alternative community. They're also witty (yes, the heroine has an adorable dog and cat). Rolling Brook is picture-perfect, but far from saccharine. Like the butter and sugar in the Amish pastries, the charm and the human foibles are genuine.

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