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©2022 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

AMWAJournal.org     35

It’s a rather tacit revolution that happened on 

September 26, 2022, in the “What’s new” section 

of the https://clinicaltrials.gov website. A short 

announcement states that “A Plain Language 

Checklist for Lay Brief Summaries (PDF) is added 

to the Support Materials under Data Element 

Definitions, Templates, and Checklists. The checklist 

identifies plain language best practices to help 

investigators write brief summaries that can be easily 

understood by the general public.”

 This unemotional announcement is a tremen-

dous move toward more understandable entries in 

ClinicalTrials.gov (CT.gov)—that is, a move returning 

to CT.gov’s original intentions. The purpose of CT.gov 

was to make information on clinical trials available 

to the public, initially to “individuals with serious 

or life-threatening diseases or conditions, to other 

members of the public, to health care providers, and 

to researchers.”1 Hosted by the National Library of 

Medicine, CT.gov was to be a “consumer-friendly” data-

base that provides easy access to information about clini-

cal trials for patients and their families and members of the 

public.2 In 2007, by the US Food and Drug Administration 

Amendment Act (FDAAA), the mandatory registration of 

clinical trials was complemented with the requirement to 

make full trial results available.3

 However, over the years, CT.gov moved further and fur-

ther away from its initial intentions and became a website 

for pharma companies’ transparency experts, competitive 

intelligence analysts, investors, and clinical trial aficiona-

dos. This development was a consequence of the technical 

operationalization of the transparency regulations with-

out having the end user in mind. Responding to the grow-

ing disconnect between intention and status, CT.gov has in 

2019 initiated a modernization effort with the objective to 

“deliver an improved user experience.”

 To foster the overarching objective of transparency of 

clinical trial research activities, more and more informa-

tion is to be provided by sponsors and investigators about 

their clinical trials. The information itself is—however—not 

presented in a way that “normal people” can readily under-

stand. The disconnect between intention and current prac-

tice is particularly obvious for 2 data fields that are of great 

importance to patients: the Brief Title, a short title describ-

ing the trial, and the Brief Summary, a short summary that is 

meant to provide a general, high-level overview of the trial.

 As per CT.gov guidance,4,5 the text that sponsors are to 

enter in these data fields needs to be in lay language; that 

is, it needs to be understandable for the public. Despite 

CT.gov’s intentions, sponsors have not lived up to this.6,7 To 

the contrary, Brief Titles are often full of abbreviations and 

specialist language that renders them incomprehensible for 

most members of the public. This also applies to the Brief 

Summaries, which should provide a short, high-level sum-

mary of the clinical trial detailing its goal and the intended 

indication. From a patient view, this is particularly unhelp-

ful as the CT.gov website returns a list of study titles as a 

response to a search request (eg, trials in a disease area). 

Thus, the interested user is provided with a list of study titles 

that mean little to them because they often lack the special-

Thomas M. Schindler, PhD / BioNTech SE and Lay & Regulatory Writing, Mainz and Biberach a. d. Riss, Germany

On to the Next Level: ClinicalTrials.gov Goes (More Fully) Plain!

TOPICAL FEATURE

http://www.amwajournal.org
https://clinicaltrials.gov


AMWAJournal.org     36On to the Next Level: ClinicalTrials.gov Goes (More Fully) Plain!

ist knowledge to fully understand them. Furthermore, if the 

user then clicks on a title, they are shown the Brief Summary, 

which should ideally provide key information about a trial 

in understandable language. However, the user is often pro-

vided with a paragraph of clinical trial gobbledegook and 

insider technical slang written for the fellow specialist.

 Prior to the September announcement, CT.gov had  

supplied very little guidance on the content of Brief 

Summaries; therefore, the new guidance amounts to a 

major improvement. By explicitly providing a plain lan-

guage checklist, CT.gov reemphasizes the requirement that 

these key data fields need to be understandable to patients 

and the public. Should all go well and sponsors do imple-

ment the new guidance, key entries of CT.gov will become 

a lot more accessible for the public—a true revolutionary 

development, as the database gains a lot more usability 

for everybody.

 For people familiar with plain language writing, the 

checklist provided is unspectacular and summarizes 

the most important points of writing in plain language. 

Although CT.gov addresses the checklist to study managers 

and investigators, the task of developing useful study titles 

and understandable study descriptions is better handled by 

professional writers even better by professional writers with 

expertise in plain language writing.8 As anybody who wants 

to have a go will quickly find out, it is a challenge to provide 

good study titles and even more so to provide a good, useful 

study description. It is an even greater challenge doing this 

in a systematic way across different disease areas in the 

context of a larger company or research institution. Few 

study managers would identify patient-focussed writing 

as one of their core competencies. Hence, the new focus 

of CT.gov on plain language writing opens a new realm of 

activity for professional medical writers, particularly those 

with plain language writing expertise.

Author declaration and disclosures: The author notes no  
commercial associations that may pose a conflict of interest in 
relation to this article.

Author contact: lay_and_regulatory_writing@gmx.de or 
Thomas.schindler@biontech.de

References
1.  Food and Drug Administration Modernization Act (FDAMA)  

of 1997. Pub L No. 105-115 (November 21, 1997).
2.  Press release: National Institutes of Health launches 

“ClinicalTrials.gov." National Institutes of Health. Published 
February 29, 2000. Accessed November 9, 2019. https://www.nlm.
nih.gov/archive/20040831/news/press_releases/clntrlpr00.html

3.  Food and Drug Administration Amendments Act (FDAAA) of 
2007. Pub L No. 110-185 (September 27, 2007).

4.  ClinicalTrials.gov PRS. Bethesda: U.S. National Library of 
Medicine. Protocol registration data element definitions for 
interventional and observational studies [updated March 7, 2019]. 
https://prsinfo.clinicaltrials.gov/definitions.html

5.  ClinicalTrials.gov PRS. Bethesda: U.S. National Library 
of Medicine. Protocol registration and document upload 
quality control review criteria [June 27, 2018]. https://prsinfo.
clinicaltrials.gov/ProtocolDetailedReviewItems.pdf

6.  Viergever RF, Karam G, Reis A, Ghersi D. The quality of registration 
of clinical trials: still a problem. PLoS One. 2014;9(1):e84727.

7.  Schindler TM, Grieger F, Zak A, et al. Patient preferences when 
searching for clinical trials and adherence of study records to 
ClinicalTrials.gov guidance in key registry data fields. PLoS One. 
2020;15(5):e0233294.

8.  Leithold LHE, Brown CM, Schindler TM. Lay titles for clinical 
trials: a balancing act. Med Writing. 2018;27(2):55-58.

General Principles of 
Word Usage

www.amwa.org/online_learning
Choose the right word for accuracy and clarity.

http://www.amwajournal.org
https://www.nlm.nih.gov/archive/20040831/news/press_releases/clntrlpr00.html
https://www.nlm.nih.gov/archive/20040831/news/press_releases/clntrlpr00.html
https://prsinfo.clinicaltrials.gov/definitions.html
https:// prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf
https:// prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf



