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

AMWAJournal.org     16

BEST PRACTICES FOR MEDICAL WRITING WITH A  
DISCLOSURE MINDSET
Speaker 
Thomas Wicks, MBA, Chief Strategy Officer, TrialScope/

Informa, Jersey City, NY

By Nisreen Shumayrikh, PhD
Clinical trials are conducted almost everywhere worldwide, 

and trial disclosure requirements continue to expand, with an 

average of 2 new trial registries going live every year. This global 

expansion can lead to inconsistent public disclosure of study 

protocols, trial results, and associated documents. 

 The inconsistency becomes apparent when the informa-

tion is disclosed through various registries, company trial 

websites, and publications and then assessed by recruit-

ers, industry and financial analysts, and patient advocacy 

groups.

 Regulators in various countries have started to include 

disclosure compliance in their inspection regime, whereas 

industry critics and transparency advocates continue their 

detailed assessments of transparency practices. Beyond 

these regulatory inspections and assessments, sponsors 

face additional risks if the disclosure decisions are not  

well harmonized. 

 In his presentation at AMWA’s 2021 conference, Thomas 

Wicks, Chief Strategy Officer at TrialScope/Informa, sug-

gested best practices to regulatory medical writers for 

authoring source documents such as protocols and clinical 

study reports (CSRs) with disclosure requirements in mind. 

Efficient Disclosure
To support disclosure, Mr Wicks suggested creating a pro-

tocol “disclosure template” that includes the main registra-

tion data, including the trial identification number, public 

and scientific titles, brief description, eligibility criteria, and 

others. A good starting point is adopting the registration 

data set developed by the World Health Organization and 

providing the protocol registration information from  

clinicaltrials.gov or EudraCT (if available) to local affiliates, 

partners, and contract research organizations (CROs) to use 

as their source data for registration to local registries. 

 Mr Wicks then discussed some disclosure consider-

ations regarding study endpoints. 

These include

• alignment: explain clearly how each endpoint aligns 

with objectives,

• measure: document how each endpoint will be  

measured,

• scales: explain scales and indicate the best and  

worst scores,

• objective: include measurement objective, 

• classification: classify endpoints and structure them 

(eg, primary, exploratory, secondary),

• templates: ensure that objective has one or more  

endpoints,

• definitions: define study process (eg, study dates, 

enrollment), and

• summaries: summarize all nonserious adverse  

events in a test. 

“Each study objective has to be backed up with an end-

point,” Mr Wicks said. 

Incorporating Plain Language
When preparing source documents such as the clinical trial 

protocol or CSR, consider the information needs of patients 

and potential trial participants. 

 The information relevant to patients and participants 

should be written in plain language as part of the protocol, 

including 

• the study title and a brief description,

• the description of the health condition, 

• the product description, 

• the key inclusion/exclusion criteria, 

• description of study procedures/assessments, 

• primary and, possibly, key secondary outcome  

measures, 

• additional context around age range and sex of the 

participants, and 

• length of participation.

 The advantage is that submitting these plain language 

elements to trial registries improves patient communication 

and benefits users like recruiters and patient advocates.

Regarding the source documents, Mr Wicks emphasized 

integrating plain language elements in the protocol, CSR, 

and even the informed consent form, which is often not 

Session Reports 

CONFERENCE

http://www.amwajournal.org
http://ClinicalTrials.gov
https://eudract.ema.europa.eu/


AMWAJournal.org     17Session Reports

a clear as could it be. Additionally, he suggested adding a 

plain language abstract to the study synopsis, especially 

when the sponsor does not plan to provide a separate plain 

language summary. Other handy tools include developing a 

plain language glossary and templates.

Prepare for Redaction and Anonymization
For participant information, AVOID the following:

• using pronouns in patient narratives; consider using 

“the patient” instead, 

• using “verbatims” with quotes by the investigator, as 

these may include unique circumstances that could 

describe a patient, or 

• including patient IDs in images of tables. If patient IDs 

are required, then either include tables with selectable 

text (instead of copied as an image) or keep table for-

matting consistent across all images to ease redaction.

For study or sponsor staff information and other identifiers, 

AVOID the following:

• adding names of the study staff with their organiza-

tional titles; instead, use only their study role,

• including contact information such as fax, phone, or 

email,

• incorporating CVs or certificates or adding them to an 

appendix,

• adding personal identifiers to bookmarks (such as 

patient IDs, names, study admin), or

• providing treatment allocation and group information 

throughout the document.

Other final considerations: 

• Limit duplication that requires duplicate redactions, 

for example, providing a table with patient narrative 

information followed by text with some of the same 

information.

• In the sample Case Study Report Case Report Form 

(CRF), use a clearly fake patient ID like XXXX or 0000 

(not even “1234”).

• Aim to keep page numbering consistent between the 

CSR and the PDF copy to help remove out-of-scope 

information.

• Because foreign language pages are out of scope, you 

may keep these in an appendix or remove them.

 These are some best practices for medical writing with 

a disclosure mindset. It is part of your job as a regulatory 

medical writer to have a basic knowledge of disclosure  

regulations and support trial transparency. 

Nisreen Shumayrikh is a medical writer and scientific communi-
cator at Guanine Medical in Vancouver, BC, Canada 

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

Author contact: nisreen@guaninemedical.com

* * *

BRIDGING THE GAP: TRANSITIONING INTO 
REGULATORY MEDICAL WRITING
Speakers 
Amber Carr, PhD, Medical Writer, Merck, Rahway, NJ

Savannah Mageau, PharmD, Medical Writer, Merck, 

Rahway, NJ

Shengjie Xu, PhD, Medical Writer, Merck, Rahway, NJ

By Stephany Panlilio, MS
The role of a medical writer is everchanging and requires a 

range of technical knowledge and soft skills to create cohe-

sive documents in preparation for submission to regulatory 

health authorities. Medical writers come from a variety of 

different backgrounds with varying levels of experience. 

For those looking to enter the field, there are a number 

of transferable skills from previous experiences, training 

opportunities, and techniques to bridge knowledge gaps in 

preparation for transitioning into a regulatory medical writ-

ing role. This article summarizes the experiences of Dr Carr, 

Dr Mageau, and Dr Xu as they each transitioned into regula-

tory medical writing.

Skills Leveraged from Previous Experiences
In their presentation, Dr Carr, Dr Mageau, and Dr Xu shared 

their previous roles in experimental research, pharmacy 

practice, computational research, and teaching and medical 

communication and the skills they gained from each that 

were transferable to their role as medical writers. The skills 

they found most applicable to medical writing are summa-

rized into the following 3 categories: soft skills, technical 

skills, and core knowledge.

Soft Skills
The soft skills of self-management and project management 

that Dr Xu gained from her time in experimental research 

have helped in her medical writing role. Managing time, set-

ting priorities, and working independently are critical as a 

medical writer, and developing these skills can increase  

productivity. Medical writers must be able to manage  

multiple project timelines and have the flexibility to adjust 

when something unexpected arises (eg, shifting research 

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