V37 N4 / 2022 

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

AMWAJournal.org     4

Over the past eight decades, the role and perceived value 

of what we’ve come to know as the medical writer has 

evolved. As the process of document production became 

more complicated and time-consuming, a separate group 

of specialists evolved to serve the role of “medical writer.” 

Although this role may not have been formally defined, and 

certainly not consistently so, this was the genesis of the pro-

fessional we consider to be the medical writer.

 When AMWA was founded, members were physicians 

who wrote. The documents that they generated were pri-

marily manuscripts for publication, content for medical 

textbooks, and, perhaps, case studies. In 1940, there were 

only rudimentary documents created for submission to a 

fledgling Food and Drug Administration. Indeed, regula-

tions, as we know them, had not yet been formulated.

 As regulatory document requirements became more 

structured and went beyond case study descriptions, 

expertise had to be expanded from medical and scien-

tific knowledge to an understanding of what would satisfy 

the requirements of regulators—requirements that were 

constantly evolving and becoming more stringent. At the 

same time, there was a move toward globalization and the 

need to serve at least two masters—FDA, the European 

Medicines Agency (EMA), the Japanese Pharmaceutical 

and Medical Devices Agency (PMDA), etc.

 The world of publications has, likewise, undergone sig-

nificant changes. At the outset, the end product was printed 

hard-copy articles in medical and scientific journals, the 

majority of which were only available by subscription to 

those with advanced degrees in the life sciences or to physi-

cians. For most of the profession’s history, there was no inter-

net and, therefore, no access by the general public to this 

information. We now live in a technologically enabled envi-

ronment where information is posted online, often unvetted, 

and assumes a life of its own—freely distributed, manipu-

lated, misinterpreted, and all too often “weaponized.”

 Through the years, the role of the medical writer was 

often determined by corporate, or even team, culture. 

Depending upon the experiences, inherent biases, and per-

sonalities of your team members, the medical writer was 

viewed as a secretary, editor, word-

smith, or valued interpreter of data 

and expert communicator.

 In preparing for this special 

topics edition of the AMWA Journal, 

I wanted to tap into a broad and 

varied spectrum of those who prac-

tice the trade of professional med-

ical writing as well as some who 

collaborate with them. In eliciting thoughts, I decided to 

create a series of virtual panels, thus allowing for a more 

conversational and interactive experience among partici-

pants. What has resulted is a series of collective thoughts on 

where the profession is going, and which forces will shape 

the context within which we will ply our trade going for-

ward. In one case, individuals formed their own “panel of 

one”; however, panels mostly comprised colleagues either 

from the same company or those who were invited because 

they were members of a particular professional organiza-

tion (eg, the Drug Information Association (DIA)) or rep-

resented a particular viewpoint within the medical writing 

community. 

 I provided a framework for the panel discussions, based 

on my 2020 “crystal ball” predictions, on the occasion of 

AMWA’s 80th year. I posited that the environment—scien-

tifically, technologically, socially, and politically—will con-

tinue to evolve, although inexorably toward what end, it is 

impossible to divine. 

 My musings, below, apply to all segments of the medical 

communications community—regulatory medical writers, 

information specialists, publication professionals, teach-

ing faculty…and others who represent the broad spectrum 

under the medical writing umbrella. Contributors were 

asked to choose one or more of the topics presented below 

and to share their perspectives, either as a consensus or as 

individual observations. The suggested overarching themes 

and subtopics follow; however, panelists tended to free-as-

sociate, and although some of the suggested topics were 

addressed, panelists sometimes elected to discuss topics of 

particular interest to them.

Art Gertel, PhD / MedSciCom, LLC, White House Station, NJ

The Future of Medical Writing: Gazing into the Crystal Ball

FROM THE GUEST EDITOR

http://www.amwajournal.org


AMWAJournal.org     5The Future of Medical Writing: Gazing into the Crystal Ball

TECHNOLOGY
• There will certainly be an increased use of artificial 

intelligence, automated templates, and eSubmissions 

to regulatory authorities.

• Data will become more available in real time as clini-

cal studies leverage personal data interfaces, including 

“wearables” or even “implantables.” This may result in 

the medical writer accessing, aggregating, interpret-

ing, and communicating trends and signals through-

out the course of a study, rather than only at the point 

of Last Patient, Last Visit. 

• The current coronavirus pandemic has accelerated the 

work-from-home model. Technology will continue to 

enhance this practice, removing many of the barriers 

and inconveniences we now face. It may become an 

opportunity to be a “work-from-home planet.” 

WHAT ABOUT THE AUDIENCE?
• Information may be provided to a broader range of 

consumers. No longer will results of studies be lim-

ited to regulators and scientific/medical cognoscenti. 

With greater access to posted documents in a variety 

of portals, the public will seek and access information 

that is important for informed decision-making. The 

patient will have a stronger voice in determining their 

treatment, and this will extend to end-of-life decisions. 

Social media will amplify results and will spread mis-

interpretations and poor quality data. Caveat emptor !

ROLE EXPANSION
• Medical writers will assume a stronger role as “guard-

ians” of best practices. Not only do regulations con-

stantly evolve, but so do publication practices. The 

medical writer will have to maintain a high level of 

awareness and familiarity with current best practices 

and will have to serve as a “gatekeeper” to best ensure 

that these are not violated. This will require that the 

medical writer assume the role of educator, communi-

cating the essence of these standards and the rationale 

for adhering to them.

GLOBALIZATION
• A single global regulator? Not likely, but a lot can 

happen in 80 years. The trend toward mutual recog-

nition among regulators will continue, with common 

guidance and templates. Yes, there will still be  

regional differences; however, the core dossier will 

serve all masters.

• Our professional associations (eg, AMWA, EMWA, 

ISMPP, etc) have represented a “Balkanized” commu-

nity, despite the significant overlap in membership 

profiles, educational program content, and common 

interests and goals. Recently, the three organizations 

mentioned have successfully collaborated to develop 

Joint Position Statements addressing systemic and 

institutional deficiencies. I trust that this will continue 

and hope that at some point, we will realize that we 

have a stronger voice through alliances not just within 

the medical writing community but with associated 

institutions (eg, academia, medical and scientific jour-

nals, regulators, etc). I have long been an advocate for 

the Intergalactic Medical Writers Association. Perhaps, 

one day!

OTHER THOUGHTS
• Pressure to release data in “real time” for publica-

tion – technology allows us to do so, particularly given 

the increase in use of patient-reported outcome plat-

forms that gather data in real time and adapt to prior 

responses. This allows the release of “raw data” that 

may have been only minimally vetted.

• Society will determine that resources are insufficient 

to provide all services to all patients. This rationing of 

health care may seem Draconian; however, in a world 

of limited resources, algorithms will be applied to 

human healthcare. This will result in a greater need for 

medical communicators to develop materials to edu-

cate the public, including lawmakers, about the ratio-

nale for allocation decisions. 

 The panels represented participants from across the 

globe, and I thank them for their insightful observations and 

suggestions as to how the profession might best confront 

unmet needs, opportunities for growth, and the challenges 

that have been long-standing, are only recently emerging, or 

that we may imagine in a cloudy future.

 The future will reveal itself over time. As one of my 

heroes, that great sage, Yogi Berra, likely said, “It's tough to 

make predictions, especially about the future.” 

Author declaration and disclosures: The author notes no 
commercial associations that may pose a conflict of interest in 
relation to this article. The author has met all of the author-
ship criteria recommended by the International Committee of 
Medical Journal Editors (ICMJE).

Author contact: medscicom@rcn.com

http://www.amwajournal.org