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©2023 American Medical Writers Association. All rights reserved.  
ISSN 2163-5315

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AMWA: Thanks Dikran for taking the time to speak to 
AMWA. First, I would like to recognize the time and effort 
by the steering committee and authors of the GPP 2022 
update. This is a major update of the guidelines since 
GPP3,3 which was published in 2015. The work for the latest 
update started in April 2019, and the article was published 
in September 2022, so the entire process took more than 3 
years from start to finish. My first question is why there was 
a need for this major undertaking to update the GPP, and 
what are the main objectives of this update by the GPP 
steering committee and authors?

Toroser: The publication field has been moving and chang-
ing at an extraordinarily fast pace in the last few years. For 
example, with the emergence of various enhanced content, 
publications are no longer just black-and-white pieces in 
a journal. The COVID pandemic was an incredible catalyst 
for many of the changes. Because people were not traveling 
to attend scientific conferences in person, there has been 
a huge need for digital enhancements, such as audio and 
video recordings, to be accessed virtually and on demand. 
 Another important factor is that the audience for scien-
tific publications is evolving. The audience is no longer lim-
ited to a select few who are technically minded in the same 
field. Today’s audience includes those who are not experts 
in the same field, who are not experts at all, who are short of 
time, or who are from other parts of world. The changes in 
the audience and their needs are another force in shaping 
the changing publication field. These are among many rea-
sons to update the GPP guidelines.
 The latest GPP update builds on prior iterations of GPP 
guidelines and reflects the latest changes and advances in 
the publication field. It is worth mentioning that, as with all 
guidelines, GPP won’t be able to provide answers to all ques-
tions at work and requires day-to-day judgment calls by pub-
lication professionals to apply the principles in specific cases. 

AMWA: The GPP 2022 update covers a wider scope of pub-
lications. For example, in the “Scope” section, the authors 
described research areas applicable to GPP guidelines: 

besides clinical research, the scope now includes transla-
tional and biomarker studies, nonclinical research, health 
economics, real-world evidence (RWE), and outcomes 
research.  
 Why should we include these additional types of 
research under GPP guidelines? Are there differences in 
planning and developing publications in these research 
areas other than traditional clinical research?

Toroser: A wider scope of publications reflects the increas-
ingly complex nature of data and research in the health-

Good Publication Practice (GPP) 2022 Update: 
An Interview with Dikran Toroser
Qing Zhou, PhD, ELS / Regeneron Pharmaceuticals, Inc, Tarrytown, NY

INTERVIEW 

THEME ARTICLE

Dikran Toroser was educated in the 
United Kingdom and has a PhD 
in biochemistry from Newcastle 
University in Newcastle upon 
Tyne. He did his postdoctoral 
research in the United Kingdom 
at the Cambridge laboratory on 
genetics and then moved to the 
United States to work as a bio-
chemist and researcher for the 
US Department of Agriculture 
(USDA). He has an extensive background in scientific 
publications as well as medical writing. He has led sci-
entific publication teams involved with preclinical, 
clinical, and mature product studies and publications. 
Dikran is one of the founding faculty for the University 
of California San Diego medical writing certificate and 
a consulting director for the program. Active in pro-
fessional organizations such as the American Medical 
Writers Association (AMWA) and International Society 
for Medical Publication Professionals (ISMPP), Dikran 
most recently has been involved in compiling guide-
lines for publication professionals, including the AMWA-
EMWA-ISMPP joint position statement on the role of 
professional medical writers1 and GPP 2022, the latest 
2022 update of Good Publication Practice (GPP) guide-
lines for company-sponsored biomedical research.2

Dikran Toroser, PhD
Merck, Boston, MA 

http://www.amwajournal.org


AMWAJournal.org     11An Interview with Dikran Toroser

care space. For example, health economics and outcomes 
research became more important in terms of informing 
unmet medical needs as well as providing valuable infor-
mation on health economics relevant to policy and deci-
sion-making from a payer’s perspective. Research on 
real-world data (RWD) or real-world evidence (RWE is 
another area of growing interest and importance because 
RWD and RWE are playing an increasing role in healthcare 
decisions by regulatory agencies such as the US Food and 
Drug Administration (FDA).4

 Publication professionals today find themselves man-
aging publications arising from expanding research disci-
plines besides the traditional clinical research; therefore, 
it is helpful that the updated GPP now covers the work that 
we do. Because of the differences in the research process 
and methodology, the cadence in publication activities for 
these additional types of research may be different from 
those for clinical research. For publications on complex 
data or analyses, there are added challenges in making 
the publications understandable and meaningful to the 
intended audience. 

AMWA: GPP 2022 also calls out a few new publication types, 
notably enhanced content and plain language summaries. 
Definitions for these new publication types are provided 
in Supplement Section A. Guidelines on the planning and 
developing enhanced content and plain language sum-
maries are also provided in various other sections in the 
supplement, from policies and procedures (Section B) to 
specific process steps such as publication plans (Section E) 
and publication development process (Section H). 
 Why are guidelines important for enhanced content 
and plain language summaries? For organizations that 
have not routinely worked on these new publication types, 
what are some key considerations? 

Toroser: The need for these new types of publications 
reflects the fast-changing publication field and an evolving 
audience. The updated GPP guidelines support the use of 
enhanced content (such as video, audio, or infographics) and 
plain language summaries to augment the publication and 
increase its reach. For the teams who are new to these newer 
publication types, they would need to collaborate with stake-
holders at their organizations to incorporate good practice in 
day-to-day work. GPP guidelines emphasized that enhanced 
content and plain language summaries should be developed 
following the same ethical and quality principles as the main 
publication. It is also important to consult the journals and 
congresses for their policies and requirements on enhanced 
content and plain language summaries. 

AMWA: The supplement of GPP 2022 was significantly 
expanded and reorganized. There seems an emphasis of 
making this updated GPP more usable to provide guidance 
on day-to-day work. For example, Section B describes the 
roles of publication professionals in developing publica-
tion policies and procedures as well as sharing best prac-
tices and continued professional development. Sections D 
through H detail various process steps in publication plan-
ning and development of individual publications, covering 
topics from publication steering committees to publication 
working groups, from publication plans to the process of 
individual publications. 
 Can you elaborate a bit more on the rationale behind 
the expansion and reorganization of the supplement? Is 
the expanded supplement in GPP 2022 intended as a tool 
for team training?

Toroser: Thanks for asking about the aspect of training, 
which had been brought up many times during this current 
GPP update. An important goal of the GPP document is to 
facilitate training of publication teams on best practices, 
both on principles and on day-to-day work processes. 
 Yes, the supplement of the GPP 2022 update was reor-
ganized and reformatted to increase the clarity of various 
topics and to make the document easier to read. The sup-
plement is a comprehensive document with a large amount 
of information; it will be helpful for publication teams to be 
familiar with the structure of the document so they can con-
sult relevant sections to find guidance on certain topics.

AMWA: Publication professionals need to interact with a 
wide range of people—eg, company teams, authors, journal 
editors, and patients—in these various publication process 
steps and activities. Can you speak to the role of publica-
tion professionals, perhaps an underappreciated leadership 
role, in educating others and implementing the GPP? 
 What challenges may be faced by publication profession-
als in adopting GPP 2022? Any insights on how to overcome 
these challenges?

Toroser: The roles of publication professionals are evolv-
ing along with the evolving field. We are the gatekeepers 
of best publication practices in a complex and changing 
landscape, often faced with complex questions and ethical 
dilemmas. We shoulder important responsibilities of ensur-
ing that authors meet their authorship criteria, of working 
with statisticians and other teams to provide data and study 
materials to authors, and of meeting requirements from the 
journals and congresses. 
 The important roles by publication professionals are 
also supported by the AMWA-EMWA-ISMPP joint position 

http://www.amwajournal.org


AMWAJournal.org     12An Interview with Dikran Toroser

statement,1 which calls out the responsibility of professional 
medical writers in achieving quality publications in an ethi-
cal, accurate, and timely manner. Publication quality suffers 
when these responsibilities are not met to the full strin-
gency. From my perspective, there has been more and more 
appreciation of the leadership role played by publication 
professionals.
 In terms of challenges, the global nature of publications 
nowadays can be a challenge to navigate cultural differences. 
For example, authorship practice in another culture may 
require more nuanced considerations, including how we ask 
for feedback and approval from authors. This may require a 
good understanding of the culture and practice in a specific 
region to anticipate problems and come up with solutions. 

AMWA: Many AMWA members are freelance writers, some 
of whom provide medical writing assistance to compa-
ny-sponsor biomedical research publications. For freelance 
writers who are new to GPP guidelines, are there specific 
sections or aspects in GPP 2022 that they may focus on? 

Toroser: I very much appreciate the opportunity to reach 
out to professional medical writers in the AMWA audience, 
who are an extremely important part of the publication pro-
fessional community. My recommendation is that freelance 
writers should be closely familiar with the entire GPP doc-
ument, especially ethical and quality principles. I hope that 
the GPP guidelines become an essential reference docu-
ment for all medical writers. 

AMWA: Besides publication professionals and teams, it 
seems that the other audiences for the updated GPP 2022 
include journal editors, conference organizers, academic 
institutions, and the wider research community and public. 
Have the authors received feedback from the wider audi-
ence on the GPP 2022 update? Is there anything we can do 
to promote dissemination of GPP 2022?

Toroser: The GPP author group includes representation 
from the pharmaceutical industry, academic research-
ers, journal editors, and conference organizers. Also, the 
latest GPP update underwent review by volunteers from the 
public before it was finalized for submission. So, feedback 
from a wide range of perspectives was received during both 
the writing phase and the review phase.

 GPP guidelines have already become a cornerstone for 
publication processes and procedures in the industry, espe-
cially at large companies. I anticipate that GPP guidelines 
will be more and more widely accepted by journals, con-
gresses, and the academic research community. For exam-
ple, we already built links with organizations such as the 
Asian Council of Science Editors in the Asia-Pacific region. 
ISMPP is also collaborating with various professional orga-
nizations such as the Medical Affairs Professional Society 
(MAPS) and Drug Information Association (DIA) to discuss 
and disseminate the latest GPP update. 
 AMWA membership is a crucial audience for GPP. I 
encourage AMWA members who are involved in scien-
tific publications to get closely familiar with the GPP 2022 
update. It takes continued effort to disseminate the latest 
GPP guidelines; we all can do our part through discussions 
with colleagues and stakeholders at professional develop-
ment activities and in our day-to-day work.

Author declaration and disclosures: The interviewee (D.T.) 
and the author (Q.Z.) note no commercial associations that may 
pose a conflict of interest in relation to this article. The views and 
opinions expressed in this article are those of the interviewee 
and the author and do not necessarily reflect the views of their 
employers. 

Author contact: qzhou.writer@gmail.com

References
1.  American Medical Writers Association (AMWA), European 

Medical Writers Association (EMWA), International Society for 
Medical Publication Professionals (ISMPP). AMWA-EMWA-
ISMPP joint position statement on the role of professional 
medical writers. Medical Writing. 2017;26:7-8.

2.  DeTora LM, Toroser D, Sykes A, et al. Good Publication Practice 
(GPP) guidelines for company-sponsored biomedical research: 
2022 update. Ann Intern Med. 2022;175(9):1298-1304.

3.  Battisti WP, Wager E, Baltzer L, et al.; International Society for 
Medical Publication Professionals. Good Publication Practice for 
communicating company-sponsored medical research: GPP3. 
Ann Intern Med. 2015;163(6):461-464.

4.  US Food and Drug Administration. Real-world evidence. 
Published 2023. Accessed 26 February 2023. https://www.fda.
gov/science-research/science-and-research-special-topics/real-
world-evidence 

   

http://www.amwajournal.org
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