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INTRODUCTION
Maintenance of Quality in Publications During 
Public Health Emergencies 
Timely release of data in the form of peer-reviewed publica-
tions is crucial in medical research and necessary for produc-
tive scientific discourse. However, during public health crises 
such as a pandemic, the need to communicate science rapidly 
can lead to abbreviated vetting and substantially increase the 
risk of compromised quality and accuracy in data analysis and 
reporting. Indeed, the pressing requirement for speed in tack-
ling a pandemic and the necessary collaboration between aca-
demia, industry, and regulatory agencies on an international 
level creates a significant dilemma: the need to rapidly release 
data on PubMed Central and other resources, such as the World 
Health Organization’s databases, while upholding the quality of 
the communication and the data. Maintenance of integrity and 
accuracy in scientific publications via a thorough vetting pro-
cess prior to public release requires time and implementation 
of quality-control measures. Medical communicators have an 
important role to play in this process.
 By way of their speed, some publication modalities, such 
as preprints, may seem particularly attractive when quick 
release of information and rapid scientific discourse is desired. 
However, because such preliminary scientific reports are gen-
erally not subject to thorough peer review, there is an inevi-
table increase in the concomitant risk of lower quality and lack 
of precision. Thus, full disclosure of whether a publication has 
been peer-reviewed and transparency about the quality-control 
process are absolutely required. 

 In this Joint Position Statement (JPS) from AMWA, EMWA, 
and ISMPP, we provide suggestions and a structured framework, 
including a number of practical recommendations that can 
be implemented to help maintain quality and avoid damaging 
public trust in scientific and medical communication. The prac-
tical recommendations in the current JPS are intended to sup-
port quality-control processes in both the acute phase of intense 
reactions during the course of a public health emergency as well 
as the longer-term evergreen need to maintain quality in medi-
cal publications. The persistent call for rapid sharing of scientific 
advances against a firm background of insistence on high quality 
enables acceleration of medical innovation. Safeguards are pre-
sented as a clear and concise checklist that can be used by jour-
nals, authors, and medical communicators in the preparation 
and review of manuscripts before submission.  
– Dikran Toroser, PhD, CMPP / Director, Publications Group 

Lead, Rare Diseases, Neuroscience, TAKEDA Publications, 
Cambridge, MA

– Gail V. Flores, PhD / Principal Writer, Encore Biomedical 
Communications LLC, Encinitas, CA

AMWA representatives to the authorship team for the AMWA-EMWA-
ISMPP Joint Position Statement on Medical Publications, Preprints, 
and Peer Review.  

Author declaration and disclosures: The authors note no commer-
cial associations that may pose a conflict of interest in relation to  
this article.

This joint position statement originally appeared in Current Medical 
Research and Opinion, DOI: 10.1080/03007995.2021.1900365.

AMWA-EMWA-ISMPP Joint Position Statement on 
Medical Publications, Preprints, and Peer Review 

1. BACKGROUND 
In medical publications, just as in research and development, 

quality depends on the expertise and integrity of researchers/

authors as well as qualified peer reviewers and journal edi-

tors. However, the laborious and time-consuming process of 

the traditional peer review1 can be compromised by the pres-

sure to publish quickly—particularly during a health crisis, 

when timely distribution of credible medical information can 

make a substantial difference.2 Recent examples of negative 

consequences are two articles on COVID-19 that were hastily 

published in high-profile medical journals and subsequently 

retracted.3,4

 Traditional peer review, although not perfect, remains the 

most frequently used process for vetting scientific publications. 

However, it has become more common for manuscripts to be 

released without prior review, which raises new concerns.

 The potential value of rapid publication should be weighed 

against the potential harm of inadequate validation of the 

final output. There is a danger that lowering the threshold of 

publication oversight sets a precedent that cannot be easily 

reversed, potentially eroding standards and public trust in 

medical science.2

 We have joined in a multi-party consortium among three 

eminent professional organizations for medical communi-

cation professionals—AMWA, EMWA, and ISMPP—to advo-

cate for the adoption of standards by all stakeholders to better 

ensure the integrity of published scientific and medical infor-

mation. Thus, the following Joint Position Statement has been 

 

2021-17-02 

                            

AMWA-EMWA-ISMPP Joint Position Statement on Medical Publications, 
Preprints, and Peer Review  
 

1. Background  
In medical publications, just as in research and development, quality depends on the expertise and integrity 
of researchers/authors as well as qualified peer reviewers and journal editors. However, the laborious and 
time-consuming process of the traditional peer review1 can be compromised by the pressure to publish 
quickly—particularly during a health crisis, when timely distribution of credible medical information can 
make a substantial difference.2 Recent examples of negative consequences are two articles on COVID-19 
that were hastily published in high-profile medical journals and subsequently retracted.3,4 

Traditional peer review, although not perfect, remains the most frequently used process for vetting 
scientific publications. However, it has become more common for manuscripts to be released without prior 
review, which raises new concerns. 

The potential value of rapid publication should be weighed against the potential harm of inadequate 
validation of the final output. There is a danger that lowering the threshold of publication oversight sets a 
precedent that cannot be easily reversed, potentially eroding standards and public trust in medical 
science.2 

We have joined in a multi-party consortium among three eminent professional organizations for medical 
communication professionals – AMWA, EMWA, and ISMPP – to advocate for the adoption of standards by 
all stakeholders to better ensure the integrity of published scientific and medical information. Thus, the 
following Joint Position Statement has been developed to provide practical and implementable suggestions 
to uphold data integrity and quality, and the transparency of medical publications.  

Note: We use the term “medical writer” to represent the spectrum of professionals who prepare 
documents either for submission to regulatory authorities or for publication in peer-reviewed journals.5 

 

2. Communication of research: issues and suggested solutions 
2.1. Preprints 
Preprints are preliminary scientific reports that are made publicly available online for anyone to read, 
comment on, and discuss before they have been peer reviewed. Some preprint servers scrutinize 
submissions for scope and for basic quality standards before making them publicly available.6,7,8 Once the 
preprint is posted, most reputable preprint servers assign a unique digital object identifier (DOI) to aid 
traceability. Authors can revise preprints according to readers’ comments and post iterative versions. 
Preprints are often not indexed on mainstream bibliographic services, although Europe PMC now indexes 
preprints,9 and there are standalone tools for searching named preprint servers to improve 
discoverability.10 

F
E

A
T

U
R

E

 

2021-17-02 

                            

AMWA-EMWA-ISMPP Joint Position Statement on Medical Publications, 
Preprints, and Peer Review  
 

1. Background  
In medical publications, just as in research and development, quality depends on the expertise and integrity 
of researchers/authors as well as qualified peer reviewers and journal editors. However, the laborious and 
time-consuming process of the traditional peer review1 can be compromised by the pressure to publish 
quickly—particularly during a health crisis, when timely distribution of credible medical information can 
make a substantial difference.2 Recent examples of negative consequences are two articles on COVID-19 
that were hastily published in high-profile medical journals and subsequently retracted.3,4 

Traditional peer review, although not perfect, remains the most frequently used process for vetting 
scientific publications. However, it has become more common for manuscripts to be released without prior 
review, which raises new concerns. 

The potential value of rapid publication should be weighed against the potential harm of inadequate 
validation of the final output. There is a danger that lowering the threshold of publication oversight sets a 
precedent that cannot be easily reversed, potentially eroding standards and public trust in medical 
science.2 

We have joined in a multi-party consortium among three eminent professional organizations for medical 
communication professionals – AMWA, EMWA, and ISMPP – to advocate for the adoption of standards by 
all stakeholders to better ensure the integrity of published scientific and medical information. Thus, the 
following Joint Position Statement has been developed to provide practical and implementable suggestions 
to uphold data integrity and quality, and the transparency of medical publications.  

Note: We use the term “medical writer” to represent the spectrum of professionals who prepare 
documents either for submission to regulatory authorities or for publication in peer-reviewed journals.5 

 

2. Communication of research: issues and suggested solutions 
2.1. Preprints 
Preprints are preliminary scientific reports that are made publicly available online for anyone to read, 
comment on, and discuss before they have been peer reviewed. Some preprint servers scrutinize 
submissions for scope and for basic quality standards before making them publicly available.6,7,8 Once the 
preprint is posted, most reputable preprint servers assign a unique digital object identifier (DOI) to aid 
traceability. Authors can revise preprints according to readers’ comments and post iterative versions. 
Preprints are often not indexed on mainstream bibliographic services, although Europe PMC now indexes 
preprints,9 and there are standalone tools for searching named preprint servers to improve 
discoverability.10 



AMWA Journal / V36 N2 / 2021 / amwa.org    59

developed to provide practical and implementable suggestions 

to uphold data integrity and quality, and the transparency of 

medical publications. 

Note: We use the term “medical writer” to represent the spec-

trum of professionals who prepare documents either for 

submission to regulatory authorities or for publication in peer-

reviewed journals.5

2. COMMUNICATION OF RESEARCH: ISSUES 
AND SUGGESTED SOLUTIONS
2.1. Preprints
Preprints are preliminary scientific reports that are made pub-

licly available online for anyone to read, comment on, and 

discuss before they have been peer reviewed. Some preprint 

servers scrutinize submissions for scope and for basic qual-

ity standards before making them publicly available.6-8 Once 

the preprint is posted, most reputable preprint servers assign 

a unique digital object identifier (DOI) to aid traceability. 

Authors can revise preprints according to readers’ comments 

and post iterative versions. Preprints are often not indexed on 

mainstream bibliographic services, although Europe PMC now 

indexes preprints,9 and there are standalone tools for searching 

named preprint servers to improve discoverability.10

 Preprints have been rapidly adopted by physicians and sci-

entists, their obvious benefits being the immediate availabil-

ity to their peers and the public, avoiding lengthy peer-review 

processes prior to release, and the option of readers to leave 

comments. However, there are issues associated with preprints 

that ideally should be addressed by standards jointly devel-

oped by a convened body of all stakeholders.

Issues with preprints:

• While preprints enable rapid release and discussion of data, 

many are never revised, and only about a third to a half are 

ever fully published.11,12 

• “Once the toothpaste is out of the tube, it cannot (easily) 

be stuffed back in.”13 Provocative or poor quality research 

results could be reported by the media, or posted and dis-

cussed on social media, with little regard to the preliminary 

nature of the findings.14,15 No amount of retrospective “tag-

ging” will have much effect. Misinformation or deliberately 

misleading or sloppy science can be freely circulated, cited, 

and believed ad infinitum, regardless of whether it is ulti-

mately debunked and retracted.

Our suggested solutions:

• Preprints should not be used as references in any medical 

publication unless these are cited in the manner of a per-

sonal communication, that is, as an in-text reference (using 

the preprint link, DOI, or both) rather than as bibliographic 

references. It should be clearly disclosed that the source is a 

preprint.

• Clearly distinguishing preprints from peer-reviewed articles 

might help to reduce the tendency of readers to view the 

work as fully vetted.14,15 This should be done by

° Watermarking the article, as is done, for example, by 

medRxiv and bioRxiv, with the information that it has 

not been peer reviewed. 

° Placing a clearly-worded disclosure in the body of the 

article highlighting that the findings have not been for-

mally peer reviewed.

• Pre-publication vetting: 

° Pre-publication checks by server hosts. MedRxiv per-

forms a basic screening process for plagiarism, nonsci-

entific content, and material that might pose a health 

risk, including material that might compromise exist-

ing public health measures.7 However, these checks 

should be more extensive and consistent across server 

hosts, and a comprehensive checklist should be used 

(Appendix I).

° Encouraging authors to ensure that preprints that have 

been subsequently fully published be marked as such on 

the preprint server and linked via DOI to the fully pub-

lished article.

2.2. Post-publication peer review
In post-publication peer review, an article is published in its 

original form, then subjected to informal (as with preprints) 

as well as invited peer review. For instance, with the model 

used by the F1000 publishing platform,16 articles are posted 

online after passing pre-publication checks and after an arti-

cle processing charge (APC) is paid. When posted, articles 

are assigned a DOI and opened to comments from registered 

users. Expert peer reviewers are invited to review in the usual 

way. All comments, peer review reports, and article revisions 

are available with the article, and once the article receives two 

favorable peer review reports, the final, peer-reviewed version 

is indexed in external bibliographic databases and becomes 

fully discoverable. The benefits of this model are similar to 

those of preprints – rapid access for readers and the option for 

readers to comment.

Issues with post-publication peer review: 

• The issues with post-publication peer review are basically 

identical to those of preprints, but it should be noted that 

the requirement for an APC would potentially discour-

age casual or low-quality submissions. Articles are clearly 

marked as “under peer review,” and the progress of that 

review is accessible to readers.



60 AMWA Journal / V36 N2 / 2021 / amwa.org 

• As with preprints, articles undergoing post-publication peer 

review should not be used as references in any medical pub-

lication until the peer review process is completed and the 

article is approved for publication. If the article is cited, we 

suggest the citation be made in the same manner suggested 

for preprints.

• Issues associated with traditional peer review also apply and 

are addressed in Section 2.3, below.

Our suggested solutions: 

• Our suggested solutions include those proposed for preprints;

however, we suggest that the publication be indexed by main-

stream bibliographic databases (if applicable) once it has 

been fully peer reviewed, as is done on the F1000 platform.

2.3. Traditional peer review
Traditional peer review occurs after a submitted article is 

accepted for consideration by a journal, then passed to 

expert peer reviewers. The reviewers’ comments are sent to 

the authors to use in revising their article, or else the arti-

cle is rejected after review. For rejected articles, authors can 

start the process again with another journal. If an article is 

revised to the peer reviewers’ satisfaction, the article is pub-

lished and assigned a DOI, after which the article is indexed 

in mainstream bibliographic databases. Peer review reports 

and revisions may or may not be available with the final arti-

cle, depending on the peer review model the journal uses. The 

benefit of traditional peer review is that information is released 

to the readers only after there has been quality control applied 

by subject matter experts.

Issues with traditional peer review 

• Lengthy review process, which may impede the timely 

release of valuable information – particularly in a pandemic 

or public health crisis

• Inadequate time for high-quality peer review

• Inconsistency among reviewers

• Difficulty in “recruiting” qualified reviewers, given time 

commitment, particularly in times of health crises when the 

most appropriate reviewers are likely to have a high clinical 

workload

Our suggested solutions:

• Authors:

° Submit rejection comments to second-choice journals, 

with itemized rebuttals and updates to the manuscript 

(portable peer review).17,18

° Be more accepting of editor referrals to cascade journals.19

• Journal editors:

° Accept, request, or require portable peer review as 

described above, thereby reducing the need for addi-

tional review cycles.

° Consider commercial back-end services that expedite 

peer review (eg, ResearchSquare [https://www.

researchsquare.com/], as used by the BMC journals 

and others).

° Form a rapid response team of reviewers, with appropri-

ate expertise, who can provide peer review with a quick 

turnaround time.

• Publishers:

° Standardize formatting requirements to expedite resub-

mission.20

° Offer fast-track options for potentially practice-changing 

work.

° Consider incentives for reviewers.21

3. SUGGESTED SOLUTIONS FOR ALL FORMATS
3.1. Quality control
• Make use of existing publication guidelines22–24 and 

available checklists25 to ensure high-quality publication 

development. 

• Include Clinical Trial Protocols and Statistical Analysis Plans 

(SAPs) as supplementary material.

• Ask all authors to sign an author form confirming that they 

had full access to the relevant data reported in their article, 

and accept responsibility for submitting the article for pub-

lication. Furthermore, the contributor statement should 

name the authors (at least 2) who have accessed and verified 

the underlying data, as suggested in the revised Lancet pub-

lication guidelines.26 

• Journals should clearly explain the initial quality review that 

editors perform on newly submitted manuscripts.

3.2. Training in peer review
• Authors, peer reviewers, and editors should be adequately 

trained in the nature and technical aspects of peer review.

• Guidelines should be used, such as those created by the 

Committee on Publication Ethics (COPE),25 along with the 

reviewers’ checklist in Appendix I.

• Medical journalists and the public should be educated 

on how preprints and pre-publications differ from peer-

reviewed literature.

4. THE ROLE OF PROFESSIONAL MEDICAL
WRITERS AND SCIENTIFIC COMMUNICATORS IN
EXPEDITING THE PUBLICATION PROCESS
• Evidence suggests that the use of professional medical writ-

ers enhances publication quality and speed,27–33 and such 

assistance has been associated with a reduced risk for retrac-

tions due to misconduct.34 If a qualified medical writer is 

https://www.researchsquare.com/
https://www.researchsquare.com/]


AMWA Journal / V36 N2 / 2021 / amwa.org    61

part of the team, they should be involved in the process as 

early as possible.5 The medical writer should have access to the 

clinical study report (if available), source data, and related doc-

uments, including statistical outputs and patient narratives, to 

the extent that data-protection regulations allow.

• Professional medical writers should have an active role in 

ensuring the high quality of publications, including their 

development, editing, and referencing,22,24,35 and the use 

of appropriate publication checklists.36 Medical writers 

and statisticians should be actively involved in peer review, 

during which the medical writer will critically assess the 

quality of the manuscript according to common appraisal 

criteria, thereby augmenting the traditional subject-matter-

expert review (Appendix I).

• Medical writers could also be involved in pre-publication vet-

ting, act as trainers, or both (see Section 3.2).

 As professional medical writers and communicators, we 

have identified areas that could benefit from increased quality 

assurance. We have suggested some processes that we believe 

would better ensure effective oversight of scientific and medi-

cal publications, whether in the context of a health emergency 

or not. To maintain confidence in published science, each 

involved party (including the reader) must take responsibility 

for exercising their best judgment and selecting information 

from sources with good publishing practices that are rigorous 

and transparent.

5. ACKNOWLEDGMENTS
This joint position statement was reviewed and approved 

by representatives of AMWA, EMWA, and ISMPP. It was also 

reviewed and approved by representatives of EFSPI (European 

Federation of Statisticians in the Pharmaceutical Industry). 

Preparation of this statement was possible thanks to the efforts 

of the members of the Writing Committee (Slavka Baronikova, 

Beatrix Doerr, Art Gertel, Andrea Rossi, EMWA; Gail V. Flores 

and Dikran Toroser, AMWA; Jackie Marchington and Rob 

Matheis, ISMPP; and Todd Pesavento, The Ohio State 

University). Also, we thank the independent reviewers, Alison 

Abritis, Andrea Bucceri, Andrea Cortegiani, Martin Delahunty, 

Lisa Chamberlain-James, Paolo Morelli, Roger Pickett, Gregory 

A. Poland, Thomas M. Schindler, and Amy Whereat for their 

review, insights into further actions, and encouragement.  

6. APPENDICES
Appendix I: Reviewers’ checklist

7. REFERENCES
1. Rennie D, Flanagin A. Three decades of peer review congresses. JAMA - J 

Am Med Assoc. 2018;319(4):350-353. doi:10.1001/jama.2017.20606

2. Palayew A, Norgaard O, Safreed-Harmon K, Andersen TH, Rasmussen LN, 

Lazarus JV. Pandemic publishing poses a new COVID-19 challenge. 

Nat Hum Behav. 2020;4(7):666-669. doi:10.1038/s41562-020-0911-0

3. Mehra MR, Desai SS, Ruschitzka F, Patel AN. RETRACTED: 

Hydroxychloroquine or chloroquine with or without a macrolide for 

treatment of COVID-19: a multinational registry analysis. Lancet. 

2020;0(0). doi:10.1016/S0140-6736(20)31180-6

4. Mehra MR, Desai SS, Kuy S, Henry TD, Patel AN. Cardiovascular disease, 

drug therapy, and mortality in Covid-19. N Engl J Med. 2020;382(25):e102. 

doi:10.1056/NEJMoa2007621

5. AMWA-EMWA-ISMPP joint position statement on the role of professional 

medical writers. 2017. Accessed November 27, 2017. http://journal. 

emwa.org/writing-better/amwa-emwa-ismpp-joint-position-statement-

on-the-role-of-professional-medical-writers

6. bioRxiv. Advancing the sharing of research results for the life sciences. 

bioRxiv. Accessed September 21, 2020. https://www.biorxiv.org/about-

biorxiv

7. medRxiv. Submit your article to bioRxiv, an online archive and 

distribution service for preprints in the life sciences. medRxiv. Accessed 

September 21, 2020. https://www.biorxiv.org/submit-a-manuscript

8. Preprints.org. Preprints.org: How it works. preprints.org. Accessed 

September 21, 2020. https://www.preprints.org/how_it_works#screen 

9. Levchenko M. Preprints in Europe PMC: Reducing friction for 

discoverability. Europe PMC. Accessed September 21, 2020. http://blog. 

europepmc.org/2018/07/preprints.html

10. Iwema CL, LaDue J, Zack A, Chattopadhyay A. search.bioPreprint: A 

discovery tool for cutting edge, preprint biomedical research articles 

[version 2; referees: 2 approved]. F1000Research. 2016;5. doi:10.12688/

F1000RESEARCH.8798.2

11. Abdill RJ, Blekhman R. Tracking the popularity and outcomes of all 

bioRxiv preprints. Elife. 2019;8. doi:10.7554/eLife.45133

12. Fraser N, Momeni F, Mayr P, Peters I. The relationship between bioRxiv 

preprints, citations and altmetrics. Quant Sci Stud. April 2020:1-21. 

doi:10.1162/qss_a_00043

13. Gertel A. The data economy | Rush to publication – What do we have to 

lose? Med Writ. 2020;29(2). Accessed September 21, 2020. https://journal. 

emwa.org/the-data-economy/rush-to-publication-what-do-we-have- 

to-lose 

14. Maslove DM. Medical preprints – a debate worth having. JAMA - J Am 

Med Assoc. 2018;319(5):443-444. doi:10.1001/jama.2017.17566

15. Penfold NC, Polka JK. Technical and social issues influencing the 

adoption of preprints in the life sciences. Shafee T, ed. PLOS Genet. 

2020;16(4):e1008565. doi:10.1371/journal.pgen.1008565

16. F1000Research. About F1000Research | How it works | Beyond a research 

journal. F1000Research. Accessed September 21, 2020. 

https://f1000research.com/about 

17. Wiley. Catheterization and cardiovascular interventions. Author 

Guidelines. Wiley. Accessed September 21, 2020. https://onlinelibrary. 

wiley.com/page/journal/1522726x/homepage/forauthors.html 

18. Bell GP, Kvajo M. Tackling waste in publishing through portable peer 

review. BMC Biol. 2018;16(1):146. doi:10.1186/s12915-018-0619-z

19. Taylor & Francis. Article transfers - Author services. Taylor & Francis. 

Accessed September 21, 2020. https://authorservices.taylorandfrancis. 

com/peer-review/transfers 

20. Wiley. Free format submission. Wiley. Accessed September 21, 2020. 

https://authorservices.wiley.com/author-resources/Journal-Authors/

Prepare/free-format-submission.html 

21. Tennant JP, Ross-Hellauer T. The limitations to our understanding of peer 

review. Res Integr Peer Rev. 2020;5(1):6. doi:10.1186/s41073-020-00092-1

22. Battisti WP, Wager E, Baltzer L, et al. Good publication practice for 

communicating company-sponsored medical research: GPP3. Ann Intern 

Med. 2015;163(6):461-464. doi:10.7326/M15-0288
continued on page 63

http://journal.emwa.org/writing-better/amwa-emwa-ismpp-joint-position-statement-on-the-role-of-professional-medical-writers
https://www.biorxiv.org/about-biorxiv
https://www.biorxiv.org/submit-a-manuscript
https://www.preprints.org/how_it_works#screen
http://blog.europepmc.org/2018/07/preprints.html
https://journal.emwa.org/the-data-economy/rush-to-publication-what-do-we-have-to-lose
https://f1000research.com/about
https://onlinelibrary.wiley.com/page/journal/1522726x/homepage/forauthors.html
https://authorservices.taylorandfrancis.com/peer-review/transfers
https://authorservices.wiley.com/author-resources/Journal-Authors/Prepare/free-format-submission.html


62    AMWA Journal / V36 N2 / 2021 / amwa.org        

REVIEWERS’ CHECKLIST 
This checklist is intended to be used by journals. However, it can also guide authors and medical writers in their review of manuscripts before submission.  
 The checks should be performed by a suitably qualified team, preferably consisting of editors, subject matter experts (ie, peer reviewers; not required 
for preprints), medical writers, statisticians, and trained researchers. The review team should comprise at least two reviewers.  
 Not every reviewer is required to complete all fields, but all items need to be checked by at least one accountable reviewer. 

Item

Medical 
Writer  

Reviewer

Clinical 
Reviewer

Biostatistical 
Reviewer

Peer 
Reviewer  

A

Peer 
Reviewer  

B

Source documents (if available and required by journal)

Clinical Study Protocol 

Redacted Clinical Study Report Synopsis

Statistical Analysis Plan 

Tables/Listings/Graphs 

Attestations

Data sharing statement (ICMJE template)

Author contribution forma

Signed author forms confirming that the authors had full  
access to the data reported in the article and accept responsibility for  
submitting the articleb

Author confirmation that verified data were used to develop the manuscript

Conflict of interest statement (ICMJE template recommended)

List of sources of funding for the study and any supporting activities

Suggested Checks for Preprint Editorial Review

Manuscript contains no offensive or nonscientific content

No material is plagiarized

Basics of the statistical methods are sound (eg, adequacy of analysis  
population, adequate handling of missing data)

End points and inclusion/exclusion criteria are in alignment with the study 
registration on a publicly available registry (eg, ClinicalTrials.gov), provided 
this is required. For primary reports of clinical trials, all end points are  
mentioned in the results section.

Content is consistent and clear across each section of the manuscript (eg, 
information in abstract matches results, hypothesis posed in introduction is 
addressed in discussion)

Discussion points and conclusions are supported by the reported data

Adherence to guidelines (eg, CONSORT, STROBE, PRISMA, SPIRIT, CARE)

Specify guideline(s):______________________

No ethical concerns

Additional Checks for Peer Review

Further statistical considerations: 
- adequacy of sample size calculation (eg, adequate comparator) 
- adequacy of statistical methods 
- check for random errors 
- sources of bias addressed

Methodological qualityc 

- confounding influences (eg, concomitant treatments) 
- inadequate disclosure of information 
- misinterpretation

Study designb 

- adequacy and relevance of endpoints 
- adequacy of inclusion/exclusion criteria 
- blinding 
- adequacy of follow-up period 
- adequacy of reporting complications 
- adequacy of data presentation

aShould include a question if medical writing support was used. 
bMay be merged with author contribution form. 
cAdapted from MEDDEV 2.7/1; alternatively, other criteria can be used to appraise the manuscript (eg, https://libguides.napier.ac.uk/litrev/critapp). 
Additional columns and signature lines can be added as needed.

https://libguides.napier.ac.uk/litrev/critapp


      AMWA Journal / V36 N2 / 2021 / amwa.org    63

23.  ICMJE. Recommendations for the conduct, reporting, editing, 

and publication of scholarly work in medical journals. ICMJE. 

2019. Accessed September 21, 2020. http://www.icmje.org/

recommendations

24.  Matcham J, Julious S, Pyke S, et al. Proposed best practice for 

statisticians in the reporting and publication of pharmaceutical 

industry-sponsored clinical trials. Pharm Stat. 10(1):70-73. 

doi:10.1002/pst.417

25.  Ethical guidelines for peer reviewers (English) | COPE: Committee 

on publication ethics. doi:10.24318/cope.2019.1.9

26.  The editors of the Lancet Group. Learning from a retraction. 

Lancet. 2020;396(10257):1056. doi:10.1016/S0140-6736(20)31958-9

27.  Jacobs A. Adherence to the CONSORT guideline in papers written 

by professional medical writers. Med Writ. 2010;19(3):196-200.

28.  Gattrell WT, Hopewell S, Young K, et al. Professional medical 

writing support and the quality of randomised controlled trial 

reporting: a cross-sectional study. BMJ Open. 2016;6(2):e010329. 

doi:10.1136/bmjopen-2015-010329

29.  Bailey M. Science editing and its effect on manuscript acceptance 

time. J Am Med Writ Assoc. 2011;26:147-152.

30.  Hamilton CW, Gertel A, Jacobs A, Marchington J, Weaver S, 

Woolley K. Mythbusting medical writing: Goodbye ghosts, hello 

help. Account Res. 2016;23(3):178-194. doi:10.1080/08989621. 

2015.1088788

31.  Woolley KL, Ely JA, Woolley MJ, et al. Declaration of medical 

writing assistance in international, peer-reviewed publications 

and effect of pharmaceutical sponsorship. Fifth Int Congr Peer 

Rev Biomed Publ Chicago. 2006;296(8):932-934. doi:10.1001/

jama.296.8.932-b

32.  Breugelmans R, Barron JP. The role of in-house medical 

communications centers in medical institutions in nonnative 

English-speaking countries. Chest. 2008;134(4):883-885. 

doi:10.1378/chest.08-1068

33.  Manring MMM, Panzo JA, Mayerson JL. A framework for 

improving resident research participation and scholarly output. J 

Surg Educ. 2014;71(1):8-13. doi:10.1016/j.jsurg.2013.07.011

34.  Woolley KL, Lew RA, Stretton S, et al. Lack of involvement of 

medical writers and the pharmaceutical industry in publications 

retracted for misconduct: a systematic, controlled, retrospective 

study. Curr Med Res Opin. 2011;27(6):1175-1182. doi:10.1185/0300

7995.2011.573546

35.  Chipperfield L, Citrome L, Clark J, et al. Authors’ submission 

toolkit: a practical guide to getting your research published.  

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2010.499344

36.  The EQUATOR network | Enhancing the QUAlity and transparency 

of health research. Accessed September 21, 2020. https://www.

equator-network.org

DIA 
June 27 to July 1, 2021
Virtual
https://www.diaglobal.org/Flagship/DIA-2021

Regulatory Affairs Professionals Society
September 12-15, 2021
Virtual
https://www.raps.org/regulatory-convergence
 
National Association of Science Writers
October 8-11, 2021
Boulder, Colorado, and Virtual
https://www.nasw.org/events/sciencewriters2021

International Society of Managing and  
Technical Editors
October 11-14, 2021
Virtual
https://www.ismte.org/page/Conferences

International Conference on Communication in 
Healthcare
October 17-20, 2021
Virtual
https://achonline.org/ICCH2021

American Public Health Association
October 24-27, 2021
Denver, Colorado, and Virtual
https://www.apha.org/events-and-meetings/annual

AMWA Medical Writing & Communication Conference
October 27-29, 2021
Virtual
www.amwa.org/conference

Association of Health Care Journalists 
October 28-31, 2021
Austin, TX
https://healthjournalism.org/calendar-details.php?id=2245

European Medical Writers Association
November 4-6, 2021
Cascais, Portugal
https://www.emwa.org/conferences/future-conferences/

CALENDAR OF MEETINGS
Please confirm with individual meeting hosts

www.amwa.org/conference

2021
AMWA

Medical Writing &
Communication
Conference
OCTOBER 27-29, 2021
Coming to a device near you

Trends and Opportunities for Medical Communicators

continued from page 61




