Medical Publication Professionals Research Articles

Good Publication Practice (GPP) 2022 Update: An Interview with Dikran Toroser

Dikran Toroser was educated in the UK and has a PhD in Biochemistry from Newcastle University in Newcastle upon Tyne. He did his post-doctoral research in the UK at the Cambridge lab on genetics and then moved to the US to work as a biochemist 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 scientific publication teams involved with pre-clinical, 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 professional organizations such as American Medical Writers Association (AMWA) and International Society for Medical Publication Professionals (ISMPP), Dikran most recently has been involved in compiling guidelines for the 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) guidelines for company-sponsored biomedical research2.

AMWA, EMWA, and ISMPP Promote Ethical, Professional Medical Writing in JAMA Oncology Letter to the Editor

In March 2021, Del Paggio et al. published an article in JAMA Oncology that included disparaging comments about medical writers. American Medical Writers Association (AMWA) leaders, in partnership with representatives from the European Medical Writers Association (EMWA) and the International Society for Medical Publication Professionals (ISMPP), immediately and swiftly drafted and submitted a letter of response to this article, which was published on August 26, 2021, along with 2 other letters and the authors‘ response to all 3 letters. Del Paggio et al.’s article reported on multiple aspects of randomized clinical trials in oncology, including the use of professional medical writers. Specifically, the authors stated, “There is reason to be concerned that medical writers may unduly influence the interpretation of trials, … as it is unlikely that medical writers have a neutral effect on the clinical trial reporting.” Although we all share an understanding of the value of medical writers, it is imperative that we respond publicly to these attacks to safeguard the reputation of our profession. As highlighted in our letter, the use of our profession’s expertise improves accuracy, timeliness, and adherence to ethical conduct. Evidence from independent research on the benefits of working with medical writers was included in the response. The commitment of medical writers to adhere to Good Publication Practice (GPP3) guidelines and to ethical principles in scientific publishing as well as to the professional codes of conduct of their professional organizations was also identified as a significant benefit of working with professional medical writers.

Digital Enhancements for Primary Medical Manuscripts: A Survey on Perceptions, Challenges, and Needs of Medical Publication Professionals

Given their potential for engaging audiences, there has been increasing interest recently in the use of digital enhancements, such as video abstracts and infographics, for primary publications in peer-reviewed medical journals. However, their uptake by authors and sponsors of medical publications has been mixed, with few top journals offering the possibility of publishing digital enhancements beyond supporting slides and lay summaries. Digital enhancements for primary manuscripts may provide new opportunities for medical writers to expand their skills and services, but it is unclear whether medical writers receive and accept requests to develop digital enhancements regularly and what training they need to generate high-quality deliverables for their clients. Understanding the perspectives of medical publication professionals and their clients on digital enhancements for peer-reviewed journals may help address misconceptions and concerns and identify more effective ways to create auxiliary digital content to support the dissemination of research findings. Here, a survey was conducted to gauge the overall interest in accompanying digital enhancements among medical publication professionals and their perception of their clients’ needs, determine the perceived value of these features, and identify barriers in development. The survey was created and posted on AMWA Engage, AMWA New England Chapter E-News, LinkedIn, and the MedComms Networking webpage. A total of 116 respondents completed the survey. About half had developed digital enhancements for primary publications, mostly for pharmaceutical companies, medical communication agencies, and other nonacademic organizations. Infographics and visual abstracts were the most frequently requested type of enhanced content. Although the respondents recognized the importance of digital enhancements to facilitate data visualization, approximately half reported not having specific training or experience to enable them to accept such assignments. For their clients, the main reasons given for not developing digital enhancements were cost and time constraints, lack of interest, and author unavailability.

Multiple Voices on Authorship and Authority in Biomedical Publications

The intersection of industry sponsorship, government regulation, academic interests, and medical journals is a core interest in biomedical research, and one that overlaps with concerns in the rhetoric of health and medicine (RHM). At stake in conversations about this intersection are authority and participation: who is and is not invited to offer opinions and, even when invited, whose opinions are taken seriously. Following, colleagues with ties to the International Society of Medical Publication Professionals (ISMPP) present their ideas in response to questions about authorship and authority posed by another, who is also an RHM scholar. The answers of medical journal editors and publications professionals employed by corporate entities largely align with the view that both authorship and authority should be determined by scientific practice and knowledge rather than power relations or politics. A philosopher who gave an invited plenary talk at the national ISMPP meeting and participated in the organization’s first white paper offers a different perspective, considering the ways that fields self-constitute in part by bounding authority and authorship.

Challenges and growth opportunities: the landscape of Chinese medical publication professionals in the global context: a questionnaire-based survey

Objective The Chinese healthcare industry has immense potential for innovation and requires competent publication professionals for global reach. Changes in regulatory landscape of China necessitates pharmaceutical industries to collaborate with medical professionals who are capable of keeping up with both changes in regulations and innovative medicine. Methods We initiated an online questionnaire-based survey via WeChat from August 3 to August 14, 2019 which focused on experience level, challenges, career development, and training requirements of survey participants. Results A total of 53 medical publication professionals participated in this survey. Contrary to global trends, 77% of participants had <5 years of professional experience in publication, although only 36% of participants had <5 years of experience in healthcare industry. In all, 63% of respondents spent <50% of their time in publication-related activities, contributing to <10 manuscripts per year. Their expertise in manuscripts spanned clinical studies (68%), post-marketing studies (62%), and reviews (38%). Poor research design and data quality, limited medical writing skill, and inefficient communication with authors were major challenges for developing high-quality publications. Awareness of good publication practices guidelines was high (49%) and 15% of respondents were Certified Medical Publication Professionals. Strategic publication planning (72%), industry trends (66%), and best practices (55%) were some of training requirements identified to increase competencies among respondents. Conclusions Although the Chinese medical publication professional industry is at a nascent stage, an attempt is being made to provide opportunities for its publication professionals to develop their competencies to match global standards.

A Letter from ISMPP

PrefaceDear Colleagues,The 15th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP), Communicating Science in an Era of Innovation and Change, took place 15–17...

Peers in Review: Introducing ISMPP, a Society for Medical Publication Professionals

Peers in Review: Introducing ISMPP, a Society for Medical Publication Professionals

Ipratropium/Salbutamol Comparator Versus Originator for Chronic Obstructive Pulmonary Disease Exacerbations: USA Observational Cohort Study Using the Clinformatics™ Health Claims Database

Acknowledgements The authors wish to thank Priyanka Raju Konduru of Observational and Pragmatic Research Institute Pte Ltd (OPRI) for assistance with data extraction. This study was sponsored and funded by Teva Branded Pharmaceutical Products, R&D, Inc. Lynanne McGuire, PhD, of MedVal Scientific Information Services, LLC (Princeton, NJ, USA) provided medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals’ ‘Good Publication Practice for Communicating Company-Sponsored Medical Research: the GPP3 Guidelines.’ Funding to support medical writing assistance was provided to MedVal by Teva Branded Pharmaceutical Products R&D, Inc., Frazer, PA, USA. Teva provided a full review of the article and provided funding of the journal’s article processing charges. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval to the version to be published. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

High nonpublication rate from publication professionals hinders evidence-based publication practices.

Background. The need for timely, ethical, and high-quality reporting of clinical trial results has seen a rise in demand for publication professionals. These publication experts, who are not ghostwriters, work with leading medical researchers and funders around the world to plan and prepare thousands of publications each year. Despite the involvement of publication professionals in an increasing number of peer-reviewed publications, especially those that affect patient care, there is limited evidence-based guidance in the peer-reviewed literature on their publication practices. Similar to the push for editors and the peer-review community to conduct and publish research on publication ethics and the peer-review process, the International Society for Medical Publication Professionals (ISMPP) has encouraged members to conduct and publish research on publication planning and practices. Our primary objective was to investigate the publication rate of research presented at ISMPP Annual Meetings.Methods. ISMPP Annual Meeting abstract lists (April 2009–April 2014) were searched in November 2014 and data were extracted into a pilot-tested spreadsheet. MEDLINE was searched in December 2014 to determine the publication rate (calculated as the % of presented abstracts published as full papers in peer-reviewed journals). Data were analyzed using the Cochran-Armitage trend test (significance: P < .05) by an independent academic statistician.Results. From 2009 to 2014, there were 220 abstracts submitted, 185 accepted, and 164 presented. There were four corresponding publications (publication rate 2.4%). Over time, ISMPP’s abstract acceptance rate (overall: 84.1%) did not change, but the number of abstracts presented increased significantly (P = .02). Most abstracts were presented as posters (81.1%) and most research was observational (72.6%). Most researchers came from the US (78.0%), followed by Europe (17.7%), and the Asia-Pacific region (11.2%).Discussion. Research presented at ISMPP Annual Meetings has rarely been published in peer-reviewed journals. The high rate of nonpublication by publication professionals has now been quantified and is of concern. Publication professionals should do more to contribute to evidence-based publication practices, including, and especially, their own. Unless the barriers to publication are identified and addressed, the practices of publication professionals, which affect thousands of peer-reviewed publications each year, will remain hidden and unproven.

For the greater good…Can agency competitors cooperate to advance medical publication practices?

The business of medical writing is competitive, but can it be cooperative? Is it time for agencies, which provide professional and ethical publication support to authors, to cooperate for the greater good of the medical publication profession? Formal collaborations have occurred among competitors in the biopharmaceutical and the contract research organisation sectors but rarely among competitors in the medical communications sector. In holding the inaugural Agency Executive Forum, sponsored by the International Society for Medical Publication Professionals (ISMPP), representatives of nine large international agencies met to rectify this situation. We identified a number of areas where we might cooperate, including proposing best-practices for working with freelance medical writers and for responding to procurement-driven requests for information. We are actively looking to cooperate with other groups, such as EMWA, to help ensure outputs that are valuable to the relevant stakeholders.

Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey

ObjectiveTo gather information about current practices and implementation of publication guidelines among publication professionals working in or for the pharmaceutical industry.Design/settingWeb-based survey publicised via email and social media to members...

A decade of change: A new ISMPP has arrived

Founded originally as a not-for-profit society to provide education, advocacy, and best practices for those involved in medical publication planning, the International Society for Medical Publication Professionals (ISMPP) has grown in size to over 1300 members throughout the world. As ISMPP approaches its 10th Annual Meeting, significant changes are occurring within the industry, as well as in the organisation's operating structure, including the hiring of a full-time President and Chief Operating Officer to help drive the vision and mission of the organisation and provide a ‘visible’ face to ISMPP. Additional changes include a reassessment of key elements of ISMPP's vision and mission, increased organisational collaborations, and more proactive positions across numerous areas of interest in support of its members. At the same time there are significant concerns across the industry regarding initiatives that undermine the credibility and intrinsic value all publication professionals hold dear, which is transparent and ethical scientific exchange.

Erratum

Erratum Levine T. Treating refractory dermatomyositis or polymyositis with adrenocorticotropic hormone gel: a retrospective case series. Drug Des Devel Ther. 2012;6:133–139. The journal should have included the submitted complete disclosure statement in the published article. The correct text is as follows:AcknowledgmentsThe author would like to thank Lynanne McGuire, PhD, of MedVal Scientific Information Services, LLC, for providing medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals’ Good Publication Practice for Communicating Company-Sponsored Medical Research: The GPP2 Guidelines.DisclosureDr Levine is a consultant for Questcor Pharmaceuticals, Inc. Funding to support the preparation of this manuscript was provided by Questcor Pharmaceuticals, Inc.

Ten Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research: A Joint Journal and Pharmaceutical Industry Perspective

The credibility of industry-sponsored clinical research has suffered in recent years, undercut by reports of selective or biased disclosure of research results, ghostwriting and guest authorship, and inaccurate or incomplete reporting of potential conflicts of interest.1,2 In response, many pharmaceutical companies have integrated best practices and recommendations from groups such as the International Committee of Medical Journal Editors (ICMJE), the Good Publication Practice guidelines, the Committee on Publication Ethics, the EQUATOR (Enhancing the QUAlity and Transparency Of health Resources) Network, and the Medical Publishing Insights and Practices (MPIP) initiative into their internal policies and standard operating procedures.3-10 However, a credibility gap remains: some observers, including some journal editors and academic reviewers, maintain a persistent negative view of industry-sponsored studies.11 Given industry's pivotal role in the development of new therapies, further improvements in research conduct and disclosure are needed across the industry-investigator-editor enterprise to restore confidence in industry-sponsored biomedical research. In 2008, the MPIP was founded by members of the pharmaceutical industry and the International Society for Medical Publication Professionals to elevate trust, transparency, and integrity in publishing industry–sponsored studies through education and creation of a discussion forum among industry research sponsors and biomedical journals.12,13 In 2010, the MPIP convened a roundtable of 23 journal editors and industry representatives (see the “Acknowledgments” section for a list of MPIP participants) to characterize the persistent and perceived credibility gap in industry-sponsored research and identify approaches to resolve it. Attendees agreed that there have been important improvements in the conduct and reporting of industry-sponsored studies during the past 5 years, but several opportunities remain for additional improvement. Attendees reached consensus on a top 10 list of recommendations (Table), intended to serve as a call to action for all stakeholders—authors, journal editors, research sponsors, and others—to enhance the quality and transparency of industry-sponsored clinical research reporting. Although framed in the context of industry sponsorship, many of these recommendations would enhance the credibility of clinical research publications in general, regardless of the funding source. TABLE Top 10 Recommendations for Closing the Credibility Gap in Reporting Industry-Sponsored Clinical Research

Authors' Submission Toolkit: A practical guide to getting your research published

Biomedical journals and the pharmaceutical industry share the goals of enhancing transparency and expanding access to peer-reviewed research; both industries have recently instituted new policies and guidelines to effect this change. However, while increasing transparency may elevate standards and bring benefits to readers, it will drive a significant increase in manuscript volume, posing challenges to both the journals and industry sponsors. As a result, there is a need to: (1) increase efficiency in the submission process to accommodate the rising manuscript volume and reduce the resource demands on journals, peer reviewers, and authors; and (2) identify suitable venues to publish this research. These shared goals can only be accomplished through close collaboration among stakeholders in the process.In an effort to foster mutual collaboration, members of the pharmaceutical industry and the International Society for Medical Publication Professionals founded a unique collaborative venture in 2008 - the Medical Publishing Insights and Practices initiative (MPIP). At an MPIP roundtable meeting in September 2009,journal editors, publishers and industry representatives identified and prioritized opportunities to streamline the submission process and requirements, and to support prompt publication and dissemination of clinical trial results in the face of increasing manuscript volume. Journal and sponsor participants agreed that more author education on manuscript preparation and submission was needed to increase efficiency and enhance quality and transparency in the publication of industry-sponsored research. They suggested an authors'guide to help bridge the gap between author practices and editor expectations.To address this unmet educational need, MPIP supported development of an Authors' Submission Toolkit to compile best practices in the preparation and submission of manuscripts describing sponsored research.The Toolkit represents a unique collaboration between the pharmaceutical industry and biomedical journals,and reflects both groups' perspectives on how authors can help raise standards and increase efficiency in publishing industry-sponsored studies. The information provided in the toolkit can be useful to help authors navigate the manuscript

Disclosures: What do they mean for Nurse Authors and Editors?

Disclosures: What do they mean for Nurse Authors and Editors?

Conflicts of interest, authorship, and disclosures in industry-related scientific publications: the tort bar and editorial oversight of medical journals.

Conflicts of interest, authorship, and disclosures in industry-related scientific publications: the tort bar and editorial oversight of medical journals.

Defining professionalism in medical publications: transparency, objectivity and ethics

Online SummaryThis supplement features 15 abstracts selected (via a peer-review process) from those presented at the 5th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP) - Defining Professionalism in Medical Publications: Transparency, Objectivity, and Ethics, April 20-22, 2009, Philadelphia, PA, USA:Public website disclosure of corporate publication policies and procedures among pharmaceutical companies; How clear is transparent? A content analysis of transparency statements used within medical and scientific peer-review publications; Benchmarking medical publication policies, procedures, and practices across pharmaceutical companies; Public availability of pharma policies on their role in peer-reviewed publications; Observations on shifting preferences for planning, writing, and management of scientific publications; The role of medical publications in determining access, coverage, and reimbursement policy for health plans; Achieving best practice: benefits of an electronic publications planning tool; Review of online publication policies: pharmaceutical companies and medical colleges; A survey of accredited US medical school policies regarding collaboration with industry on secondary publications; Beliefs of US KOLs regarding professionalism in pharmaceutical company-sponsored medical publications;Evidence-based approach to publication planning; Strengthening the collaboration between authors and publication planners: recommendations from a publications advisory board; A survey of medical journals' acceptance of the role of professional medical writers in peer-reviewed publications; Development of clinically impactful, scientifically relevant and wholly transparent academic publications: an 8-step, best-practices approach to quality and compliance; Clinical trial data disclosure: impact on publication policies and disposition

American Medical Writers Association Website Review

Are you missing out on a great resource for medical communicators? If you've never visited the the American Medical Writers (AMWA) website (www.amwa.org), the answer is yes! Whether you're an author, editor, or involved in any other aspect of medical communications, you'll find helpful resources on the AMWA site. The links are fun to explore and include allied organizations such as AMWA's European cousin EMWA, and the International Society for Medical Publication Professionals. Numerous guidelines and statements about the ethics of writing and publishing are available, creating an easy one-stop area for policy statements and ethical guidelines. Wonderful library resources await you, too. There's an amazing journal locator called Genamics/Journalseek at http://journalseek.net/med.htm. This database includes over 94,000 categorized titles, so finding the journal that might be the perfect fit for your proposed manuscript just got a little easier. You'll also find standard government resources such as Medline and FirstGov, plus a long list of specific medical writing resources, including online dictionaries and a long list of free medical journals. I guarantee you'll find at least one link that's so intriguing it will capture your attention and distract you from whatever other project you may have been working on when you clicked into the site! During the first part of the 1990s, my association with AMWA was synchronous and in-person at the yearly conferences. I began attending in order to find resources to help in developing manuscripts. Not only did I find more resources than I expected, but the collegial, interdisciplinary interactions expanded my myopic (i.e. “nursing focused”) view of the world beyond what I ever thought possible. The expansion was occasionally frightening as I signed up for continuing education with titles like “Sentence Structure and Patterns,” and “Punctuation for Clarity and Style,” thinking I would be publicly humiliated by my ignorance. At the end of the courses, I was amazed that 3 hours spent working with sentences and/or paragraphs had actually been fun, engaging, and completely comprehensible! The opportunities which were made available to me because of my association with AMWA have enriched my nursing career immeasurably. Happy exploring! Diane B. Monsivais PhD(c), CRRN, MSN is on the faculty at the University of Texas El Paso School of Nursing and a doctoral candidate at the University of Texas Houston.