International Society For 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.

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...

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.

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