What is good publication practice, what is ISMPP, and why you should care

As a clinician, I want to read journal articles that are relevant, thoughtful and reasonably complete. There are many resources available that will assist authors in producing manuscripts that fit the educational needs of their audience as well as add to the body of biomedical literature so that other colleagues may build upon this work. These resources include books, as for example Hall's concise ‘How to Write a Paper’ now in its fifth edition 1, and an extensive set of guidelines catalogued at the website of the Enhancing the QUAlity and Transparency Of health Research network (http://www.equator-network.org/). Industry-sponsored studies face special challenges, including additional scrutiny because of perceived biases, whether deserved or not 2. A call for greater transparency and the publication of all results, good, bad, or neutral, has created additional pressure to get these articles out in a timely manner. Professional medical writers have often been employed to assist in getting this job done in an efficient and quality manner. The International Society for Medical Publication Professionals (ISMPP) is a not-for-profit organisation founded in 2005 by medical publication professionals. ISMPP has more than 1500 members with representation from all stakeholders involved in the publication of medical research, including pharmaceutical, biotechnology, and device companies, medical publications and communications agencies, medical journal publishers and editors, and professional medical writers (http://www.ismpp.org/). ISMPP's mission statement is ‘Advance the medical publication profession globally through standards and best practices, education, advocacy, and professional collaboration.’ ISMPP has a Code of Ethics and a certification programme (Certified Medical Publication Professional, or CMPP) that confirms by examination expertise as a medical publication professional, with proficiency in good publication practices, commitment to ethical and transparent data dissemination standards, and leadership in upholding and fostering integrity and excellence in medical publication. Once earned, the CMPP credential is valid for 5 years, at the expiration of which certificants must recertify. In addition, those earning this credential must agree to a Code of Conduct which outlines appropriate and expected standards of professional behaviour. ISMPP holds annual meetings in the USA and the EU, broadcasts monthly webinars (ISMPP U), and recently has reached out to the Asia-Pacific region to provide webinars of special interest and hold live educational seminars. ISMPP also partners with related professional organisations such as the American Medical Writers Association, European Medical Writers Association, and with industry societies. Prior to ISMPP, the landmark guidelines on Good Publication Practice (GPP) were developed with the aim of ensuring that ‘clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner’ 3. To address legislative, guidance, and ethical developments since 2003, and to reinforce the aims of the 2003 GPP publication, ISMPP convened a Steering Committee to develop a revised GPP document, which is now known as GPP2 4, whose first author was the former Publisher of the International Journal of Clinical Practice, and who made a persuasive argument that I should join ISMPP in my role with the journal. GPP2 provided guidance on the roles of authors, sponsors, and other contributors, reimbursement and honoraria, how to establish a publication steering committee, role of professional medical writers, and recommendations for publication planning and documentation. Additional guidance for clinician researchers, other scientists, and professional medical writers regarding the production and submission of manuscripts has been spearheaded by projects such as the Medical Publishing Insights and Practices initiative (MPIP), involving journal editors, publishers, and industry representatives 5. On 11 August 2015, GPP3, the newest iteration of Good Publication Practice, was published 6. GPP3 expands upon the core values of GPP and GPP2: integrity, completeness, transparency, accountability, and responsibility, and contains new elements regarding data sharing and expanded information on the evidence base on the role of medical writers. The GPP3 steering committee was diverse, with representation from professional medical writers, the biomedical device and pharmaceutical industry, medical communication companies, and journal editors and publishers. Representation was also global, with participants from the US, UK, Netherlands, Denmark, Australia/New Zealand, and Japan. Several subcommittees worked on different sections of the document. Over 90 reviewers provided comments. In the end, efforts were made to reorganise content for increased clarity and to reduce redundancy, and additional examples provided throughout to help clarify ‘grey’ areas. New areas include an emphasis placed on the need to include trial registration numbers in all publications and presentations, including secondary publications. Plagiarism, including self-plagiarism is discussed. There is a discussion surrounding honoraria and reimbursement to help clarify when payment may be appropriate. The new International Committee of Medical Journal Editors (ICMJE) criteria for authorship is outlined and two new tables were added that provide guidance and interpretation to common authorship issues, including number of authors, sequence, addition or removal, and incapacity or death of an author. Additional clarity is provided on what constitutes ghost or guest authorship. The term ‘Disclosures’ is now preferred to ‘Conflicts of Interest’ or ‘Competing Interests’, as these latter terms may imply actual (rather than perceived or potential) conflicts and may inadvertently prevent full disclosure if the author(s) interpret ‘Conflicts of Interest’ or ‘Competing Interests’ narrowly, or fail to consider other relationships that may affect the manuscript. Next steps for GPP3 include global dissemination at local, national, and international meetings, and setting up and operating a GPP3 Website with training materials, FAQs and a checklist tool. Translations of GPP3 into Japanese and Chinese are also anticipated. In this issue of the International Journal of Clinical Practice, DeTora et al. share their perspective on publication planning 7. Important points are raised regarding the importance of a well-organised plan so that research and results are clearly and ethically communicated to scientific and healthcare communities, as well as the public. Key areas of attention include authorship, contributorship, and acknowledgements, making data available, and avoiding duplicate, redundant or selective publication. A new area is the reporting of ‘transfers of value’, a requirement of the US Physician Payments Sunshine Act. The Sunshine Act mandates pharmaceutical and device manufacturers to enumerate certain payments and items of value given to physicians and teaching hospitals, including the cost of expediting the preparation and publication of industry-sponsored journal articles with the use of outside editorial assistance 8. Dr Teresa L. Peña, Chair, ISMPP Board of Trustees, said it best with ‘A call to action is needed for medical publications and communications agencies, medical journal publishers, editors and reviewers, researchers and professional medical writers to better streamline scientific exchange without compromising quality, ethics and transparency. More seamless cooperation and effective teamwork with regulators, investigators and patients are needed to build trust in medical research. Thus, to foster the expedited development of more robust, high-quality and clinically relevant publications in medical research, the goal remains to simplify the publication development process and expand medical publication education so that it can be made more methodical and have broader reach, with the end goal of speeding up patient access to new medicines. However fast the pace, as medical publication professionals, we must not fail to educate and create appropriate pressures to deliver our research with ethics and integrity.’ 9 No external funding or writing assistance was utilised in the production of this editorial. Leslie Citrome is a member of International Society for Medical Publication Professionals and is a co-author of the updated Good Publication Practice guidelines. In the past 36 months Leslie Citrome has engaged in collaborative research with, or received consulting or speaking fees, from: Alexza, Alkermes, Allergan, AstraZeneca, Avanir, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Forest, Forum, Genentech, Janssen, Jazz, Lundbeck, Merck, Medivation, Mylan, Novartis, Noven, Otsuka, Pfizer, Reckitt Benckiser, Reviva, Shire, Sunovion, Takeda, Teva and Valeant.