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Over the past eight decades, the role and perceived value of what we’ve come to know as the medical writer has evolved. As the process of document production became more complicated and time-consuming, a separate group of specialists evolved to serve the role of “medical writer.” Although this role may not have been formally defined, and certainly not consistently so, this was the genesis of the professional we consider to be the medical writer. In preparing for this special topics edition of the AMWA Journal, I wanted to tap into a broad and varied spectrum of those who practice the trade of professional medical writing as well as some who collaborate with them. In eliciting thoughts, I decided to create a series of virtual panels, thus allowing for a more conversational and interactive experience among participants. What has resulted is a series of collective thoughts on where the profession is going, and which forces will shape the context within which we will ply our trade going forward. In one case, individuals formed their own “panel of one”; however, panels mostly comprised colleagues either from the same company or those who were invited because they were members of a particular professional organization (eg, the Drug Information Association (DIA)) or represented a particular viewpoint within the medical writing community.

There is a growing concern within the US Food and Drug Administration (FDA) and the pharmaceutical/biotechnology communities about state-based initiatives to provide access to drugs that are in the early stages of development. These legislative bills allow a patient to circumvent the protections afforded by regulated procedures as embodied in FDA regulation and guidance. Over the course of more than 80 years, the latter have served to best ensure the safety and therapeutic efficacy of new medicines and have evolved into an effective set of protections of human privacy, dignity, and fairness. To undermine these longstanding principles may have consequences which we, as society, must be prepared to address. This article examines the dynamic tensions that exist between the perceived best interests of the individual patient, the patient community, legislators, regulators, physicians, and the society at large. Decisions have consequences and, too often, these fail to be considered in the process of choosing the pathway that, in a context fraught with uncertainty, best meets a desperate need.

The editorial by Roger Collier calls for the clear presentation of study findings, to ensure that results that have been carefully gathered are appropriately communicated.[1][1] The Global Alliance for Publication Professionals agrees with these sentiments, and states, “Most of the responsibility

To meet ethical and scientific obligations, authors should submit timely, high-quality manuscripts. Authors, however, can encounter ethical (e.g., authorship designation) and practical (e.g., time and resource limitations) challenges during manuscript preparation. Could professional medical writers-not ghostwriters-help authors address these challenges? This essay summarizes evidence countering three myths that may have hindered authors from considering the use of professional medical writers. Authors with sufficient time, writing expertise, and reporting guideline knowledge may meet their obligations without writing assistance. Unfortunately, not all authors are in this position. Decisions about writing support should be based on evidence, not myths.

International Conference on Harmonisation (ICH) E6 and ICH E3, developed nearly 20 years ago, are the current regulatory guidance documents for developing clinical study protocols (CSPs) and clinical study reports (CSRs). Ambiguity in the guidelines, and recent public disclosure requirements mean that review and revision of these guidelines is warranted. In May 2014, EMWA assembled a group of experts, called the Budapest Working Group (BWG), and initiated a 2-year collaboration with a variety of stakeholders to review the two guidelines. The resulting recommendations should address the needs of the widest possible community; incorporate developments since the guidelines were first issued; and facilitate responsible clinical trial data sharing. In this first of three planned open-access publications, we explain the objectives of this project, present our 2-year project plan, and report on progress to date.

If patients knew that most results from clinical research were not shared as completely or as quickly as they should be, how many patients would volunteer for research studies?If patients knew this...

Objective: Using a Delphi consultation process, a group of medical writers established by the European Medical Writers Association (EMWA) set out to determine the current thinking on the problems of ghostwriting in medical publications and what should be done about them. In this context, ghostwriting is where a professional medical writer prepares a manuscript on behalf of a named author, but the writer is not listed as an author. Methods: A 4-round Delphi consultation process was conducted via email to generate statements about the main issues in ghostwriting. Participants rated their agreement with the statements on a scale of of 0-10. Results and conclusions: Members of the task force strongly believed that professional medical writers can improve the quality of scientific papers, but that this fact is often not recognised outside the medical writing profession. At least in part, this is because of a perception that ghostwritten papers may have been inappropriately influenced by pharmaceutical companies. One theme that emerged strongly from the discussions was transparency. Members thought it very important that the existence of a ghostwriter should always be made clear to the reader. Another strong theme was the importance of defining In detail what practices relating to ghostwriting are ethical, and what practices are not. This definition of ethical ghostwriting should be widely known, and unethical ghostwriting should be strongly condemned. Use of the term 'ghostwriting' itself was questioned. Members of the task force felt that use of a more neutral term should be encouraged. The task force suggested various activities for ensuring that the above objectives could be met, including discussions with other interested parties, such as journal editors and pharmaceutical companies, educating medical writers about ethical practices, further research into ghostwriting, and developing guidelines for ethical medical writing.

The pharmaceutical industry has been a soft target for many years. Attacks by journalists, politicians, and the lay public tend to be triggered by publications with which professional medical writers are associated. Fault is found, either in the content, perceived obfuscation of content, or on perceived deceptive authorship practices. The term ‘ghostwriter’ is used with great frequency and is often misapplied, or ill-defined (if it is defined, at all). For the most part, these criticisms have gone unanswered. We must understand that we represent the potential for the strongest and most influential voice in refuting misinformation and misunderstanding about our role. We must educate our critics about the value that we bring to communications about new therapies. We are our own best advocates in ensuring that critics of our profession are brought out of the wilderness.

Dear Editor, We thank Dr. Schofferman and colleagues for warning readers about the many perils of ghost and guest authorship [1]. The exact prevalence of these unethical practices is difficult to determine partly because of the use of different definitions and lack of well-designed studies. Schofferman et al. are to be commended for selecting standard definitions and for citing serial surveys suggesting that the prevalence has declined over time. Unfortunately, ghosting and other unethical authorship practices have not disappeared. As members of the Global Alliance of Publication Professionals (GAPP; www.gappteam.org), we appreciate their recognition of professional medical writers as “legitimate participants in scientific papers provided their role is transparent.” We wish to expand on their commentary by adding recent references that may provide insight about how to exorcise the ghosts from published medical information. Schofferman et al. referred to authorship guidelines from the International Committee of Medical Journal Editors (ICJME) [2], which are used by more than 500 medical journals, including Pain Medicine . As noted …

In this commentary, we present evidence that unethical authorship (eg, guest and ghost authoring) and other publication practices are not restricted to the pharmaceutical industry; they also occur in academia. Such practices are not an industry problem—they are a research problem. To enhance trust in industry-sponsored research, companies have made rapid and far-reaching changes to their publication guidelines, policies, and procedures. Professional medical writers have adopted, and continue to implement, these changes. Although evidence indicates that industry practices are improving, there is certainly more to do, both in industry and academia. We invite readers to join ongoing efforts to promote ethical publication practices.

The International Society for Medical Publication Professionals (ISMPP) is an independent, nonprofit professional association with members from the pharmaceutical, medical device, and biotechnology industries; publication planning and medical communications companies; academia; and medical journal staffs, including editors and publishers. ISMPP's mission is to support the educational needs of medical publication professionals by providing a forum to facilitate awareness and development of best practices in publication planning and implementation, and fostering consensus policies related to medical publishing. This position statement reflects our concern about the current climate of mistrust regarding the use of professional medical writers in the preparation of manuscripts. We acknowledge the skills and training of medical writing professionals and support their role in working with research teams to develop clear and concise manuscripts in a timely fashion. Further, we support complete and transparent disclosure of the role of the medical writer and the source of funding for the writing initiative in order to build awareness of, and trust in, the appropriate use of medical writing professionals. ISMPP endorses use of the contributorship model, which offers detailed information on the roles of all who participated in planning, conducting, developing, and publishing medical research. Further, we propose that this model be integrated into the standard operating procedures of the diverse organizations that comprise our membership because the responsibility for authorship disclosure is shared by sponsors, authors, study investigators, and medical writers. Finally, we commend the many organizations that have worked to increase recognition and understanding of the legitimate role of the medical writer, and are eager to work in concert with them to ensure the rigorous maintenance of all ethical standards for reporting the results of medical research.

T o the Editors: We read with interest Roper and Korenstein’s article entitled Industry Collaboration and Primary Guest Authorship of High-Impact Randomized Clinical Trials: A Cross-Sectional Study, which appears to show a decrease in the prevalence of guest authorship compared with previous studies. As leaders of the Global Alliance of Publication Professionals – GAPP (www.gappteam.org), we have been, and continue to be, strong and vocal critics of inappropriate authorship. However, we are wary about how comparable this study is with the others cited by the authors. Roper and Korenstein open their article by defining guest authorship as Battribution of research article authorship to investigators not meeting standard authorship criteria,^ yet fail to use standard authorship criteria in their study. They also suggest their guest authorship criteria are conservative and may underestimate the true prevalence of guest authorship. We disagree, as Roper and Korenstein focus only on the first part of the second International Committee of Medical Journal Editors (ICMJE) criterion. By limiting their definition of authorship to Bdrafting the work^ and ignoring Bor revising it critically for important intellectual content^, they lower the bar to guest author status and inflate prevalence estimates over apparently similar studies. We also disagree that the initial writing of the manuscript is Bgenerally^ viewed as the responsibility of the primary author(s). There is no such guidance in the ICMJE criteria, though we acknowledge that there are a few journals that specify this in their individual instructions for authors. The ICMJE authorship criteria are viewed bymany as flawed, but they are widely accepted by journals and publishers. It would be helpful they were applied consistently in studies such as these. In the interests of full disclosure, all members of GAPP have provided or do provide ethical medical writing services to academic, biotechnology, or pharmaceutical clients, and all authors are active in national and international not-for-profit associations that encourage ethical medical writing practices. Jackie Marchington, PhD, CMPP, Director of Operations, Caudex, UK, on behalf of the Global Alliance of Publication Professionals (www.gappteam.org).

Background to the debate: Ghostwriting occurs when someone makes substantial contributions to a manuscript without attribution or disclosure. It is considered bad publication practice in the medical sciences, and some argue it is scientific misconduct. At its extreme, medical ghostwriting involves pharmaceutical companies hiring professional writers to produce papers promoting their products but hiding those contributions and instead naming academic physicians or scientists as the authors. To improve transparency, many editors' associations and journals allow professional medical writers to contribute to the writing of papers without being listed as authors provided their role is acknowledged. This debate examines how best to tackle ghostwriting in the medical literature from the perspectives of a researcher, an editor, and the professional medical writer., In a debate Peter Gøtzsche argues that ghostwriting in medical literature is scientific misconduct, Jerome Kassirer says more evidence is needed, and Karen Woolley and colleagues propose an explicit role for professional medical writers.

Interventional clinical studies conducted in the regulated drug research environment are reported using International Council for Harmonisation (ICH) regulatory guidance documents: ICH E3 on the structure and content of clinical study reports (CSRs) published in 1995 and ICH E3 supplementary Questions & Answers (Q & A) published in 2012. Since the ICH guidance documents were published, there has been heightened awareness of the importance of disclosure of clinical study results. The use of the CSR as a key source document to fulfil emerging obligations has resulted in a re-examination of how ICH guidelines are applied in CSR preparation. The dynamic regulatory and modern drug development environments create emerging reporting challenges. Regulatory medical writing and statistical professionals developed Clarity and Openness in Reporting: E3-based (CORE) Reference over a 2-year period. Stakeholders contributing expertise included a global industry association, regulatory agency, patient advocate, academic and Principal Investigator representatives. CORE Reference should help authors navigate relevant guidelines as they create CSR content relevant for today’s studies. It offers practical suggestions for developing CSRs that will require minimum redaction and modification prior to public disclosure. CORE Reference comprises a Preface, followed by the actual resource. The Preface clarifies intended use and underlying principles that inform resource utility. The Preface lists references contributing to development of the resource, which broadly fall into ‘regulatory’ and ‘public disclosure’ categories. The resource includes ICH E3 guidance text, ICH E3 Q & A 2012-derived guidance text and CORE Reference text, distinguished from one another through the use of shading. Rationale comments are used throughout for clarification purposes. A separate mapping tool comparing ICH E3 sectional structure and CORE Reference sectional structure is also provided. Together, CORE Reference and the mapping tool constitute the user manual. This publication is intended to enhance the use, understanding and dissemination of CORE Reference. The CORE Reference user manual and the associated website ( http://www.core-reference.org ) should improve the reporting of interventional clinical studies. Periodic updates of CORE Reference are planned to maintain its relevance. CORE Reference was registered with http://www.equator-network.org on 23 March 2015.