Over two days last month (21–22 February 2017), around 100 delegates and exhibitors attended The 16th Annual International Publication Planning (TIPPA) meeting in San Diego. The agenda was centred around collaborative approaches to increasing the reach and readership of global scientific communications, and included topics such as publication planning ethics and guidelines, authorship challenges and ‘ghostwriting’, lay summaries, and maximising the use of social media and enhanced journal content. A summary of the first day of the meeting is provided below for those of you who could not attend, and as a timely reminder of the highlights for those who did. A summary of the second day of the meeting can be found here.
Chairperson’s opening remarks
Richard White (Oxford PharmaGenesis) opened the meeting by considering some of the current challenges facing the pharmaceutical industry, such as pricing pressures and the repeal of the Affordable Care Act, as well as future developments for 2018, like the General Data Protection Regulation in Europe and the start of the US FDA consultation on the use of real-world evidence.
The importance of further building the reputation of the pharmaceutical industry in the publications field, and of medical publication professionals who support the development of publications, was discussed. In Richard’s opinion, publication professionals can achieve this by: demonstrating commitment to responsible data sharing; committing to the transparent and timely publication of results; building evidence that publication professionals improve scientific reporting; using innovative approaches to enhance disclosure of evidence; and engaging with wider initiatives to advance scientific publishing.
Update and guidance on ethical standards and regulations affecting publication planning for 2017
In this first presentation of the day, Marion Enie and Elizabeth Crane (both from Envision Pharma Group) focused on the evolution of regulations and guidelines associated with publication planning and delivery, from 2001 to present day. A full list of all guidelines related to the ethical and compliant reporting and publishing of biomedical research data can be found on the EQUATOR Network’s website. Focusing on the December 2016 update of the ICMJE guidelines, key updates related to predatory journals, retractions/republications, description of participants in trials, discussing the limitations of data, and photographic images used in publications. Other recent initiatives such as recommendations to improve the reporting of adverse events by MPIP, the AMWA‒EMWA‒ISMPP Joint Position Statement on the Role of Professional Medical Writers, and the 10 principles of the GPP3 guidelines were also covered. The presenters noted that Envision have created a bank of case studies that highlight common issues in medical publishing; using explanations from existing guidelines, the case studies serve to support and provide guidance to publication professionals.
With respect to Sunshine Act reporting, the results of a survey of 26 pharmaceutical companies, conducted by Envision, were presented and showed that small companies reported less often than medium or large companies. The level of reporting was not correlated to whether the company was under a Corporate Integrity Agreement. The survey also showed that companies used a variety of reporting methods, e.g. in calculating writing fees and apportioning these to authors. When polled, none of the delegates were aware of any instances of the Centers for Medicare and Medicaid Services having to enforce Sunshine Act reporting procedures. The presentation concluded with a discussion of some potential future issues for publication planners, including the increasing importance of patient engagement, and emerging trends that may impact how patient data are collected and stored (e.g. remote monitoring and ‘cloud’-based systems).
Two-part authorship spotlight
Part one: practical strategies for tackling authorship challenges (Lisa DeTora, Hofstra University; Lynne Gordon, Theravance)
Lisa began by providing a summary of the evolution of the ICMJE authorship criteria and the current guidance, followed by a timely reminder that authorship guidelines other than ICMJE exist, e.g. WAME and those developed by individual journals, associations, medical schools and corporations; all applicable guidelines should be considered when deciding on authorship. Turning her attention to the topic of equitable authorship practices, Lisa presented several considerations and the potentially differing perspectives of the pharmaceutical industry and academia. Such considerations included deciding who qualifies as an author, author order, the balance of internal (i.e. within a pharmaceutical company) versus external authors, and working with global partners.
To underscore the tightly monitored and often scrutinised processes of authorship selection and justification in the pharmaceutical industry, a Theravance Authorship Criteria and Publication Approval Form was presented. The tick-box form was described as a useful method to document how a person qualified for authorship and to track adherence to the authorship criteria throughout the development of the publication.
The first part of this spotlight on authorship finished with tips to encourage author engagement, both from a pharmaceutical industry perspective and academic perspective:
- Industry perspective: communicate timelines, ask specific questions within document to encourage author input, turn to lead author to resolve disputes, phone non-responsive authors
- Academic perspective: ask key questions, set up call for author discussions, encourage intellectual engagement.
Part two: defining ghostwriting – a case‐based discussion (Debra Mayo, Teva)
In the second part of this authorship session, Debra outlined the definition of a ‘ghostwriter’, the widely-defined criteria for scientific authorship, and why professional medical writers in most cases cannot not qualify for authorship. The challenges that exist in the continued debate around ghostwriters, ghost authors and genuine authors were highlighted using some real situations. For example, it is common within Teva for publications to be developed with support from in-house medical writers and this raised questions from legal/compliance departments as to (1) whether this practice constitutes ‘ghostwriting’ and (2) the implications for transfer of value. Another example concerned a paper that had 127 authors (reflecting the study steering committee) and scepticism as to whether everyone genuinely qualified for authorship; this situation highlights the importance of defining authorship in the original study contract with investigators.
Debra proposed that the perception of commercial bias is still prominent. One way to help overcome this challenge is for pharmaceutical companies to publicly post their compliance and publication policies and standard operating procedures. Discussing the contents of a BMJ article published in 2016, Debra pointed out that part of this perceived commercial bias relates to the industry’s interpretation of ‘ghostwriting’ (e.g. it relates to secrecy and non-disclosure) and what it had done to overcome this perception (e.g. disclosure of medical writer’s name and funding in the ‘small print’). The article argues that much more can and should be done to improve the disclosure of professional medical writers, which will help to obviate the perception that ‘ghostwriting’ remains rife in scientific publishing.
Maximize reach through integrated structured publication processes
In this provocative presentation, Jack Yeager (Sylogent) challenged what he perceived as the inefficient processes often currently associated with the development of scientific publications and suggested that improvements were possible. Using examples from other sectors, such as car manufacturing and digital technology, he proposed that there is strong evidence that centralising and standardising processes can lead to automation and increased efficiency. Jack questioned whether these principles can also be applied to publications and data dissemination; in his opinion, many aspects of the publication process can be automated.
The presentation continued by outlining some of the current challenges and barriers to automation of the publication process. For example, there is a need to better define the ‘outcome measure’ of a study (e.g. is it an endpoint or something else?) and to standardise the definition of ‘product’, which often differs from one division to another within a pharmaceutical company. Another challenge is being able to quantify in a predictable manner the level of output of individuals such as medical writers. Jack concluded by challenging the delegates to “think differently” and to consider how automation can play a role in improving the efficiency of publication planning and execution.
ISMPP CMPP™ programme update
Tim Collinson (Fishawack) provided an overview of the recently implemented update to the CMPP™ exam blueprint, which is the framework against which the CMPP™ qualification is built and continuing education (CE) credits are assigned. The update was undertaken as a matter of best practice (such programme reviews should be done every 5 years) and in light of member feedback that the recertification process should be simpler and more accessible. The updated framework includes a new domain called “Monitoring Evolving Trends Related to the Medical Publication Profession” that encompasses items such as non-traditional publication platforms, use of social media to extend the reach of publications, use of publication metrics to inform publication planning, and new data disclosure practices.
The new framework will come into use with the March 2017 exam, and CE credits will be assigned to the new blueprint domains starting this year. The credit structure has also changed, with the certification cycle now running for 3 years (previously 5 years), requiring 30 credits (previously 75), and an annual credit requirement of ≥8, and ≤12 in the final year (previously ≥10 and ≤25 in the final year). Full details of the changes, including the new cost structure and required credits by domain, can be found on the ISMPP website.
Guidelines for writing transparent and timely patient communications and lay summaries
Joanne Wilkinson (Fishawack) began by providing an overview of lay summaries, their definition and the different types that exist (i.e. whether for regulatory purposes, clinical trial participants or journals). She highlighted research showing that 68% of study volunteers would not participate in another trial if they were not given a summary of the results, underscoring the importance of lay summaries. Joanne continued by giving details of new legislation for trials performed in the European Union that includes the obligation of trial sponsors to submit a lay person summary with the study results (expected effective date: October 2018). The FDA may also introduce a similar requirement in the future. The prominence of lay summaries is increasing but there are challenges and outstanding questions, such as perceived data inconsistencies, agreeing which studies should be reported, whether lay summaries can be seen as promotional, and their ideal format/structure.
Continuing the session, Jamie Weiss (Novartis) presented a brief guide to developing lay summaries. Best practice recommendations included: focus on the significance of the research rather than on how it was done; use online tools to simplify writing style (e.g. Atlas of Science), consult lay people and peers in other disciplines for feedback; do not consider the lay summary as a “dumbed-down” version of a typical abstract. Writing a lay summary should be person-centric, present a logical flow of information, utilise short, clear sentences, use an active writing voice, avoid jargon or technical terms, and include simple visuals (with clear labels and simplified keys). In terms of the target audience, it is important to consider experience level.
In the final part of this session, John Czekanski (Fishawack) highlighted the importance of collaboration among pharmaceutical companies, medical writing agencies and patients, all of whom should play a role in guiding best practice for the development of lay summaries. The effectiveness of lay summaries can be measured and improved using metrics to check, for example, if summaries are having an impact, being read, being understood, and are influencing medical decision-making. It was concluded that patients are becoming more involved in all aspects of clinical research, there are benefits to making research findings understandable to the public (e.g. raising awareness and possible improving public health), and that lay summaries are becoming a commonplace approach to facilitate this understanding.
HEOR, RWE and PRO studies: opportunities and challenges for publication planning and development
The demand for health economics and outcomes research (HEOR), real-world evidence (RWE) and patient-reported outcome (PRO) studies is increasing and such studies play an important part in publication plans, explained Richard White (Oxford PharmaGenesis). Despite the interest in, and clinical utility of, such research approaches there are a number of perceived external barriers to their robustness, many of which can be minimised. For example, lack of randomisation and risk of bias can be overcome by using matched controls; questions over the representativeness of results can be answered by being transparent about data sources used; and concerns over publication bias and transparency can be minimised by adopting the same rigour as for randomised control trials (RCTs), e.g. following ISPOR guidelines, and best-practice guidelines for developing publications (as summarised on the EQUATOR network website).
In addition to external barriers, Richard defined some of the internal (operational) challenges that often exist within pharmaceutical companies with regards to HEOR, RWE and PRO research. These challenges include raising awareness of the potential publication opportunities; dealing with the uncertainty of final patient numbers (versus predictable numbers in RCTs); resisting the temptation to continually re-analyse data as the database expands; the need for validation of the methodology used by clinical experts; and appropriate target journal selection (speciality journals are often a better choice over general medical journals). Richard concluded his presentation by giving some best practice tips that included establishing channels for internal communication with HEOR groups and encouraging HEOR vendors to work with medical publications professionals.
The evolution of publication strategies and tactics across the product lifecycle
In this session Dheepa Chari (Pfizer Oncology) and Thomas Gegeny (Scientific Solutions) provided an introduction to publication strategies, how they are developed, how they change over the product lifecycle, and how effective internal communications and partnering with cross-functional groups within a pharmaceutical company underpins success. Dheepa began by explaining that a publication strategy begins with the development of a scientific platform, which considers medical, commercial and health economics perspectives, along with the key communication points for a potential product. A publication strategy often then has three stages, which differ in terms of their priority and focus. The first stage relates to phase 1/2 studies and publications in this stage focus on unmet medical needs and drug mode of action, pharmacokinetics and safety. In the next stage (phase 3 studies), the priority is data dissemination via high-impact publications in top-tier journals. The final stage (post-launch) consists of publications that reinforce information about the safety and efficacy of the product, and its use in clinical practice; for example by publishing data from pooled analyses, meta-analyses, and registry and database studies. It was noted that publication needs can vary across regions and that is it common for a publication strategy to evolve over time, underscoring the need for the publication planning and management process to be flexible and adaptive.
Thomas continued the session by discussing how effective communication and alignment with other internal groups is critical to delivering an effective publication strategy. As information about a product grows so does the internal team, and with this growth comes the need to refine processes to maximise engagement with all key stakeholders. The three pillars of this process are: (1) communication: who receives publication updates and how often?; (2) alignment: partner with cross-functional groups and integration of regional publications into the global plan; (3) engage: encourage medical experts to publish independently and gather clinically relevant insights whenever possible. Thomas rounded off his presentation by providing some examples of tactics that can be used to maximise the impact of publications for broader audiences (e.g. key paper summaries, enhanced journal articles, interactive case learning, lay summaries, online expert commentaries, and congress news coverage) and the importance of metrics to define benchmarks and measure the success of the publication strategy.
Interactive case study forum
In the last session of the day, Sue Sutch (Envision Pharma Group) facilitated an interactive case study forum in which delegates were split into smaller groups to discuss two topical scenarios: (1) publishing case studies and (2) the composition of a publications team. There was good agreement across the groups that major challenges and limitations exist with respect to publishing case studies and most people reported that they do not include case studies in their publication plans. Situations in which a case study may be warranted include to highlight a potential treatment option for a rare condition or in the reporting of very infrequent adverse events (and/or their management).
When discussing who should be on a publications team, the delegates suggested a range of stakeholder groups (as well as the publication manager) including medical, scientific communications, statisticians, payors, health economics and outcomes research, and regional affiliates. Whether there should be interaction between commercial functions and the publications team generated much debate among attendees and, when polled, 8 out of the 10 groups considered this to be acceptable. However, delegates unanimously believed that this involvement should not include the development or review of publications, which aligns with the GPP3 guidelines.
A summary of the second day of the meeting can be found here.