The 2018 Annual International Publication Planning Meeting (TIPPA) was held in San Diego on 5–6 February. A summary of the first day of the meeting is provided below for those who could not attend, and as a timely reminder of the highlights for those who did. Day one focused on what to look for in 2018, improving the publication lifecycle, how to professionally develop within publication planning, skills for working with non-publication professionals, client–agency partnerships, authorship and transparency guidelines, including real world evidence (RWE) studies in your plan, and writing lay summaries.
Chairperson’s opening remarks
Richard White (Oxford Pharmagenesis) began the meeting by providing an overview of some key trends that are likely to impact on medical publications professionals either now or in the future. He began by highlighting that technology companies are becoming increasingly involved in healthcare (examples were provided from Amazon and Apple amongst others). Any research conducted by these companies would most likely need to be written up in peer reviewed publications – hence providing a potential area of opportunity for our industry.
Other trends highlighted by White included the arrival of cell and gene therapies (which are likely to lead to improved outcomes for many patients, but which are associated with a high cost) and the increasing demand for RWE and healthcare economic information (HCEI).
However, White cautioned that the medical publication’s industry remains under close scrutiny, with greater calls for transparency. In this respect, sharing of individual patient data is becoming a reality. As an example, White mentioned the International Committee of Medical Journal Editors (ICMJE) update on the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, including the requirement for incorporating data sharing statements in clinical trial publications. However, the industry must balance the needs for greater data sharing with ensuring privacy for study participants – particularly with the view that the European General Data Protection Regulation (GDPR) will come into effect in May 2018 – with significant fines for non-compliance
White went onto suggest various solutions to help improve the credibility and transparency of our profession, including Open Pharma (an initiative to identify the changes that are needed in our industry and how they might be achieved), increased open access (citing the recent example of Shire mandating open access for all publications), and the consistent use of digital identifiers to distinguish individual researchers in publications and better acknowledge their contributions (e.g. ORCID and CRedIT).
Issues for 2018. What’s on the horizon for publication planning professionals
Next, Art Gertel (MedSciComm, LLC) and Marion Enie (Envision Pharma Group) provided insights into what is on the horizon for medical publications professionals.
During the talk, Gertel explained the current US FDA guidance relating to expanded access programmes. This FDA guidance enables patients to gain access to a drug prior to approval, providing that important, well-defined considerations are addressed and met. The purpose of the guidance is to ensure patients with a serious or life-threatening condition receive appropriate treatment. However, Gertel cautioned that “Right to try legislation” is being implemented in the USA and will be important for publication planners to be aware of. This legislation was approved in August 2017 by the USA senate and allows extremely sick patients to be given access to unapproved, experimental medication after phase I clinical development. This may mean that patients receive a drug that has been insufficiently tested for efficacy or safety in its target population, which usually only occurs in phase II development. Bioethicists and medical experts have voiced concerns in relation to this legislation.
The next topic in this talk related to clinical trial transparency. In this respect, clinical trial disclosure is continuing to improve within the pharmaceutical industry. In the future, patient-level data from clinical trials will also be increasingly made available to researchers. However, personal data must be protected and commercially confidential information redacted. In this respect, great care will be needed to balance protecting personal data from small trials (which have low numbers of patients) and also from trials of patients with rare diseases. This will be particularly critical given that the European GDPR will be implemented in May 2018. This legislation applies to any organisation in the world that stores or processes European Union consumer data. Finally, Gertel mentioned that the FDA has announced a pilot programme to encourage the sharing of protocols, clinical study reports and statistical analyses, which may bring the FDA in line with the European Medicines Agency (EMA).
Also in the talk, the speakers discussed the increasingly important issue of patient engagement (which was discussed in greater detail later in the day; see below in this report). Finally, the subject of corporate integrity agreements (CIAs) was discussed. It was concluded that CIAs have raised awareness of the need for publications processes and publication-tracking systems within pharmaceutical and biotechnology companies. In doing so, they have helped to raise standards. It was also stated that a typical CIA is closely related with well-established industry guidance, such as ICMJE and Good Publication Practice-3. These are guidelines that medical publication professionals should be following on a day-to-day basis, irrespective of a CIA.
Improving strategic publication planning through the publication lifecycle
Yaming Wang and Peter Agathangelou (both from Prime Medica) emphasised that the goal of a publication plan is to ensure physicians/healthcare providers are informed about medications through publications in a timely way, with the aim of improving the lives of patients. However, when developing a publication plan, critical elements are often inadequately addressed, as summarised in the table below:
|Critical element that is often inadequately addressed||Potential solution|
|Publication planning is often not started until later in a product’s lifecycle||Publication planning should start as early as possible in a product lifecycle. Starting early will help to ensure that data gaps are addressed|
|Measuring the impact of publications||Research should be conducted to measure whether target audiences read and understand what has been published. This can be achieved by analysing independent websites, congress news, field-based team feedback, social media, syndicate research, online discussion forums, and market research insights|
|Enhanced digital content||Journals are actively encouraging complementary digital content (e.g. video abstract, slide deck with voice over, podcasts, etc), which may add value to publications. Early planning is essential to achieve optimal impact of digital content, and perhaps any ideas could be discussed in initial kick-off calls with authors|
|Other parameters aside from impact factor should be considered when selecting a journal||Other factors to consider include readership/relevance, reach, open access, enhanced digital content, rejection rate and speed of publication|
|Early and frequent engagement with trusted external experts||Trusted external experts should be engaged at every stage of the publication planning process, including gap analysis (i.e. identifying unmet needs and evidence gaps), implementation (i.e. development of publications), and pressure testing the plan|
Yaming Wang and Peter Agathangelou also emphasised that a consistent scientific narrative should run through all communications within a publication plan. This narrative should be robust, compelling, and dynamic over time. Ideally, medical publications professionals should be considering the narrative development as early as possible within the product lifecycle and this process should engage key internal and external stakeholders. They mentioned that a lexicon might help to complement the narrative to help ensure all stakeholders are using consistent terminology/language. This can be particularly important for a new drug class with a novel mechanism of action, where it is critical to be clear when describing the molecule or biologic and how it works.
Professional development in publication planning: what it takes to bring you and the industry to the next level
In this talk, Dheepa Chari (Pfizer Oncology) emphasised that there are many different paths open for publication planning professionals, and also many paths for people to get to publication planning.
Chari described several important ways for professionals to achieve their ambitions, emphasising the importance for a job to be inspiring, motivating, challenging and rewarding:
- An effective development plan will help build and identify personal skill sets. Make the time to build and monitor your development plan.
- Always look for opportunities to innovate. To get noticed, set yourself apart by thinking differently. Try and champion new ideas in your workplace.
- Define your personal story and sell yourself.
- Know yourself and adapt your communication style depending who you are communicating with.
- Establish authentic relationships through networking internally and externally. Build your reputation and grow your network. Face-to-face dialogue is important, as is making yourself available and accessible.
- Ultimately position yourself as a leader in your functional line and amongst your peer group.
Skills for working with non-publication professionals in your company
Gordon Muir-Jones (Porterhouse Medical Ltd) and Val Injev (Alcon) provided insights on the skills needed to work with non-publication professionals. They explained that publication planning involves diverse and complex relationships with many internal and external stakeholders. To ensure that these relationships are successful and productive, medical publication professionals need to ensure that the structure of a publication planning group is appropriate, that accountabilities are well-defined, that there is strong buy-in to the plan, and that expectations are suitably managed.
When working with authors, it is important to establish a good rapport from the start. A committee should ideally be formed before results are available to formulate the plan and publication concepts. Authors should be requested to sign an agreement form up front before publication development begins, which summarises roles and responsibilities, and includes information on the Sunshine Act, ICMJE requirements, and potential medical writing support. A kick-off call with authors at the beginning of publication development can help with alignment and ensure that authors are aware of timelines. Throughout publication development, external author should be regularly updated on the status. Finally, it was mentioned that a “defensible selection criteria” should be established to explain author order and selection.
When selecting a medical writer or an agency, it is imperative that they are well trained, appropriately educated and knowledgeable about guidelines and ethics. It was suggested that agencies can be a useful resource for best practice sharing (based on their experiences with other pharma/biotech/device companies), for gaining informed guidance and ongoing counsel, for moral support, and for “pain” control.
To help smooth communication channels with internal colleagues, it is imperative to hold regular status meetings, to encourage open and direct communications, to have regular phone calls / in person meetings with key stakeholders, and to share relevant information through the organisation. It is also critical to educate other members of a cross-functional team on the importance of publications in general – and also on the importance of following guidelines, such as ICMJE and Good Publication Practice-3.
Engaging key customer segments regularly, efficiently, and compliantly via online discussions
In this talk, Michael Kirby and Natalie DiMambro (Within3) provided an overview of their proprietary online discussion platform, which allows organisations to compliantly engage physicians, nurses, payers, and patients in groups large or small. This platform is similar to LinkedIn, but in a private system. It enables companies to engage with healthcare professionals, and for healthcare professionals to engage with each other, in real time. Adaptations to the system have made it increasingly more useful for publication planners, particularly since authors can now collaborate simultaneously on the online review of a publication at the same time. Within3 partners with 18 of the top 20 pharmaceutical companies, as well as leading medical organisations and agencies, in over 140 countries.
Best practices for a successful client–agency partnership
George Samman (Pfizer) and Lisa Shupe (Peloton Advantage, LLC) provided a summary of the key factors that they feel are essential for a successful client–agency relationship. It was stated that collaboration and dialogue are critical, that both parties should have a shared vision and goals, and that there should be clear expectation and accountabilities. It was also emphasised that there should be trust and respect amongst team members, as well as honesty, openness and understanding.
Key performance indicators (KPIs) given by the speakers for a successful client–agency relationship are summarised in the table below:
|KPIs from a client perspective||KPIs from an agency perspective|
|Awareness and commitment of adherences to industry standard publication practices||Insights and intellectual contribution to the project|
|Knowledge of client’s publications policies and practices||Quality of medical writing and getting it right quickly, including accuracy/fact checking|
|Senior management accessibility and professionalism||Demonstrate learning and apply lessons learned across other projects|
|Project management expertise, including adherence to project timelines, and strong financial management||Adherence to timelines and accurate and timely financial management
|Proactive approach in overall team/plan management, including anticipation of team’s needs, surfacing ideas/solutions and identification of issues||Attentive client service, ease of doing business, and professionalism with external experts|
From an agency perspective, to maintain and measure a successful relationship, regular meeting cycles should be established with clients to review progress, address gaps and identify improvement areas. There should be no more than 2 months between substantive touchpoints. Regular surveys (e.g. through surveymonkey) can help to ascertain anonymous feedback (potentially including procurement team members in addition to main client contacts). It was suggested that these surveys an be followed up with phone calls from independent third parties to gain anonymous, more in-depth feedback.
Samman mentioned that Pfizer have their own vendor oversight plan, which was started in 2012. This plan includes a 360-degree vendor management survey (Pfizer rate the agency and the agency rate Pfizer). Following this survey, an annual performance discussion takes place between Pfizer and their vendors, which includes initiation of a remediation process if areas of concern are identified. Samman stated that this process has created a safe environment for all parties to freely discuss concerns.
Issues in authorship and ghostwriting
Despite the availability of the ICMJE and Good Publication Practice-3 guidelines, questions still continuously arise regarding authorship, according to Lisa DeTora (Hofstra University), Lynne Gordon (Theravance Biopharma Inc) and Maura McGrail (Peloton Advantage, LLC). Specifically, there was a considerable discussion about the problems that can be associated with trying to gain substantial contribution / critical revision / intellectual content from authors.
It was stated that authors should be encouraged to ideally provide the same level of contribution as a peer reviewer (i.e. “if you were reviewing this for a major peer reviewed journal, what would you critique?”). To help gain author contributions, it is important to try to choose authors who are responsive and enthusiastic. Kick-off calls at the start of a publication’s development, as well as calls during development, can be helpful for gaining contributions. In a kick-off call, it should be reiterated what is required from the authors – including the need for critical revisions – and what the consequences will be if substantial feedback is not provided. Minutes from calls should be written up to ensure there is an appropriate audit trail. Finally, in drafts of a publication, specific questions should be asked, so that authors are encouraged to give their thoughts and intellectual input. This can be particularly important for the discussion and conclusions sections.
HEOR, RWE and PRO studies: opportunities and challenges for publication planning and development
Richard White (Oxford Pharmagenesis), spoke about the value of publishing RWE, stating that these studies are becoming increasingly important for regulators and payers. He also emphasised that new legislation (21st Century Cures Act; “Section 3037: Health Care Economic Information”) will most likely provide additional flexibility for drug companies to communicate proactively to payers and formulary committees about RWE studies.
White described meta analyses of randomised controlled trials (RCTs) as the “shining light” and that RWE, such as observational studies, are perceived to be less important. However, RWE is a measure of the effectiveness of a drug in clinical practice as opposed to its efficacy in a very well-defined, controlled population (such as that measured in a RCT). In fact, both sets of data complement each other. RWE can give an indication of how healthcare professionals and patients use the drugs day-to-day when not constrained by trial protocols. White acknowledged that a majority of readers consider the quality of RWE as less robust than RCT results, and that further education and communication around RWE is needed.
White went on to describe some key areas that may help in boosting the credibility of RWE studies. Articles must fully explain the methods employed to minimise bias and confounding, as the lack of randomisation and risk of bias can be seen as a problem. The choice of data source, whether it be a claims database, disease registry or electronic health records should be justified. It is essential that the patient population investigated provides a reasonable representation of what is being measured. There is concern that although a large number of RWE studies are undertaken, only positive data is published. The same rigour that has been implemented in the publication of RCTs must be adopted by RWE studies.
In this respect, new guidance from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) task force provides important guidance on the conduct and reporting of RWE studies. According to the new guidance, hypothesis evaluating treatment effectiveness studies (HETE studies), need to commit to:
- Posting the study protocol and analysis plan prior to study.
- Publishing study results noting any deviation from the study protocol and original analysis plan.
- Reporting with sufficient transparency to reproduce findings using the same dataset and analysis.
- Validating the analysis in a different data source / population.
- Publicly addressing methodological criticisms of the study.
- Including stakeholders in designing, conducting and disseminating HETE studies.
The increasing presence of lay summaries and patient voice in publications
Day one of the meeting was rounded off by Jamie Weiss (Novartis) and Lisa DeTora (Hofstra University), who gave their insights into how patients are becoming increasingly involved in research and publications, including via:
- Development of publications and grant proposals
- Review and development of clinical trial lay summaries
- Presentations at congresses
- Authorship / research
- Journal partnerships
- Scientific advice groups / advisory boards for clinical trials.
Several ideas were proposed (based on a publication by Nierse et al.) for how to collect data from patients for inclusion in publications. These included: in-depth interviews, focus groups, participant observation, focus on experiential knowledge, mutual learning, and openness and respect. While any data obtained from this type of research would be qualitative in nature (so less rigorous than quantitative evidence), it can provide different insights, providing a valuable understanding of the patient journey. Indeed, the patient perspective may generate new hypotheses and perspectives.
Weiss provided an overview of lay summaries and stated that different types exist for regulatory purposes, for journals, and for providing a summary of results to clinical trial participants. She continued by giving details of the legislation for clinical trials performed in the European Union, which will include 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.
While the prominence of lay summaries is increasing, there are also challenges and outstanding questions. Lay summaries may be seen as promotional, since they may present material for unapproved uses or make comparative statements about other therapies. They may also be oversimplified to the point of being misleading. Additionally, they may lead to information overload and be unintentionally obfuscating. Finally, the ideal format/structure of a lay summary still needs to be agreed. In relation to this last point, a brief guide to developing lay summaries was presented:
- Users should understand information at first try.
- The most important information should come first.
- Complex information should be presented in understandable chunks.
- Simple language should be used and technical terms defined.
- Active voice should be used.
- Links should be provided to web pages that provide information about current standards of care.
- Disclaimers and limitations should be large, clear and easy to understand (maybe at the top of summary).
As a final point, it was emphasised that patients should be consulted for feedback and review. These “test patients” should ideally be derived from target user groups (i.e. patients with the disease or likely to be impacted by the clinical research).
A summary of the second day of the meeting will follow shortly.