On February 29th 2016, the 15th Annual International Publication Planning Association (TIPPA) meeting convened for two days in San Diego, CA to discuss the evolving challenges impacting on the publications community. A summary of the second day of the meeting is provided below. A summary of the first day of the meeting can be found here.

Day 2: Tuesday 1st March 2016

 Journal editor perspective – trends in publishing for 2016 and beyond

This session was moderated by Lisa DeTora (Assistant Professor of Writing Studies, Hofstra University). Leslie Citrome (Editor-in-Chief, International Journal of Clinical Practice; Clinical Professor of Psychiatry and Behavioral Sciences, New York Medical College) started the discussion by listing top trends in publishing, which included the increasing use of open access, the evolution of metrics, and the disappearance of paper journals. Included in his discussion on metrics, was the increasing popularity of alternative metrics (including the altmetric score), which measure the attention a publication receives in the news, blogs, tweets, and other social media. (Altmetric scores can easily be obtained for any publication with a DOI through a free Altmetric plug-in.) He also suggested the audience view impact factors and other metrics with caution due to gaming techniques that overinflate the score. Rounding out his list were fraud control, experimentation with aspects of peer review and remuneration due to difficulty in finding reviewers, and more guidance for authors to help reduce editorial workload and make sure the “right” articles are published.

Alan Lyles (Henry A. Rosenberg Professor of Government, Business and Nonprofit Partnerships, University of Baltimore; Docent, Faculty of Pharmacy, University of Helsinki) continued the discussion and listed reproducibility, open peer review and patient peer review as top publishing trends. He also mentioned the expanded use of impact metrics, such as the altmetric score and scoring views and downloads.  He noted that the inclusion of pharmacoeconomic information in publications is increasing, which is a challenge due to the dearth of reviewers. Similar to Leslie, he sees author assistance increasing. He also agreed that the flood of publications is a real issue for editors and encourages authors to use guidance for submissions. Within this discussion, he noted that a main reason why journals reject articles is due to a poorly written abstract and emphasized the need to provide context within the abstract.

The benefits and challenges of integrating health economics and outcomes research (HEOR) data into your publications

Susan Ryan (Medical Communications Strategic Director, InScience Communications) started this session by discussing the rise in HEOR publications, which is driven in part by the increasing role of payers in healthcare decision making. Data for HEOR publications is post-launch real-world evidence and can be extracted from a wealth of sources including electronic medical records, PROs, administrative claims, insurance claims data, national surveys, and patient registries. 

She went on to state that adding HEOR modelling to the publication plan is important since it can identify cost drivers associated with a drug/therapy area, allow for comparison with competitors without the need for clinical trials, and offers more opportunities to communicate and publish. However, one current transparency issue with HEOR that she did mention is that companies are not obligated to publish if the findings are not in their favor (i.e.  final data may not be supportive of the desired message).  Additionally, she noted that it is necessary to have at least 12 months of post-launch real-world data in order to have a robust study and emphasized the need to ask the “right questions” to get the “right answer”. She finished her discussion indicating the need to define internal interpretations of publication guidelines, particularly if paying a consultant to perform the data analysis.

Dheepa Chari (Director, US Scientific Communications, Novartis Pharmaceuticals Corporation) continued the conversation by discussing her experience with integrating HEOR into publication plans. She noted that for the past couple years, the HEOR team and publications teams have been closely integrated. She described the importance of understanding what each team does and how this helped them to integrate HEOR publications into the overall plan up front. One question they are currently discussing is the best way to interpret their economic data from a medical perspective and discern whether there are more opportunities to utilize the information.  She mentioned the idea of writing HEOR-based review articles, which may ultimately consolidate the information and present it in a more impactful way.

Case study: Authorship selection issues

Neil Matheson (Global Chief Executive Officer, Huntsworth Health) started off the session by asking the audience a number of questions regarding publication planning. It was discovered that 33% (the majority) felt that a publication steering committee should be formed as early as possible. Interestingly, however, most of the audience reported working with a publication steering committees less than 50% of the time.

He then engaged the audience in discussion by walking through several difficult, real-world cases of involving conflict in steering committees as well as authorship selection. He spoke of a steering committee with conflicting views due to regional differences in medical practice. This committee also had different types of specialists, which added to the complexity of the discussion.  He encouraged the audience to think about these issues during steering committee selection and if/when it is appropriate for the sponsor to step in to resolve these issues.  

He followed this with examples of authors desiring authorship or senior authorship positions without proper contributions and went on to describe a method developed by his team to help determine authorship rank. This method involves the scoring of several parameters including data analysis contribution, patient enrollment. He concluded by suggesting that if there is not clear guidance on a particular authorship situation, company policy and common sense should steer the decision. He also emphasized the importance of establishing clear authorship guidelines up front to help avoid these issues.

Two years of Sunshine – how are we doing?

Carolyn McAuliffe (Director, Medical Communications, Masimo Corporation) opened this session with a discussion surrounding the current requirement for manufacturers of pharmaceutical drugs and devices, as well as group purchasing organizations, to report any payments to US healthcare professionals (HCP) and teaching institutions. She went on to  acknowledge that there are many different interpretations of HCP payments and transfer of value (TOV). Currently, there are several published guidelines to assist in interpretation of the Sunshine Act, such as those published by the International Society for Medical Publishing Professionals (ISMPP), Centers for Medicare and Medicaid Services (CMS), and the American Medical Association (AMA). However, Carolyn also suggested having discussions with company legal and compliance teams. She noted that it behooves the pharmaceutical industry to participate not only as an ethical commitment to the community but to ensure that clinical decision making is based on the patient’s best interest.

Dikran Toroser (Medical Writing Senior Manager, Amgen) followed this up with a discussion on the Sunshine Act from a medical writer’s perspective. He reported that relationships with US authors have not changed drastically, but emphasized the importance of informing authors upfront that there may be a TOV reported. He also said that it hasn’t drastically changed the way they operate, but the extra processes involved can be time consuming to follow. Between 2015 and 2016 he has seen an improvement in processes, and noted that they no longer perform TOV calculations at the time of submission, but at the time of acceptance, which streamlines the process. He has also noticed that stakeholders and colleagues are increasingly knowledgeable about the Sunshine Act.

Marion Enie (Operational Excellence Lead, Envision Pharma) closed the session by reviewing a survey on reporting TOV trends that was performed by Envision. Through the survey, which included 28 companies of varying size, they determined that larger companies are more likely to report than smaller companies, though she acknowledged that reporting was still quite low, even for this group (~50%). They also found that the method of calculation and frequency of reporting varied greatly by company and were surprised to find that the presence of a corporate integrity agreement doesn’t seem to affect the decision to report. When surveying the meeting audience, ~50% of the attendees indicated that their companies were reporting and discussions followed surrounding the risk/benefit of not reporting.

Publication contracting made simple

This session was chaired by Welyn Bui (Executive Vice President, Scientific Communications, Meridius Health Communications). George Samman (Director of Operations/Team Leader, Pfizer, Inc.) gave an account of his experience at Pfizer, where it took an average of 45 business days to fully execute a contract for medical writing services. This protracted system led him to look at alternative approaches, and he assessed systems already in place in their procurement department. He noted the financial benefit of building a system from software already owned by the company and led the audience through the development and implementation of their new contracting system on Decideware, which has reduced the time spent on contracts by 60%. Additionally, it allows users to easily track the contract and offers a formal repository for easy access. He ended the session by stressing the importance of surveying other departments within your company when trying to solve system issues.

Extending the reach of your publication through advanced technology

Next, Tim Collinson (Business Unit Head, West Coast, Fishawack Communications) spoke about alternative methods to extend the reach of publications. Within this topic he discussed the potential for interactive ebooks, supplemental video data, and extending the use of Quick Response (QR) codes to link to interactive material, such as videos of poster presentations.

He also discussed the value of engaging in social media, where the primary objectives should be to monitor activity, redirect to other relevant information, and converse with the audience. He also highlighted the additional benefit of being able to extract metrics from social media activities.

He named several issues holding the field back from embracing new technology, such as lack of support from legal/compliance, difficulty in measuring return on investment and a generational gap. However, he encouraged the audience to work through these issues.

Transparency in the clinical trial design – spotlight on the protocol

In the final session of the meeting, Lisa DeTora (Assistant Professor of Writing Studies, Hofstra University) spoke about transparency in clinical trial design and first described how clinical trial transparency emerged.  She stated that in addition to high profile legal cases of “data hiding”, the importance of transparency gained traction from several other factors, including the need for patients to find clinical trials, the call for greater access to data in order to generate more robust, systematic results from meta analyses, and from published guidelines calling for trial registration before publication (such as ICMJE).

She then discussed the difference between publication transparency and trial transparency. Publication transparency involves full disclosure of information such as the origin of the data, who conducted the trial and disclosures of monetary payment or intellectual ties.  Trial transparency centers on what trials are being run, as well as their location, status, results, design, sponsor and payments. She noted the importance of transparency in clinical trials and advised the audience to be honest, offer information, and “not to wait to be asked”.

Finally, she discussed the importance of protocols in transparency.  She reminded the audience that there is a large list of directives on the topic, including ICHE6, the European Directive,  and institutional guidelines. She also emphasized that the audience should remember that the primary goals are to build on known and established knowledge and to maintain ethical standards. She cautioned that innovation is not always desirable and that protocols should be standardized in order to offer valid comparisons between the studies and contribute to metadata. She also noted the importance of writing quality and suggested a free online training resource by Trish Groves at BMJ.

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By Brea Midthune, PhD

Supported by Aspire Scientific. Aspire Scientific is a boutique medical writing and publication planning agency led by professionals with at least a decade of medical writing experience and supported by PhD-educated writers and academics at the forefront of their specialist fields.