Proceedings from the 9th Annual Meeting of International Society for Medical Publication Professionals Roundtable Session: key insights

Abstract

Introduction

During the 9th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP, April 29–May 1, 2013 in Baltimore, MD), ∼650 participants attended two of 13 available roundtable sessions. Participants included medical publication professionals from industry, communication agencies, and journals.

Discussion topics

Roundtable participants discussed how to best interpret and implement various guidances, such as Good Publication Practices 2 (GPP2), the International Committee of Medical Journal Editors (ICMJE) guidelines, and the Physician Payment Sunshine Act. The impact of and compliance with Corporate Integrity agreements (CIAs) on medical publication planning practices was debated. Roundtable participants also discussed ways of advancing both advocacy for the medical publication professional field and internal and external collaborations. The development of review manuscripts, publications from regions newly emerging in publication planning, medical devices publications, and real-world experience publications were discussed. Participants also considered the benefits and uncertainties of new technologies in medical publications such as multimedia and social media.

Summary

This is the first ever article to be published following the well-attended ISMPP roundtable sessions. The objective of this manuscript is to summarize key learnings that will aid continued discussions about challenges and opportunities facing medical publication professionals.

Keywords::

• Publication management
• Publication planning
• Medical publication professional

Introduction

During the 9th Annual Meeting of the International Society for Medical Publication Professionals (ISMPP)1, ‘Empowering the Medical Publication Community to Advance the Profession’ (April 29–May 1, 2013 in Baltimore, MD), ∼650 participants attended afternoon roundtable sessions. Participants selected two of 13 topics relevant to medical publication professionals for separate discussion in small groups. Each roundtable discussion was moderated by an ISMPP member who had expertise in the given topic area. Roundtable moderators were identified in advance of the roundtable session and provided with written guidance on how best to facilitate a balanced group discussion that encouraged full participation along with varying philosophies and viewpoints.

Participants were stakeholders involved in the publication of medical research, including representatives from pharmaceutical, biotechnology and device companies, medical publications and communications agencies, professional medical writers, as well as publishers and editors of medical journals. Discussion outputs were formally documented by the topic moderators and the key learnings summarized by the ISMPP 2013 Roundtable Committee.

This summary represents the first article ever published based on the roundtable sessions occurring at ISMPP. For the purposes of this paper, the 13 topics were categorized broadly under five themes: ‘Guidances’, ‘CIAs and Impact on Publications’, ‘Advocacy’, ‘Publication Types’, and ‘Other Challenges and New Opportunities for Medical Publication Professionals’. The hopes are that medical publication professionals will be inspired by the key learnings provided here and that this information will promote continued discussion about issues affecting the medical publication professional community.

Topic 1: Guidances

The International Committee of Medical Journal Editors (ICMJE)2 and Good Publication Practices 2 (GPP2)3 guidelines provide guidance/direction for ethical publication practices. ICMJE guidelines, developed by editors for use by authors and editors, define authorship, contributor acknowledgment, and conflict of interest disclosure. GPP2 includes the previous ICMJE author definition, but goes beyond ICMJE by providing policy and procedure recommendations for pharmaceutical and medical device companies. Despite the availability of these guidelines, understanding of ethical practices in publications is a challenge for some authors and industry personnel. Issues that may arise include author-selection criteria, disputes over author sequence, debate over what constitutes guest authorship, failure to understand the ethical role and value of professional medical writers in medical publications, the temptation to use undisclosed writers (ghostwriters), expectation of monetary compensation, and sparse author comments (e.g., ‘looks good’). Additionally, marketing departments may attempt to have input into publication content in some companies.

The cornerstone of adherence to ICMJE and GPP2 guidelines is education at all levels of interest in medical publications. Despite much progress, changing the perception that authorship represents a source of income, is an honor bestowed on a non-author mentor, or involves the use of an unacknowledged writer, will require education of academics, investigators, internal marketing and medical departments, and other stakeholders involved in medical publications. Roundtable discussants noted that publication professionals should be involved early in the study development process to assist in addressing authorship criteria defined in investigator agreements. Company publication policies, which should address transparency and full disclosure, should be presented at investigator meetings. Publication policies should be specified in the author agreement letter at the kick-off of a publication, and authors should be encouraged to respond with detailed comments. Saved email exchanges with authors, conference call notes, and/or author automated system input should be used to document author participation.

Greater specificity in authorship criteria, author sequence and intellectual input, and provision of help in documenting and defining potential concrete steps to improve adherence to authorship criteria are anticipated with GPP3, currently in development. Because some authors still expect honoraria for authorship, and because guest authorship may be considered acceptable in some academic settings, wider and deeper educational efforts—beyond GPP guidelines—are essential.

Education of authors can be provided on an individual basis at project initiation through author agreements, delineation of authorship criteria at kickoff calls, and training through publication steering committees. Other mechanisms include short presentations of authorship guidelines at advisory boards and investigator meetings, and one-on-one education by appropriately trained medical science liaisons. Empowering the lead author to enforce authorship guidelines with peer-to-peer guidance may facilitate adherence.

Educational programs on authorship and the use of publication management systems, beyond the offerings presented at ISMPP meetings, could be developed to promote author understanding of authorship guidelines and good publication practices. The presence of ISMPP at therapeutic area congresses could be another opportunity for author education. Such efforts should extend internationally with cognizance of cultural diversity. Improvement in user-friendliness of publication management systems (e.g., mobile applications and in languages other than English) may encourage use by authors.

A 2010 US law with potential effect on medical publications is the Physician Payment Sunshine Act, more commonly referred to as the ‘Sunshine Act’4. The Centers for Medicare and Medicaid Services (CMS) released the final rules for implementation of the Sunshine Act in early 2013, requiring disclosure of payment or transfer of value from the pharmaceutical/device industry to certain healthcare professionals. The legislation, which is both complex and ambiguous, has raised questions as to whether any assistance provided by a pharmaceutical or medical device company in the development of a publication or presentation is considered a ‘transfer of value’.

Representatives of the ISMPP Sunshine Act Task Force have met with CMS to seek clarification. The CMS gave no definitive answers to the questions posed by ISMPP representatives, but suggested that assistance relating to publications (including abstracts, slides, posters, and manuscripts) probably would be reportable. The tasks associated with publication support include writing, editing, formatting, submitting, and data analysis performed specifically for publications. At the meeting, CMS suggested that a standardized reporting approach supported by solid rationale would be welcome.

As of the writing of this report, the industry has not reached agreement on how to interpret the Sunshine Act regarding publication assistance. Some manufacturers believe that publication assistance is reportable, whereas others do not, and still others are undecided. The most pressing question is how fair market value should be determined if publication assistance is reportable. Should fair market value be based on an estimated level of individual author support, a set amount per publication type, or valued by other means? How will use of internal company authors or medical writers or statisticians affect valuation?

Roundtable discussants noted other questions relating to the Sunshine Act that remain to be answered:

1. How should the value of publication support to authors be determined?

2. How should value assigned to a publication be equitably apportioned to authors and other contributors?

3. How should value be differentiated from cost?

4. How does publication agency pricing impact value?

5. What is the total time and cost for reporting publication support?

6. What constitutes the end-point of publication support, e.g., journal submission or publication?

7. How will public reporting of publication support impact authors’ willingness to continue to receive writing/editorial support?

In light of the lack of direct guidance from CMS, ISMPP has released a suggestions document on the interpretation and implementation of the Sunshine Act with respect to medical publications. The goal of the document is to provide colleagues with suggestions for determination of the value of the support provided by industry to authors of peer-reviewed publications. The suggestions document is based on the research of ISMPP’s Sunshine Act Task Force only and is not intended to represent legal advice.

Topic 2: CIAs and impact on publications

The Corporate Integrity agreement (CIA)5 is a US compliance contractual obligation between the Office of the Inspector General–Human Health Services (OIG-HHS) and a pharmaceutical company, institution, or a healthcare professional. Such an agreement arises from settlements related to alleged healthcare fraud and abuse laws (e.g., off-label promotion, illegal inducement to prescribe). Recent CIAs have included comprehensive requirements for publications that are largely similar to GPP2 and the ICMJE guidelines, but the requirements for needs assessment and a monitoring plan are unique to CIAs.

Roundtable discussants noted that CIAs have raised awareness of the need for publication policies, standard operating procedures (SOPs), and publication-tracking systems to maintain the accurate and robust documentation of required publication processes, and to prepare the organization for internal or external audits. Documentation of needs assessment for the overall publication plan as well as for individual manuscripts can provide the transparency required of the CIA-compliant publication process. Internal monitoring programs check adherence to CIA requirements, which can help prepare a company if audited by an independent review organization.

Development and implementation of publication processes that comply with the CIA warrant close collaboration among various stakeholders. CIAs can be interpreted differently by individual lawyers, leading to varying levels of complexity and publication processes that differ substantially among companies. The imposition of CIAs has added extra steps to the publication process (e.g., internal legal checks, debarment checks, extensive documentation), and has clarified and reinforced publication processes and policies for some companies.

Companies operating under a CIA must train all internal and external stakeholders on the GPP2, ICMJE guidelines, and company-specific publication policies and SOPs. Companies may require agency partners to undergo company-specific training to fulfill the conditions of a CIA, which may be burdensome as it necessitates an extensive time commitment to understand company-specific processes and publication management systems. Publication departments in companies that do not currently operate under a CIA should consider incorporating typical publication-related requirements for a CIA and procedures into their policies, as doing so can insure compliance with non-governmental guidelines and general publication policies.

Topic 3: Advocacy

Advocating for their profession is one of the most important functions of any non-profit group. Once an organization has successfully recruited a sufficient number of members and obtained support from the constituency it serves, such support must be leveraged as the foundation of an effective externally focused advocacy program, not solely concentrated on existing members. Activities that define successful advocacy include building synergistic relationships with mutually agreed objectives with individuals and organizations who have common interests, staying abreast of current developments that impact membership, collaborating with stakeholders, and conveying the society’s message through outreach and education. The collective expertise of ISMPP’s members, as well as its well-earned reputation in the medical publication profession, can make ISMPP a key player in shaping and disseminating awareness of medical publication best practices around the globe. Although ISMPP is making progress toward this goal, roundtable participants felt that more can be done in advocating for ISMPP’s place at the table when pertinent issues related to peer-reviewed medical publications are considered.

Establishing an advocacy program can be fraught with significant challenges. For medical publication professionals, such challenges include convincing various sources, such as academicians and editors, that publication managers are allies in addressing unethical practices such as ghostwriting, ghost authorship, and guest authorship. Furthermore, we need to educate skeptics that professional medical writers are not equivalent to ghostwriters. Professional medical writers declare their involvement and follow ethical publication practices; they provide legitimate support, as requested by international medical journal editors. Perceptions persist that medical publication professionals are not transparent enough in their processes and that the pharmaceutical industry is inappropriately complicit in clinical research and subsequent publication. A strong advocacy plan may help dispel these perceptions, thereby improving the credibility of the profession and of ISMPP. Another challenge is variability in the understanding and implementation of authorship and publication standards and policies, particularly in geographic areas and disciplines that have had limited experience with compliant-driven publication planning and development processes.

Roundtable discussants suggested consideration of the following key questions in planning the ISMPP’s advocacy initiative:

1. Although GPP2 and the Medical Publishing Insights and Practices (MPIP)6 Initiative are good initial efforts, how do we gain access to all individuals and organizations involved in the reporting of medical research?

2. How can ISMPP rebut inaccurate and outdated information related to medical publication?

3. How can ISMPP best support publication professionals who work at mid- to small-sized companies, and those whose companies market non-prescription drugs or devices?

4. How can ISMPP better collaborate with medical research groups, such as those at academic institutions, and how does ISMPP optimize those relationships that are already in place?

5. What professional medical congresses should ISMPP target to raise its profile and build awareness of good publication practice, both via pre-conference seminars and information booths? Where, when, and with whom can ISMPP hold compliance meetings/panels?

Some of these questions are currently being addressed by ISMPP and other organizations, but additional work is needed to broaden advocacy efforts and encourage collaboration, both within ISMPP and with external stakeholders. Roundtable discussants’ suggestions for establishing a well-rounded advocacy effort included: (1) leveraging relationships among members who work in the pharmaceutical industry and their colleagues in other disciplines, especially public affairs and regulatory; (2) developing a speakers’ bureau assembled from high-level ISMPP contributors to provide presentations to industry publication groups, medical congress planners, and professional medical communications organizations such as the American Medical Writers Association (AMWA); (3) recruiting members from other organizations that have a voice in the arena (Association of Clinical Researchers and Educators [ACRE], MPIP, etc.); and (4) establishing a presence at large therapy-area congresses through pre-conference publication workshops. Other activities similar to those performed by other advocacy groups include visits to policy-makers (e.g., United States Congress), developing a members’ ‘tool kit’ and ‘elevator speech’ for disseminating awareness of ISMPP, and presenting current medical publication practices and policies to non-member colleagues and other external stakeholders.

Moreover, ISMPP should consider strengthening its relationship with the Global Alliance of Publication Professionals (GAPP)7. GAPP, which is led by five volunteers who hold leadership positions throughout the world in the medical publication field, was established in 2012 to respond rapidly to publicity that affects medical publication professionals and to publish articles and disseminate information that reinforce the value and ethics of the profession. ISMPP also needs to advocate for the Certified Medical Publication Professional (CMPP™)8 credential as the standard for employment in the field of medical publications and bolster it with an enforceable code of conduct.

In conclusion, ISMPP must take the lead in addressing instructional needs involving global standards and practices, and in making external stakeholders aware of the integrity and value of publications that report medical discovery and clinical research. ISMPP’s advocacy program should originate with the basic idea that all those involved in the publication of information relating to healthcare, whether medical publication professionals, academic or clinical researchers, journal editors and publishers, as well as all of those involved in the reporting of medical research, will benefit by the establishment of a strong coalition and educational partnership. With an effective advocacy program in place, ISMPP can solidify its role as a respected authority on medical publication standards and best practices.

Topic 4: Publication types

Roundtable discussions reflected significant interest in compliance-associated challenges inherent in the development of review manuscripts, publications from regions newly emerging in publication planning, publications related to medical devices, and publications developed from real-world experience.

Whereas review articles provide the reader with a perspective of collective evidence from previous research findings, industry-funded reviews are presumed to be biased by many journal editors, and rejection rates are high compared with unsponsored solicited reviews. In the current environment, systematic reviews are regarded as being of comparatively higher value and are more likely to be accepted than narrative reviews. Many authors are reticent to work on an industry-supported review, unless those articles fill a significant unmet need or offer a novel focus (e.g., mechanism of action of a new molecule). Completing a needs assessment to identify a review manuscript topic is important from both a compliance and practical standpoint. Selection of a target journal based on identified knowledge gaps and determination of journal interest with a pre-submission inquiry may increase the chances of acceptance by appropriate journals.

Developing (lower-income) countries have become increasingly more common sites for global clinical trials, and data arising from these regions will soon take center stage. Global publication plans must take affiliate needs into account (e.g., the use of encore abstracts) and recognize that substantial educational efforts may be needed in these regions to ensure a compliance-driven publication process. Cultural and language barriers as well as limited awareness of appropriate guidelines may contribute to non-compliant publication practices in these regions. In many cases, authors and even affiliate staff (including procurement staff) and agency partners in these regions may view the ‘ICMJE requirements’ or ‘GPP2 guidelines’ as a ‘Western/US need’ rather than a ‘best practice’. Thus, education programs must extend to internal and external stakeholders and address the issues of high-risk, e.g., earning authorship, ensuring data integrity, making complete disclosures, avoiding plagiarism, appropriately acknowledging contributions of professional medical writers, excluding ghostwriters, and rejecting guest authorship. Given the academic pressure to continuously publish research, authors also need education on appropriate selection of journals and the consequences (time and cost) of inappropriate choices.

Beyond education, other strategies can be used to enhance compliant publication practices such as auditing publication processes and outputs, encouraging the use of CMPP™-qualified professionals to act as ‘guarantors’ that ethical publication practices have been followed, and using anti-plagiarism software.

The medical device industry varies considerably from the pharmaceutical industry in its approach to development of new products and to the regulatory approval process. Regulatory authorities use a rigorous approach for devices that support or sustain life, and/or involve significant risk, and grant an expedited pre-market approval status based primarily on results of well-controlled clinical trials demonstrating safety and efficacy. Therefore, data availability and device approval are almost simultaneous, whereas publication of the trial results often follows months later. To ensure timely publication, careful strategic publication planning and tactical implementation, including author engagement, should begin earlier in the development process.

Until recently, US payors have primarily based formulary decisions on clinical efficacy data; however, data from health outcome studies conducted in real-world settings are becoming an invaluable tool to determine the most cost-effective interventions. Although the emergence of ‘big data’ and growth of sources for observational studies presents a unique opportunity to assess the value of cost-effective healthcare interventions, variability in the research methods and the influence of external factors present challenges in interpretation of data. Another important distinction between a clinical trial and a health outcomes study is the collaboration of teams within industry. Whereas the clinical trial team is aligned with the development team, researchers conducting health outcome studies are usually aligned with commercial functions related to their remit in pricing and reimbursement. Thus, the Health Economic Outcomes Research (HEOR) teams often have only limited exposure to GPP or other publication guidelines. Recently, the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) released the ‘Consolidated Health Economic Evaluation Reporting Standards’ (CHEERS)9 statement to provide guidance in this area for a more consistent and transparent reporting process. Educating HEOR teams on this process, and on GPP2 and other publication guidelines, is necessary to ensure best publication practices.

Another challenge faced by HEOR teams is that the authors/writers are typically the paid vendors (consultants) conducting the research, resulting in the issue of payment made to authors. Payment for health outcome study research theoretically can be considered similar to payment to an investigator for the conduct of a clinical trial, which means this issue should be well-defined in the agreement between the sponsor and consultant, with no additional payment for manuscript authorship. The question of ownership of the data is also debatable, and should also be specified in the agreement. In this era of increasing demand for economic demonstrations of value, medical publication professionals must understand the extent to which HEOR information is being incorporated into clinical papers and review articles—and how these publications are utilized to convey value.

Topic 5: Other challenges and new opportunities for medical publication professionals

The impact of new technologies such as multimedia and social media in medical publications, the use of different business models by agencies, the challenges of budget constraints, and the value of obtaining the ISMPP CMPP™ credential were also discussed at the roundtable sessions.

Every year, new challenges arise for medical publication professionals, with new technologies aimed at addressing these challenges. Advanced multimedia techniques, such as online videos or podcasts on journal websites, can aid in addressing different learning styles. Although multimedia venues for medical publications may blur the line between publication and promotion, a firewall that separates the two should be implemented to ensure ethical guideline compliance and regulation adherence. Quick Response (QR) codes, a type of two-dimensional barcode, can provide links to audio or video when a QR reader is used on a mobile device. Medical publication professionals should be careful when implanting QR codes as there can be a lack of control to the link’s destination and issues if the link becomes outdated. In addition, some conferences, such as the American Society of Clinical Oncology, charge a copyright fee per poster that includes a QR code or any link electronically to the full abstract.

Publishers may use Twitter to attract readers to their websites. Medical publication professionals should remain cognizant that social media is not peer-reviewed or validated, and tweets may be written by individuals hired for product promotion. Publication professionals should refer to their company’s SOPs regarding social media interaction.

Although medical publication agencies can provide many resources for publication planning and development, companies retaining their services should be aware that different agencies may use different business models. The roles and responsibilities of agency staff need to be clearly defined. An agency can serve as a strong partner that understands the company’s strategy and processes and can help train new writers at the company about both scientific content and ethical publication practices. Other agencies may prefer to function as a contractor to perform specific tasks rather than assuming a partnership role.

The quality of work from medical writers can vary and may depend on where the writer is located. Factors such as cultural challenges, which can take time to overcome, are important to consider. Some companies working with a large communication agency may be concerned about having indirect contact with the medical writer. Some authors may not respond well to working with agency writers because of a negative perception of working with a ‘middleman’.

Challenges faced by agencies may include working with the company’s internal medical writers under a reduced fee model, adhering to disparate publication review and approval processes used by different teams within a company, or responding to reduced use of agency services as a cost-cutting measure. Budget constraints seem to be a primary consideration for using freelance writers vs an agency. Companies tend to use agencies for more complex projects, depending on experience, and for local language work. Primary and pivotal trial manuscripts may be kept in-house, whereas secondary manuscripts are sent to agencies.

The ISMPP CMPP™ credential could denote a certain expectation of performance in the medical publication community, although some believe that the certification exam tests the quality of medical writing rather than knowledge of medical publication guidelines. Questions still remain: Do authors and publishers know what CMPP™ means? Do professionals who are CMPP™-accredited have an advantage over those who are not? ISMPP has recently put measures in place to increase access to the exam for individuals living in World Bank-designated low-income countries; however, other attendees still expressed concern that the cost of CMPP™ testing could be a challenge for some who may not be able to afford the exam fee.

New technologies, differing agency business models, budget constraints, and credentialing of the field can have significant impact on the way medical publication professionals operate. Awareness and discussion of these challenges allows medical publication professionals the opportunity to effectively address these items in the future.

Conclusions

The theme of the 9th Annual Meeting of ISMPP was empowering the medical publication community to advance the profession. By hosting open discussions about the concerns and challenges faced by professionals involved in publishing medical data, roundtable discussions raised important questions and proposed practical solutions that can be used to drive best practices in the medical publication professional community.

Transparency

Declaration of funding

The ISMPP Roundtable Session was supported by an educational grant from Synchrony Healthcare Group, LLC, West Chester, PA, USA.

Declaration of financial/other relationships

D.S. is an employee of Cadence Pharmaceuticals, the chair for the ISMPP U committee (2013–2014), and an ISMPP workshop presenter (Alliance Partners and Publication Planning, and Management at Smaller Pharmaceutical/Biotechnology Companies). R.J. is an employee and stockholder of Novo Nordisk Inc. G.N.S. is an employee of Envision Pharma Group. K.S. is an employee of Novartis Pharmaceuticals Corporation. C.W.-H. is an employee of the International Society of Medical Publication Professionals. CMRO Peer Reviewers on this manuscript have no relevant financial relationships to disclose, but have disclosed that they are former members of ISMPP.

Acknowledgments

This report summarizes the discussions from the ISMPP 9th Annual roundtable session and does not represent the opinions of the authors or their previous or current employers. The authors thank Jennifer Ciafullo, MPH, from ISMPP for her invaluable support in developing these roundtable session topics and Sheryl Weinerman of Envision Pharma Group for editorial and formatting support. The authors also thank the Roundtable Moderators: Bea Benoit, Tim Day, Martin Delahunty, Amy Foreman-Wykert, Art Gertel, John Gonzalez, Jackie Gordon, Courtney Leo, Thomas Maliecka, Robert Matheis, Bryce McMurray, Julie Newman, Robert Norris, Kirtida Pandya, Mina Patel, Teresa Peña, Kim Pepitone, Michael Platt, Carol Sanes-Miller, Brian Scheckner, Anca Serban, Beth Sesler, Rachel Sherman, Danita Sutton, Stephanie Tortell, Russell Traynor, Al Weigel, Susan Wingeron, Karen Woolley, and Yvonne Yarker.