Nobody doubts the need for compliance in medical publication planning and execution. However, the recent 8th Annual Meeting of the International Society for Medical Publications Professionals (ISMPP) in the US also aimed to provide attendees with practical solutions to aid efficient and effective publication planning in what has become an increasingly complex environment. Topics covered included methods to quantify and ensure author involvement, including those with language barriers, improvement in publication timelines, effective collaboration between industry and publishers, new publication models and technologies, as well as the need for not just transparency, but also clarity in communication.
Corporate integrity agreements
Increasingly, medical publication professionals are being affected by the fact that US-based companies, or the US affiliates of global companies, are being placed under corporate integrity agreements (CIAs), which include mandates relating to publication practices. Although a CIA is a binding agreement made between a US company (or US affiliate) and the US Office of the Inspector General (OIG), publications and publication planning are impacted both inside and outside the US.
In an effort to streamline global processes and work in a compliant manner worldwide, many companies under CIAs are putting in place a single global Standard Operating Procedure (SOP) to ensure that all company-supported publications are developed according to the same high standards.
So what is the situation with medical publication planning in 2012? Consider the following:
This all points towards the need for publication planning to be more globally-orientated than ever before.
Transparent, clear, accessible
So how does a publication professional ensure that the publication plan is meeting the need to be truly global in scope and communicating effectively with readers?
As mentioned, in recent years the primary focus of individuals working on medical publication programmes has been to ensure the transparency of all activities and publications undertaken by the team. This has included ensuring appropriate authorship, acknowledgement of all non-author contributors, conflict of interest disclosures, plus ensuring publication and/or disclosure of all clinical data as appropriate.
Compliance and transparency remain vital and the profession should view them as the bedrock of all it does. However, in the midst of ensuring full compliance, the actual art of delivering an efficient and effective publication programme has been almost forgotten.
On the foundation of compliance and transparency, publication programmes must be built that run efficiently and produce outputs that clearly convey the data and its clinical relevance, including any risks, to the appropriate audience.
One of the panel discussions at the recent ISMPP meeting focused on what end users of publications really want from the publications they read. The panel featured a wide range of stakeholders including a patient representative, a medical librarian, a journal editor and a payer representative. In a distilled form, what people actually want from medical publications is actually very simple and listed in the box:
The rise of open access publishing was reviewed in PME in the article 'Access granted' (PME July/August 2010) and this has further gathered pace in the two years since. Physicians, and other readership groups, need and want to be able to access information at any time and anywhere, and for free. More and more journals and publishers are turning towards open access, and this is particularly important in developing countries where the readership may well not have access to traditional print journals, or the funds to be able to purchase them.
Moving forwards, it must be ensured that the readers are able to find the information they need and for that information to be written and communicated in a manner that facilitates understanding of the information across different languages, cultures and levels of education. The writers of these publications, be they contributors or authors, should write at an appropriate level for their audience and with sufficient clarity to ensure that the information they are conveying is not just disclosed, but is understood in the appropriate context.
Efficient and Compliant?
One of the dangers of focusing purely on compliance in a publication programme is that good project management is overlooked, the programme becomes less efficient and publications are not developed and published in a timely manner. Ironically this defeats one of the aims of a compliant programme, which is to disclose data as quickly as possible following study completion. With the increasing influence of budget constraints, it is important that the publication team maintains good project management in all aspects of its work, to achieve publication of information in an efficient and effective manner that does not waste time and resources and ensures that information reaches the readership quickly.
Top tips for efficiency in publication programme management:
In summary, the profession must maintain compliance and transparency as the core of how it acts, and then build time- and budget-efficient publication programmes that utilise appropriate publication models to reach all of the global readership with information that is written with scientific accuracy and clarity, while engaging the reader.
Russell Traynor (left) is director, business solutions at UBC-Envision Group and chairman of ISMPP. Sarah L Feeny is global head of scientific direction at Complete Medical Communications and European-At-Large Trustee of ISMPP. The views expressed in this article are those of the authors and do not necessarily reflect the official views of ISMPP, UBC-Envision Group or Complete Medical Communications.