The case for one global SOP for medical publications
As medical publishing becomes increasingly global, it makes sense to institute one standard operating procedure to maintain consistency in all markets. However, with budget constraints and regional differences, this is not an easy task.
In recent years, medical publishing, including that reporting on pharmaceutical studies, has become ever more global in nature. Industry-sponsored phase II and III sites have shifted from being predominantly located in North America and Western Europe to Eastern Europe, Latin America and the Asia-Pacific regions. At the same time there has been a steady increase in the number and proportion of biomedical publications coming from emerging markets.
As a case in point, since launching its Asia-Pacific programme, The International Society for Medical Publication Professionals (ISMPP) has received over 625 registrations for the four Asia-Pacific-focussed webinar programmes it has run, and over 40 individuals from the Asia-Pacific region have attained ISMPP's Certified Medical Publication Professional (CMPP) status.
It is widely acknowledged that English remains the language of choice for medical publications, and the majority of authors, wherever they are located, would prefer to have their articles published in English-language (international) journals. Indeed, in a number of countries (e.g. China) scientists are given incentives to publish their research in prestigious English-language journals.
Alongside this, US-based companies, or the US operating companies of ex-US headquartered companies, are being put under corporate integrity agreements (CIAs) that include stipulations regarding their medical publication practices. While the agreements are only directly relevant to a US company or the US affiliate, given the global nature of clinical trials and the resulting publications, in reality the impact is global. This has led to many companies adopting a one policy and standard operating procedure (SOP) approach for medical publications that is globally applicable.
Benefits of a single SOP
There are significant benefits to this approach:
• Consistent and compliant author engagement approach
• Consistent release processes to ensure protection of intellectual property
• Consistent and accurate communication of datasets and products' evidence strategy
• Global visibility of global, regional and country-based planned publication activities to avoid duplication and redundancy and data not being published at all
• Global auditability, enabling the demonstration of good working practices
• Powerful cross-regional and country metrics capabilities, bringing efficiency and effectiveness improvements across the company
In addition, utilising one SOP across the whole company ensures that roles, responsibility and accountability are clearly defined, which promotes compliance and enables the company to better support individuals undertaking publication-related activities.
Facilitating a single SOP
Aligning all countries and functional areas within a global pharmaceutical company to work to the same process and policy for medical publications is a significant undertaking for any company.
The trend towards leaner resourcing means that it is unlikely that there will be a dedicated publication resource in each country and, even if there is, there will be other country-specific requirements competing for their time. Furthermore, the fact that many of the US requirements may not be mandatory in many countries outside the US may deprioritise their completion. These factors, combined with cultural differences, may make implementation of a global policy challenging.
It makes sense, therefore, to keep SOP high level, covering only the required elements. In addition, an SOP that will be applied to all central teams and affiliates across all functional areas should focus on areas of similarity i.e. where alignment can be achieved and the most value gained, rather than focusing on specific country or cultural differences. The details can be defined in a series of working guides developed for each country or region.
External best practices and standards, such as the International Committee of Medical Journal Editors (ICMJE) Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals and the Good Publication Practice 2 (GPP2) Guidelines developed by ISMPP should serve as a benchmark; aligning the Global SOP with these will provide an internal reference point, ensure the company's approach is consistent with industry best practices and help facilitate effective communication of the required procedures with external authors.
"It will be necessary to have a system that has workflows, data fields and reports that can be configured to support the SOP"
In order to realise the benefits of a global approach as well as being able to monitor and demonstrate compliance with the SOP, it will be necessary to have a system that has workflows, data fields and reports that can be configured to support the SOP. Such a system should:
• Allow the global publication plan and outputs from the plan to be 'visible' to all relevant stakeholders
• Facilitate efficient project management to allow the SOP to be followed without placing unnecessary, additional, administrative burden on staff
• Ensure the correct steps are followed and appropriate data are captured, enabling both compliance auditing and internal metrics programmes to be undertaken
In summary
The continuing globalisation of clinical research and resultant publications, together with their increased accessibility via the internet, has led to many companies to consider a single global process. However, differences in culture and local regulatory requirements, as well as limited local resources, may make implementing a single SOP, applicable around the globe, challenging for company-sponsored medical publications.
Companies that have successfully made this transition have kept the SOP focused on critical and mandatory aspects of publication planning and development, aligned the SOP with industry and academic best practice, and put in place a system to support the SOP globally across all functional areas.
The views expressed in this article are those of the author and do not necessarily reflect the official views of Envision Technology Solutions.
About the author:
Russell Traynor, BSc, MSc, is Business Lead, Envision Technology Solutions. He works with clients to identify and implement effective technology solutions to meet their needs.
Russell has worked in medical communications and publications since 1997, as a medical writer, account lead and business consultant.
He regularly presents and publishes articles on topics in the field.
Russell served on ISMPP's Board of Trustee for five years, and was the chairman of ISMPP, 2012-2013.
He is an ISMPP Certified Medical Publication Professional (CMPP).
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