Sandra Farley, ISMPP CMPPTM, Bristol-Myers Squibb; Alan Hempel, PharmD, JD, Bristol-Myers Squibb
Patients have common and unique needs throughout the world. Global publication planning and execution is critical to ensure relevant data are available to health care providers (HCPs). Publication planning professionals need to be in lockstep with international colleagues to make sure publication plans are prepared and executed in an inclusive manner. To accomplish this, it is imperative to ask key questions, create a living publication plan, and communicate clearly and often.
Ask Key Questions
It is important to understand global and local needs in order to create a comprehensive plan. Discovery sessions with international colleagues can be helpful. Examples of useful questions for colleagues to ask each other include:
Planning
- What are global and local publication objectives?
- On global studies, are there local candidates for publication authorship?
- Has a needs assessment been conducted to determine unmet needs?
- Are local language publications necessary?
- Might data presented at an international congress be appropriate for translation and encore presentation locally?
- Are physicians in a specific area less likely to attend global meetings?
- Is an abstract author available to present, or does the congress allow for non-author presenters?
- When is the corresponding full manuscript slated for publication?
- What questions are local HCPs asking that a publication might address?
Cross-Matrix/Medical Alignment
- What global and regional data are available now, and what data will be available in the future?
- Are subanalyses of global data planned or underway that would help HCPs understand unique local demography or access/cost challenges?
- Can future global studies be powered to look at regional data cuts?
- What are regional regulatory needs?
- Are studies conducted on local patients required?
- When will a therapy be approved locally?
- For regulatory purposes: Must data be presented in a journal that includes page numbers and/or is citable or readily available in order to be considered valid?
Operations
- Are there local budget constraints? Can this be solved with global monies or resources?
- Do those in the regions have multiple job functions within the medical department? If so, can other resources be shared?
- What are individual roles and responsibilities in terms of execution?
- Who is routing drafts to document the process for authorship contribution, review, and approval?
- Who will follow up with authors and how?
- Who will provide scientific accuracy review of the publications, and will this differ based on language and content?
Create a Living Publication Plan
Once you have asked and shared and listened, begin putting pencil to paper. Consider a slide with a GANTT chart that is easy to modify. It may include global data, regional data, subanalyses of global studies, health economics and outcomes studies, and encore publications. A slide for each region with a “snapshot” slide at the end can be useful. (See Figure.)
It is important to plan these publications in advance and capture them on the global publication plan to avoid duplication, while ensuring local needs are being met. Because each country is unique, each country’s publication plan should be focused on addressing the local gaps for new medical data. A literature assessment of published data in local languages might help to identify gaps that publications with new data cuts or review articles could fill.
As gaps are filled, new ones arise. Therefore, plans should be updated regularly to reassess needs and realign with the global publication plan. The publication plan should be accessible to all stakeholders. Consider housing it on Sharepoint or within a publication tracking tool.
The publication plan can change frequently throughout the year based on local environments, data availability, delayed or expedited publication timelines, etc. It is essential to communicate regularly to make sure the publication plan still makes sense.
Communicate Clearly and Often
Getting to know colleagues, understanding cultural differences, and learning nuances in communication are useful when communicating internationally. Defining roles and establishing expectations can help to avoid misunderstandings.
Understand communication style. Consider email vs telephone when there is a language barrier. A clear and succinct email allows time for interpretation and careful response by colleagues. An affirmative answer may be a polite response, but not an accurate answer. Be careful in how questions are phrased. “Can we get this done by Wednesday?” may be interpreted different ways. A “yes” reply could mean any of the following: I understand what you want and I’ll get it done by Wednesday; It’s possible, but I’m not sure what you want me to do; I didn’t understand the question, but I’ll try being agreeable.
Explaining publication “words of art,” key phrases, and commonly used acronyms and abbreviations can also help to avoid miscommunication. Unless defined in the context of publications, an “encore” may mean nothing more than another performance by an opera singer. And GPP can be Good Pharmacovigilance Practice, General Practitioner Protocol, Gabinete de Planeamento e Politicas?
Accommodate local time zones when possible. If a meeting must be scheduled outside of local business hours, ask if your colleague prefers evening or early morning meetings. Be sensitive to regional holidays and observances.
To support authors in publishing medical data worldwide, planning requires careful alignment with local, regional, and global needs. Without alignment, there is a potential for misreporting or misinterpretation of data, which hinders rather than fosters medical knowledge of HCPs.