The key fundamentals of publication planning are to deliver the right data to the right audience at the right time. For pharmaceutical companies, publication planning is primarily based on the clinical study programme to ensure data are reported in a timely manner, as per guidance from the United States Government and European Commission. Key considerations are often based on authorship (“who”), timing (“when”), and journal/conference selection (“where”). However, publication planning is evolving to address different data demands as the landscape of healthcare decision makers is shifting to involve a range of stakeholders (including physicians, payers, patients and policy makers). In an article for Medical Writing from the European Medical Writers Association, Richard White (Chief Operating Officer, Oxford PharmaGenesis) provides his thoughts on publication planning in a multi-stakeholder era and the importance of patient reported outcomes (PROs).
White emphasises that publication planning must look beyond clinical benefits to utilise all available evidence (including economic, social, behavioural and policy) to demonstrate the full value of a health intervention. In this regard, PROs are essential; however, White notes that the drive for “real world evidence” and “big data” has led to a focus on routinely collected data from healthcare databases which often do not include PRO assessments or the patient voice.
As well as providing insights into clinical assessments, White comments that PROs are important to understand how a disease and potential treatments can impact patients and caregivers from a social and behavioural perspective. It is becoming increasingly common for both patients and caregivers to access specialist literature directly, which brings a wealth of opportunities but also poses several challenges.
To help capitalise on the opportunities and limit the challenges, White provides some guidance/best practice tips for PRO publication planning:
- Identify which PRO data can be published and the associated publication opportunities, such as: systematic literature review; patient/physician focus groups and cognitive interviews; validation study; clinical trials incorporating PRO endpoints.
- Engage with the right authors; for example, clinicians and patients/caregivers to help communicate the clinical relevance of the PRO data.
- Target appropriate mainstream conferences and open access journals to reach physicians, patients, payers, and other decision makers.
- Publications for PRO studies should be written in a clear and engaging way and follow applicable reporting standards (such as CONSORT-PRO).
- Supplementary information or enhanced publication options (such as plain language summaries or explanatory videos) should be used to increase reach, comprehension and impact.
To end his article, White quite rightly reminds us that any studies involving patients should always acknowledge and thank them for their contributions to the study: “A short statement in the Acknowledgements section of a conference presentation or journal article is simple to do, but will be hugely valued”.