OBJECTIVES: Unlike the pre-planned/pre-approved analyses of randomized controlled trial data (for which publications are guided by well-established good practice guidelines), HEOR/RWE analyses can continue to evolve from inception to publication without the facility of specific best practice guidelines (BPGs) beyond existing checklists for data reporting. This pilot study surveyed stakeholder attitudes and perceived challenges for the ethical and efficient publication of HEOR/RWE, and the need for BPGs in this space.

METHODS: A LinkedIn post published during February 2023 invited publication professionals and HEOR/RWE collaborators to respond to an 8-question online survey pertaining to user type, experience, publication difficulties/reasons/approaches for potential mitigation, incidence/reasons for cancelled publications, and BPG needs.

RESULTS: Amongst the 24 respondents, the length of HEOR/RWE experience ranged between 1−20 years (mean[SD], 8.2[6.0]); 9 with ≥10 years’ experience. Current roles included: associate-/director or higher (n=14), publications manager (n=5), HEOR consultant/medical writer (n=5). Amongst the total, 22 (91.5%) in total who in totality experienced 36 discrete types of publication difficulties, these related to data issues/interpretation (n=20), insufficient resourcing (n=5), journal-related issues (n=5); lack of sponsor team alignment (n=3), and third-party issues (n=2). Of 24 respondents, 8 (30.0%) indicated publication cancellations from difficulties/delays caused. Twenty (83.3%) responded that publication difficulties or delays could have been mitigated, with 25 discrete recommendations provided, including 10 proposals around earlier data pressure-testing prior to publication preparation. All respondents indicated a need for HEOR/RWE publications BPG.

CONCLUSIONS: To allow for timely inclusion into evidence dossiers, the dissemination of HEOR/RWE through peer-reviewed channels must be done rapidly, without compromising efficiency or ethical publication practices. Considering the ever-changing nature of such inputs as drug prices and standard of care, delays may render the research obsolete. This pilot survey highlights the many challenges faced in HEOR/RWE publications development and the need for BPGs; more research of stakeholder insights is warranted.