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What can be done to increase the transparency of real world studies?


KEY TAKEAWAYS

  • Pharmaceutical companies, researchers, publishers, and medical publication professionals all have a role to play in increasing the transparency of real world data generation and dissemination.

Despite growing interest in real world (RW) evidence throughout the pharmaceutical sector, transparency surrounding generating, reporting and using RW evidence is not regulated, and clear guidance on best practice is lacking. This is the premise behind a recent perspective by Dr Remon van den Broek et al in Health Economics, Policy and Law, which outlines the results of roundtable discussions between pharmaceutical companies, academia and other stakeholders, including the International Society for Medical Publication Professionals, on RW transparency issues and proposes potential solutions.

“A truly transparent healthcare sector will only evolve if all stakeholders increase their efforts and bring about tangible changes resulting in greater transparency surrounding the generation and reporting of RW studies.”

As a first step to improve openness, the authors suggest adopting universal definitions for RW studies, RW data and RW evidence, with the latter defined as RW studies that have been publicly communicated or assessed for relevance and quality.

Additional recommendations for industry, researchers, decision-makers, and other involved stakeholders include:

  • engaging patients/caregivers in defining RW outcomes of interest and ensuring the engagement process is transparent
  • mandatory registration of RW studies and their protocols, with results of RW studies made available within 1 year of study completion
  • dissemination of RW studies through peer reviewed publications, with manuscripts prepared clearly and transparently and according to the most relevant methodology guidelines
  • journals expanding their expertise to provide appropriate peer review for RW studies
  • development of a RW-specific communication reporting checklist
  • provision of open access lay summaries of RW studies in journals
  • use of appropriate methodology and good assessment practices by healthcare decision-makers during the drug approval/appraisal process to ensure accurate evaluation of RW evidence
  • closer collaboration of regulatory agencies with patient communities during decision-making processes.

The authors believe that “a truly transparent health care sector will only evolve if all stakeholders increase their efforts and bring about tangible changes resulting in greater transparency surrounding the generation and reporting of RW studies”.

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What do you think - should the transparency of real world evidence more closely match that expected from clinical trials?

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