Clarity, transparency and inclusiveness are among the principles that should inform the design and conduct of comparative effectiveness research (CER) in healthcare, argue researchers from industry and academia.
With momentum building in the US and other markets for CER as a tool for cost-constrained health systems to clarify product value, an international group of researchers has come up with a set of voluntary principles to encourage more consistency in the way CER is planned and carried out.
The principles were published in the September issue of The Journal of Comparative Effectiveness Research and highlighted by the National Pharmaceutical Council, a health-policy research organisation with headquarters in the US and support from the country’s leading research-based pharmaceutical companies.
The research group that developed the guidance looked at existing health-technology assessment principles and sought feedback from multiple CER experts and other stakeholders.
The resulting 13 principles include:
• Ensuring research objectives are clear
• Transparency in research conduct
• Involving stakeholders, and especially relevant decision-makers, in a meaningful way throughout the research process
• Considering the perspectives and interests of a wide range of stakeholders
• Using relevant comparators
• Evaluating relevant outcomes and the impact of individual treatment effects on patients.
The researchers acknowledge in their paper that “no one study will necessarily be able to fully meet every principle to the letter” but believe CER should always try to fulfil, and never ignore, the intent of the guidance.
“For CER to succeed in guiding health decisions, it should be planned and conducted with rigour and transparency,” said lead author Bryan Luce of United BioSource Corporation and the University of Washington.