Ethical implications of poor comparative effectiveness evidence: obligations in industry-research partnerships

Abstract

Which treatment is best for me? This question is at the centre of the clinical consultation. And yet, too often, the question is not answerable with available evidence on drugs and devices. The two Lancet Series papers on comparative effectiveness 1 , 2 document the shortcomings of the process for regulatory approval in incentivising the generation of comparative effectiveness evidence that is useful for patients, clinicians, and the health-care system. The paucity of meaningful comparative data on drugs and devices before and after market entry compromises clinical decision making. We argue that measurable ethical obligations to patients should form the core of future comparative effectiveness research in an era of personalised medicine.