Integrated health outcomes research strategies in drug or medical device development, pre- and postmarketing: time for change

Abstract

The implementation of health outcomes research as a healthcare decision-making tool has expanded rapidly in the last decade. Drugs and medical devices are increasingly being required to demonstrate not only their efficacy and safety characteristics, but also their performance in at least three core dimensions of health outcomes research: clinical effectiveness, patient-reported outcomes and economic outcomes. However, the current integration of health outcomes research lacks coordination and communication and as a result, money and time is being spent on the generation of health outcomes research data which can be both insufficient and fail to satisfy the information demands of all the relevant stakeholders. In response to this, a new paradigm is evolving which involves the implementation of health outcomes research strategies that encompass the development, pre- and postmarketing stages of a drug or medical device.

• clinical effectiveness
• drugs
• economic outcomes
• health outcomes research
• market access
• medical device
• patient-reported outcomes
• pricing and reimbursement