Clinical effectiveness research: a critical need for health sector research governance capacity

The barriers to conduct of clinical research will require solutions if we are to implement evidence-based health care reform

Reforms in the funding of health services, such as “activity-based” funding initiatives, seek to facilitate changes in how health care is delivered, leading to greater efficiency while maintaining effectiveness. However, often these changes in treatment strategies and service provision evolve without evidence demonstrating effectiveness in terms of patient outcomes. The pressures on health care expenditure (currently around 9% of gross domestic product1) make such an approach untenable and unsustainable. The evidence necessary to support these initiatives can only be derived through carefully conducted clinical research. Most readers would immediately think of clinical trials in terms of pharmaceuticals or clinical devices, and this type of research is critically important, although continuing to decline, in Australia.2 Other questions relate to the effectiveness of changes in health practice or policy, usually (but not always) based on sensible ideas that seem self-evident. However, in order to function with an evidence base, these ideas need to be proven to be clinically effective and cost-effective. Such research can be costly, and many of the questions to be addressed are not ones that would be the subject of an industry-sponsored trial. Researchers, clinicians and health administrators are therefore faced with the problem of how best to measure the outcomes of changes to health care strategies, without the necessary resources to ask and answer the question.