There is an opportunity to transform New Zealand healthcare systems that would make them world leading, efficient and better for patients. This new opportunity is made possible by standardised electronic medical information (EMRs). The transformation involves integrating research into service provision. By integrating research into service provision our health systems can use medical records to systematically improve the quality of care, save on costs and reduce health disparities between our populations. In effect, our health systems can learn.

There are 3 main requirements to generate meaningful data that can guide clinicians: (1) Trial sample sizes must be (much) larger, as ‘improvements in existing standards of care are likely to be incremental (10%-25% relative reduction in events), and large studies with numerous events are needed to identify moderate treatment effects’; (2) Secondly, the trials must be simple, to reduce cost of conducting them; (3) Lastly they must contain randomisation.

For the purposes of this talk I only consider researching established standards of care. This means that these trials involve features of experimental research (randomisation), but the interventions themselves are not experimental and there is no use of a placebo. Research that evaluates standard of care interventions is called comparative effectiveness research and is defined as “the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings”.

I demonstrate that under the current regulatory and ethical paradigm it is difficult, if not impossible, to conduct such large, low cost intervention studies. I contend that for research involving standards of care we must revisit the level of regulation, oversight and our ethics framework – to ensure we continue as a country to protect participants while facilitating important health research.