While clinical trials are used to test how effective and safe medicines are in controlled settings enabling regulators and payers to decide upon which medicines to register and subsidise for the general public, in Australia, there have been crucial gaps in knowledge that give reliable evidence of how these medicines translate to the ‘real-world’ in terms of their use and effects, until now.

With the use of Australia’s growing data ecosystem, real-world data will soon be able to identify, triage and respond to questions where there are uncertainties about a medicine’s use, cost-effectiveness, and potential harm.

The Medicines Intelligence Centre of Research Excellence (MI-CRE) has developed a co-ordinated research program to help fill these crucial gaps in evidence from clinical trials. They have

  • Created an enduring data infrastructure with the capacity to answer comprehensive questions about the use, benefits, and risks of medicines in real-world settings.
  • Developed a strategy to engage with policymakers and other medicines intelligence end-users to break down barriers around the use of real-world evidence.
  • Created training opportunities to equip the next generation of medicines intelligence researchers in Australia with the skills to co-create actionable evidence with end-users.

MI-CRE was established to support decision making needs of the Australian medicines policy agency decisions by accelerating the development of real-world evidence. The collaborative research program brings together investigators based across nine Australian universities and scientific advisors from six leading international academic institutions. Together, they generate evidence to support the needs of medicines policy agencies.

An article published in the International Journal of Population Data Science (IJPDS) details the growing importance of real-world evidence for medicines regulators and payers globally, and the historical challenges in generating comprehensive and timely evidence on real-world medicine use and outcomes. It details how MI-CRE has responded by developing a multi-faceted approach to generate and translate high-quality evidence to support access to safe and effective medicines for the Australian community.


You can read the full results of this study here

Nicole Pratt, Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia

Pratt, N., Camacho, X., Vajdic, C., Degenhardt, L., Laba, T.-L., Hillen, J., Etherton-Beer , C., Preen, D., Jorm, L., Donnolley, N., Havard, A. and Pearson, S.-A. (2021) “The Medicines Intelligence Centre of Research Excellence: Co-creating real-world evidence to support the evidentiary needs of Australian regulators and payers.”, International Journal of Population Data Science, 6(3). doi: 10.23889/ijpds.v6i3.1726.