Regional Reports

New ACTA’s Unexpectedly Positive Global Impact

Richard Day
DIA Fellow
Global Forum
Australia/New Zealand Regional Editor


he recently established Australian Clinical Trials Alliance (ACTA) is having an unexpectedly positive impact in Australia and globally.

ACTA has the very laudable aim of promoting “effective and cost‐effective healthcare in Australia through investigator‐initiated clinical trials and clinical quality registries that generate evidence to support decisions made by health practitioners, policy‐makers, and consumers.” The rationale is compelling, namely “Many clinical decisions in medicine are still based on either low quality evidence or no relevant evidence at all.” Further, ACTA argues that “public good,” “investigator-initiated” clinical trials are needed to address important gaps in our knowledge.

ACTA’s landmark report on the Economic evaluation of investigator-initiated clinical trials conducted by networks, produced in partnership with Australian Commission on Safety and Quality in Health Care and reported August 2017, revealed that the return on investment approaches A$6 for every A$1 expended on investigator-initiated trials. The study evaluated only 25 trials that produced results considered “sufficiently scientifically rigorous and compelling to change clinical practice.” They were undertaken by three dedicated Australian clinical trials networks – viz., intensive care, stroke and maternal and perinatal care clinical trials networks – and involved over 50,000 people. If just two-thirds of eligible people were treated according to the research findings for just one year, savings approaching A$2 billion would be realized, mostly due to better and safer health outcomes.

Over 40 organizations and networks are now ACTA members, including the internationally outstanding Australasian Kidney Trials Network and the National Health and Medical Research Council Clinical Trials Centre. These established clinical trials networks have been extremely successful in improving health outcomes and saving scarce resources for our health system. The synergies already evident via ACTA promise an exciting acceleration of accrual of new evidence that will transform health care.

By way of example, The ACTA Trials of the year were announced at the Clinical Trials 2017 National Tribute and Awards Ceremony. The winner was a global study in over 4,600 participants in 31 hospitals throughout seven countries led by the Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA CTN). The Aspirin and Tranexamic Acid for Coronary Artery Surgery (ATACAS) Trial examined the safety of aspirin and tranexamic acid in open-heart surgery. Second was the Interdisciplinary Maternal Perinatal Australasian Collaborative Trials (IMPACT) Network study of the costs and benefits of oxygen saturation in the BOOST II Australia Trial performed in very premature infants. Third was the Enhanced control for hypertension and thrombolysis stroke (ENCHANTED) Study led by the Australasian Stroke Trial Networks and coordinated by The George Institute for Global Health. This study recruited from more than 100 centres worldwide and showed that lower doses of clot-busting drug rtPA were effective and safer for patients with acute stroke.

The Excellence in Trial Statistics Award recognizes the vital contribution of specialist trial statisticians. This award went to the Sleep Apnea Cardiovascular Endpoints (SAVE) Study led by the Australasian Sleep Trials Network & Adelaide Institute for Sleep Health, and coordinated by The George Institute for Global Health. The study in almost 3000 patients from nearly 100 hospitals globally found that positive airway pressure does not reduce the risk of heart attacks and recurrent strokes for people with established cardiovascular disease.

For the first time in Australia, ACTA provides a single and coordinated channel for Australian clinical researchers to interact with Governments, policy makers, industry, colleges, insurers, patients, and consumers on matters relevant to conducting public interest clinical trials of relevance to all Australians. ACTA is already having a significant impact in Australia–and much more is anticipated globally.

References available upon request.