Celebrating International Clinical Trials Day in the best way possible

Adapted from the ACTA media release by Lisa Reid

Every May 20th marks International Clinical Trials Day, and our School had an opportunity to celebrate in an extraordinary way this year; two of our major clinical trials were recognised with awards from the Australian Clinical Trials Alliance (ACTA) for their extraordinary contributions to the health and wellbeing of Australians and improvement to the effectiveness and efficiency of the health system.

Associate Professor Robyn Woods from ASPREE, Profesor Anne Kelso, CEO of NHMRC, and Professor John Zalcberg, Chair of ACTA

The overall winner of ACTA’s Trial of the Year award was ASPirin in Reducing Events in the Elderly (ASPREE), an international, multicentre clinical trial to determine whether daily low-dose aspirin prolonged good health by preventing or delaying age-related illness such as cardiovascular disease (heart attack and stroke), dementia, depression and certain cancers in the healthy elderly. It is the largest primary prevention aspirin study ever undertaken in healthy people aged at or above 70 years and the first to weigh the benefits versus the risks.

The trial made international headlines when the primary results were released in September 2018. The results showed that among that cohort, the risks of taking daily low dose aspirin to prevent illness outweighed the benefits.

Associate Professor Robyn Woods accepted the award, saying, "I'm proud to have been involved in such a significant study as ASPREE, and to have led such a fine, talented team of researchers and support staff. It was a huge undertaking that is already seeing real impact in the community, with millions of older people around the world without a clinical need to take aspirin, now able to take one less daily medication."

The Chair of ACTA, Professor John Zalcberg, said, “A treatment that has almost achieved folkloric popularity was proved to potentially do more harm than good, given that aspirin also increases bleeding. While aspirin was viewed as a cheap preventative, the ASPREE clinical trial has the potential to keep people from suffering a known side-effect caused by taking a treatment we now know doesn’t help.

"Clinical trials are vital to ensuring patients receive the best treatments and get the best outcomes. Effective and efficient treatments not only reduce suffering they can also mean less time spent receiving treatment and less money spent by the patient and the health system.”

Professor Anne Kelso, CEO of NHMRC, Professor Paul Myles from the RELIEF trial, and Professor John Zalcberg, Chair of ACTA

Among the finalists for the Trial of the Year Award was the REstrictive versus LIbEral Fluid Therapy for Major Abdominal Surgery (RELIEF), run by The Australian and New Zealand College of Anaesthetists Clinical Trials Network, housed within our School. RELIEF was also the highest ranked NHMRC project grant in the 2012 funding round.

Every year at least 310 million people undergo major surgery worldwide, and they all receive intravenous fluids – generally receiving up to seven litres on the day of surgery. The RELIEF team believed existing evidence for fluid restriction during and immediately after abdominal surgery was inconclusive. They were concerned that fluid restriction could increase the risk of hypotension and decrease kidney and other vital organ perfusion, leading to serious complications after surgery. It also meant that more patients might require admission to the intensive care unit after surgery because of haemodynamic instability – adding expense and complexity.

Professor Paul Myles, Chief Investigator said, “Our international study clearly demonstrated that fluid restriction did not reduce complications or improve recovery after surgery. Importantly, we found that fluid restriction damaged the kidneys and increased the risk of wound infection. This simple intervention – administering moderately liberal IV fluids during and after surgery – is the first proven prophylaxis to prevent kidney damage after surgery. This new information can better inform not only anaesthesiologists and surgeons, but also junior doctors on the wards. This will change practice around the world.”

International Clinical Trials Day – 20 May – is held annually on the day James Lind started his study to determine the cause of scurvy in 1747. Lind selected 12 sufferers of scurvy and tested different dietary additions to the group in pairs; a garlic mustard and horseradish mixture, cider, vinegar, seawater, oranges and lemons. The recipients of the citrus fruits recovered within a week, definitively establishing the effectiveness of citrus fruits in treating scurvy.

Congratulations to all personnel from the ASPREE and RELIEF studies – what an amazing accomplishment.

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