Trial of Year winners announced


Australian Clinical Trials Alliance celebrated International Clinical Trials Day by recognising the extraordinary contribution of investigator-led trials to the health and wellbeing of Australians and improvement to the effectiveness and efficiency of the health system.

“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,” said Prof John Zalcberg, Chair of ACTA.

“There are treatments in regular use that are not fully supported by evidence, and investigator-led clinical trials are important in testing assumptions and making sure we are providing the most effective treatments,” Prof Zalcberg said.

The Clinical Trials 2019 National Awards gives us a great opportunity to get together and celebrate some of the great work that has taken place in Australia, or led from here, including:

· A trial that answered the question of whether an aspirin a day really keeps the heart attack away.

· A trial that will lead to a complete revision of international guidelines and change abdominal surgery practice around the world

· A trial that will improve recovery time for survivors of septic shock and see them spending less time in intensive care units

· A trial that embraced consumer recommendations and support to help clear the way to prove the best treatment for saving preterm babies

“The winner of the 2019 Trial of the Year award is the ASPREE Trial, which looked at the efficacy of people 70 and above taking aspirin daily in preventing age-related illness including heart attack and dementia,” said Prof Zalcberg.

“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.”

The ADRENAL Study was a Finalist for Trial of the Year and took out the STiNG Award for Excellence in Trial Statistics.

“As well as proving that hydrocortisone reduced the severity and duration of shock, lowered time on life support and meant shorter hospital admissions, the ADRENAL study was the first Australian ICU trial to be included in the Portfolio of the National Institute of Health Research, UK, facilitating UK resource support. The ADRENAL team also developed and manufactured a GMP-licensed internationally exportable parenteral placebo formulation, creating a valuable resource for future triallists,” Prof Zalcberg said.

This year saw the creation of a new award for consumer engagement and involvement with consumers. The winner, the TORPIDO 30/60 study wanted to determine which initial concentration of oxygen should be given to preterm babies in the delivery room. The team invited consumers to be involved in the design of this trial to assist with ideas to alleviate parental concern and increase the number of babies entered in, and benefiting from, the trial.

Professor Anne Kelso, CEO of National Health and Medical Research Council (NHMRC) was keynote speaker at the event.

2019 Trial of the Year Winner


ASPirin in Reducing Events in the Elderly

ASPREE (ASPirin in Reducing Events in the Elderly) study was an international, multicentre clinical trial to determine whether daily low-dose aspiring 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 aspiring study ever undertaken in healthy people aged at or above 70 years and the first to weigh the benefits versus the risks.

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.”

2019 Trial of the Year Finalist


ADjunctive CorticosteRoid TrEatment iN CriticAlly ilL patients with septic shock

Steroids are commonly used drugs in medical practice for a variety of conditions. Whether hydrocortisone improves survival in patients with septic shock was unclear.

The ADRENAL study was developed to determine if hydrocortisone, compared to a placebo, reduces 90-day-all-cause mortality in patients admitted to an ICU with septic shock.

Lead author of the ADRENAL study Professor Bala Venkatesh, of The George Institute, said: “It’s a great honour to be a finalist in these prestigious awards. Sepsis does not discriminate and around a quarter of people with the disease will die. And many more will be left with life-long disabling conditions such as amputations.

“This award will help raise much needed awareness about sepsis. It also highlights the importance of such trials as ADRENAL that are enabling us to

/Public Release.