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Clinical Trials 2019: National Tribute and Award Ceremony

We started International Clinical Trials Day with a bang, celebrating Australian achievements in Clinical Trials with a breakfast ceremony at the Royal Children’s Hospital Melbourne. We rang in the occasion with Keynote speaker Professor Anne Kelso AO—the CEO of the National Health and Medical Research Council (NHMRC). Professor Kelso has made many contributions to the health sector, initially as a biomedical researcher, and then by advancing the discipline of immunology more broadly as a communicator. Professor Kelso addressed a captivated crowd as she spoke about the essential nature of clinical trials as a tool to advance the health industry.

Congratulations to ACTA Trial of the Year Winner – the ASPREE study. They turned out in force with a tribe of trialists headed by Associate Professor Robyn Woods and some words of wisdom offered by their consumer representative on the day, Emeritus Professor Bruce Holloway. 

The winner of this year’s 2019 Trial of the Year was the ASPREE study
Led by:    Monash University, Department of Epidemiology and Preventative Medicine
Coordinated by:     ASPREE Clinical Trial Co-ordinating Centre

The ASPREE (ASPirin in Reducing Events in the Elderly) study was 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, dementia, depression and certain cancers in the healthy elderly. It is the largest primary prevention aspirin study ever undertaken in healthy people aged 70 years or above and the first to weigh the benefits versus the risks. 

Associate Professor Robyn Woods, accepting the award said, "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 Finalists
ADRENAL 

ADjunctive CorticosteRoid TrEatment iN CriticAlly ilL patients with septic shock
Led by:
 ANZICS Clinical Trials Group
Coordinated by: The George Institute for Global Health.    
Steroids have been used for decades by some clinicians to treat patients admitted to an ICU with septic shock, but whether such treatment improved survival was unclear. The ADRENAL study was conducted to determine if hydrocortisone, compared to a placebo, reduces 90-day-all-cause mortality in patients admitted to an ICU with septic shock. 

RELIEF
REstrictive versus LIbEral Fluid Therapy for Major Abdominal Surgery
Led by:
ANZCA CTN – Australian and New Zealand College of Anaesthetists Clinical Trials Network  
Coordinated by: Department of Anaesthesia and Perioperative Medicine, Alfred Hospital, Melbourne

Every year at least 310 million people undergo major surgery worldwide, and they all receive intravenous fluids – generally receiving up to 7 litres on the day of surgery. The RELIEF team believed existing evidence for how much fluid to administer 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 but too much fluid could cause pulmonary oedema and other complications of fluid overload. The RELIEF study provides high quality guidance to clinicians about how much fluid therapy is optimal.

2019 ACTA STInG Excellence in Trial Statistics Award Winner
ADRENAL 
ADjunctive CorticosteRoid TrEatment iN CriticAlly ilL patients with septic shock
Led by:
   ANZICS Clinical Trials Group
Coordinated by: The George Institute for Global Health  

The design of ADRENAL resulted in several firsts for the Australian ICU network –
–    Randomisation was performed using a minimisation algorithm via an encrypted web-based interface, stratified according to participating site and an operative or non-operative diagnosis on admission to the ICU
–    A detailed analysis plan was pre-published in Critical Care and Resuscitation, one of the leading journals in critical care medicine in Australia
–     The statistical analyses used, including competing risk analysis, multiplicity adjustments
All pre-specified and post-hoc analyses were transparently reported in the NEJM publication.

Associate Professor Billot said: “We knew that the ADRENAL trial was likely to have substantial impact. Our goal was to make sure the statistical analysis was as ‘robust’ as possible. In particular, we paid a lot of attention to the statistical analysis plan to ensure a high degree of precision and transparency. We are very pleased to be recognised with the “Excellence in Trial Statistics” award”.

2019 Consumer Involvement Award Winner
TORPIDO 30/60
Targeted Oxygenation in the Respiratory care of Premature Infants at Delivery: effects on Outcome

Led by: IMPACT 
Coordinated by: NHMRC Clinical Trials Centre, University of Sydney

The TORPIDO 30/60 study wanted to determine which initial concentration of oxygen should be given to preterm babies in the delivery room. Enrolling babies into a study of this nature is complex because it is not always possible or appropriate to gain parents’ consent during a difficult and sometimes highly-stressful situation.

Melinda Cruz – founder of Miracle Babies, acknowledged consumer expert and mother of three babies who were born preterm – was invited to be a member of the Trial Management Committee, eventually gaining a waiver of consent from th ethics committee for TORPIDO 30/60.This meant that more preterm babies could enter the study, widening the study pool and enhancing recruitment rates.

Researchers and clinicians had been asking which level of oxygen was better for preterm babies 30 years, and TORPIDO 30/60 managed to answer that question.

Melinda Cruz has written about her experience in the trial and at the award ceremony on her blog and on the thrive global health site

Thanks to everyone who joined us at The Royal Children’s Hospital, Melbourne, for the Clinical Trials 2019: National Tribute and Award Ceremony. A special thanks also to the members of the three independent judging panels, whose substantial contributions make these awards possible.

ACTA would also like to thank the many supporters of the Clinical Trials National Tribute and Award Ceremony : Our partners; MTPConnect and Medicines Australia and all those supporting the celebrations; Bellberry, CT:IQ, Consumers Health Forum of Australia, Medical Technology Association of Australia, National Health and Medical Research Council, Research Australia and our Venue Partner Royal Children’s Hospital.