ACTA, together with Medicines Australia, AusBiotech and Research Australia hosted the Clinical Trials 2016 Breakfast & Award Ceremony on May 20th to mark International Clinical Trials Day and celebrate the announcement of the inaugural ACTA Trial of the Year Award.
We were joined by a number of esteemed guests who took part in the ceremony including the Hon Sussan Ley MP, Minister for Health, Aged Care and Sport who presented the awards, along with Mr Frank McGuire, Victorian Parliamentary Secretary for Medical Research, Professor Anne Kelso AO, CEO of the NHMRC and Mr Wes Cook, Chair of Medicines Australia.
The event held at the AMREP Education Centre in Melbourne was attended by close to 200 leading clinical trialists, researchers, industry leaders and patient representatives. It was widely regarded as a huge success in terms of raising profile for the tremendous value of investigator-driven trials conducted in Australia, and was a clear demonstration of a new era of commitment to strengthening partnerships and building capacity across all levels the Australian clinical trials ecosystem.
This was the inaugural year of the ACTA Awards. We sought nominations for investigator-driven trials for which the primary results were published in 2015, that addressed a critical gap in the evidence, were of an exceptional standard in terms of scientific rigour, and importantly, were expected to translate to a significant change in policy or practice.
Initially, we had intended to announce only one winner, but the nominations received were of such a high standard that our independent judging panel made the recommendation that the Board honour a field of five finalists in addition the winning trial.
On behalf of all members of the ACTA community, we extend our congratulations to the many thousands of people – both researchers and participants – who were involved in the six outstanding trials honoured during the inaugural ACTA Trial of the Year Awards.
The PPROMT trial investigated whether, for women who rupture their membranes before term, immediate delivery or expectant management leads to improved outcomes for babies, in particular, decreased risk of infection.
The trial randomised 1839 women in 65 centres in 11 countries to either immediate delivery or expectant management. There was no difference in the incidence of newborn infections between babies born to women in the two groups. However, babies born to women managed expectantly had a decreased risk of respiratory disease and a decreased need for respiratory support compared with those delivered immediately. They also spent fewer days in a special care baby unit and fewer days in hospital. Women managed expectantly had a lower incidence of delivery by Caesarean Section.
This trial shows that there is no benefit for mothers or babies in immediate delivery following pre-labour preterm rupture of the membranes between 34 weeks and term gestation, in the absence of a clear clinical indication.
Congratulations also to the 5 nominated finalists in this year's award…
This trial tested an innovative, minimally invasive technique called “endovascular clot retrieval”, to remove large clots in the brain after stroke. It found that 71% of patients treated with the new technique regained functional independence within 3 months of their stroke, compared to only 40% who received standard clot-dissolving therapy alone. This means that for every 3 patients treated, an extra patient regained independence. The results of this trial are set to revolutionize the way we treat ischemic stroke caused by a blockage of one of the major cerebral arteries.
The SOFT trial, which recruited 3,066 women in Australia and across the world, showed that treatment with oestrogen suppression can reduce the risk of the most common form of breast cancer in young women recurring by almost half. Further analysis found that when combined with another existing treatment, there were 7 to 8 fewer young women out of every 100 with a breast cancer recurrence within 5 years. This is a globally significant result that will increasingly see this therapy recommended for the very youngest women with hormone-receptor-positive breast cancer.
Over the last 30 years there have been many trials evaluating treatments that aimed to reduce death and improve the quality of life of survivors of Traumatic Brain Injury. None have shown benefit and some have demonstrated harm. The EPO-TBI Trial, conducted in 29 intensive care units in seven countries, is one of the largest ever to be conducted in Traumatic Brain Injury. The trial found that erythropoietin, a readily available pharmacological agent, improved mortality in patients who had suffered a Traumatic Brain Injury. This is the first trial to show a benefit attributable to a pharmacological intervention in this patient population, and represents a major step forward in in reducing the devastating burden of Traumatic Brain Injury.
More than 1,000 nurses and physiotherapists from 56 stroke units across 5 countries came together to test the most effective rehabilitation treatment after stroke. AVERT recruited over 2,000 patients, and is the largest stroke rehabilitation trial ever undertaken globally. The trial showed that, contrary to increasingly popular belief, very early rehabilitation after stroke is not beneficial for patients, and actually leads to fewer patients having excellent long-term recovery. It provided evidence that “more is not always better” and is set to have a major impact on clinical guidelines for stroke rehabilitation across the world.
Heart attack is one of the leading causes of death in Australia. For over one hundred years supplemental oxygen has been administered to patients with suspected heart attack as an initial first aid therapeutic measure by paramedics, doctors and nurses, in the thought that oxygen provides benefit. The AVOID Trial found that supplemental oxygen in patients experiencing heart attack with initial normal oxygen levels, did not relieve their pain or minimise heart damage. Instead supplemental oxygen was found to increase heart injury and dangerous cardiac rhythms both in hospital and at 6 months. The results of the AVOID Trial have led to a dramatic change in practice for all care providers of patients with heart attack both in Australia and around the world.
Our sincere thanks to our event partners for helping to bring together such a successful event.