The country’s regulatory environment and organizations such as the MTAA have helped to nurture the increasing interaction between industry and clinical researchers, ushering in more trials that help to improve medical therapy and offer benefits to both patients and the economy. In celebration of International Clinical Trials Day, let’s take a look at the study landscape in Australia and how it has transformed in recent years.
Medical device companies are playing an increasingly important role in Australia when it comes to clinical research. The number of new clinical trials involving medical devices increased greatly by 12.6% annually between 2010 and 2015. In comparison, the growth rate for new pharmaceuticals trials was only 2.7% during the same period. Overall the number of new trials rose by 4.7%.
A number of global medical technology companies are already taking advantage of the favourable conditions that Australia offers for early-phase clinical trials. The regulatory environment is conducive to first-in-man studies and there are dedicated research teams with a strong commitment to data quality. However, more needs to be done for Australia to remain competitive in the international clinical trials landscape. Especially when it comes to early phase studies, time is essential. Recent reforms have targeted limitations such as slow study start-up due to duplication of ethical review of the same study across multiple hospital sites. The MTAA plays an active role in informing public debate as well as government during the reform process via its Clinical Investigations Forum which was formed in 2011.
Fundamentally, clinical trials with medical devices serve patients. They benefit from access to the latest technologies that may not yet be available commercially, advice from and treatment by leading medical practitioners, and, in many cases, closer monitoring of their treatment. Moreover, from a healthcare system perspective, clinical research promotes the use of best evidence in medical decision-making based on health economic value. A vibrant clinical trials infrastructure attracts academic talent with positive flow-on effects for hospitals, communities and even the entire country. Clinical trials have a positive economic impact as well. Not only through the direct investment in clinical studies and infrastructure, but also by rigorously testing innovative technology, thus preparing it for market launch based on solid clinical evidence. For those reasons, the Australian government continues to strongly support clinical research activity.
An example of a recent and potentially guideline-changing trial is CASTLE-AF, which was conducted with BIOTRONIK’s support. The multicentre trial showed a 38% reduction in the composite endpoint of all-cause mortality and hospitalization for worsening heart failure, when catheter ablation was used to treat heart failure patients with atrial fibrillation (AF). All patients in the study had implantable cardioverter-defibrillators or cardiac-resynchronisation defibrillators with BIOTRONIK Home Monitoring technology. The reduction was observed when comparing these patients to patients treated with the pharmacological therapy recommended by current guidelines.
Dr. Johannes Brachman, Coburg Clinic, Germany, who led the trial together with Dr. Nassir Marrouche, CARMA Center, University of Utah, Salt Lake City, US, said: “These findings indicate heart failure patients with coexisting AF should be treated with catheter ablation as a first-line therapy.” The CASTLE-AF study thus contributes to enriching clinical knowledge and further developing therapy options for heart failure patients. Notably, this clinical trial also included two Australian investigators (Dr. Prash Sanders, Royal Adelaide Hospital, Adelaide, SA and Dr. Paul Martin, Royal Brisbane and Women’s Hospital, Brisbane, QLD).
When conducting clinical trials, medtech companies follow strict ethical principles. Each trial needs to be assessed by an independent Human Research Ethics Committee prior to being allowed to commence. The safety of the individual patient in a clinical trial always has priority over the trial itself. Patients choose whether or not to participate and they can withdraw their consent at any time.
On the occasion of International Clinical Trials Day we recognize clinical research and the people that make that research possible. The medical device industry is very fortunate to work with Australia’s brightest and most dedicated clinical research professionals for the benefit of our patients. We congratulate them on their achievements.
ABOUT THE AUTHOR
Falko Thiele, is the Director Clinical and Regulatory Affairs at Biotronik.