An at-a-glance round-up of the arrangements for clinical trial applications in 10 countries in the region. Australia Australia is unique in that its Human Research Ethics Committees (HRECs) have responsibility for the oversight and ongoing monitoring of trials, including reviews and approvals. The first step is submission of the clinical trial to the HREC for […]
Read More
Approximately a third of clinical trials conducted utilize some elements of Risk Based Monitoring (RBM), with this figure expected to increase. Site monitoring has been identified as one of the largest components of clinical trial expenditure. With the change in the way that site monitoring is performed, the role of the Clinical Research Associate (CRA) […]
Read More
China is Australia’s largest trading partner – worth $8.8 billion in 2014-2015. China and Australia are also growing partners in science and research and this is an important area for growth in bilateral relations. China is and has been Australia’s key focus for science and research collaboration efforts; generating advances in medical research, biodiversity, net […]
Read More
The World Health Organization states that cardiovascular disease (CVD) has been the number one global cause of death; with an estimation of 17.5 million people dying from CVD in 20121, representing 31% of all global deaths. CVD has been and is currently the major cause of death in Australia2 accounting for over 43,600 deaths in […]
Read More
For over 30 years, India has been conducting global clinical trials. With over 500 sites and over a billion people, India was a key destination for clinical trials for its vast treatment naïve clinical population. However, the environment has fluctuated throughout recent years, as The Central Drugs Standard Control Organization (CDSCO), India’s regulatory agency for […]
Read More
Health systems in low and middle income countries continue to face considerable challenges in providing high-quality, affordable and universally accessible care – this is primarily evident in rural areas. As of 2014, approximately 876.1 million people live in rural areas within India with poor access to primary healthcare. This amounts to more than two-thirds of […]
Read More
New research from the International Childhood Cancer Cohort Consortium (I4C) confirms that childhood cancer is linked to birthweight. The incidence of childhood cancer appears to be slowly rising, at a rate of approximately 1% per year in developed countries. Link between birthweight and cancer Risk rose by 26 percent for every kilogram increase in birthweight for […]
Read More
China’s meteoric growth over the past twenty years (or so) has seen it go from strength to strength, particularly in the clinical trials sector. As the clinical trial market of the world’s most populous nation (and second largest economy) continues to mature, so does their regulatory requirements. These regulatory adjustments pose a risk to sponsors […]
Read More
Generally, the unit of randomization in a randomized clinical trial (RCT) is the individual participant (the patient). Occasionally, the unit of randomization can be a cluster, such as hospitals, schools, villages, etc. When randomizing large groups, the concept of cluster randomized trials (CRTs) has become increasingly common. Patient clusters are allocated to the intervention arms […]
Read More
Over the years, technology within medical research has advance enormously, improving its methods of inputting and capturing data. When conducting clinical trials, it is crucial that current data is available throughout the study so that informed decisions can be made from start to finish. Electronic data capture (EDC) systems manage digital data from various channels […]
Read More
