Which clinical trials need a Clinical Endpoint Adjudication Committee?

Increasingly, regulatory authorities are placing significant focus on clinical trial processes that ensure consistent, standardized, objective and unbiased reporting of safety and efficacy results; given that the definitions for many endpoint events include subjective components, and investigator-to-investigator subjective assessments may differ. Moreover, an increasing number of trials are now conducted in multiple geographies, and clinical […]

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Why digital health is beneficial to clinical trials

In the world of healthcare, time is always of the essence. Researchers are continuously looking for new solutions to help improve patients’ well-being and ultimately save lives. The discovery process of new treatments takes an enormous amount of time and resources in order to generate good evidence to prove that they are safe and that […]

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Thrombolysis will continue to be the mainstay for acute stroke treatment

Thrombolysis will continue to be the mainstay for acute stroke treatment, despite the recent revolution in neurointerventional clot retrieval. However, as there are ongoing limitations of thrombolysis of bleeding risk and reduced efficacy in large clots – what possible therapeutic advancements can complement or act as an adjuvant to thrombolysis? Neurointervention – effective, but limited […]

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Regulatory timelines in the Asia-Pacific

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 […]

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The Changing Role of the CRA in an RBM World

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) […]

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China-Australia Free Trade Agreement – The Healthcare Opportunity

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 […]

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Preventing cardiovascular disease through a simple text message

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 […]

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Steadying confidence for clinical trials in India

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 […]

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SMARTHealth – A study on e-health in rural communities

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 […]

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