George Clinical – Page 11 – George Clinical

Which clinical trials need Endpoint Adjudication

Which clinical trials need a Clinical Endpoint Adjudication Committee?

By George Clinical
Research

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 […]

January 8th, 2017

Why digital health is beneficial to clinical trials

By George Clinical
Research

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 […]

January 6th, 2017

Utilizing clinical research organization for late phase I studies

Utilizing Clinical Research Organizations for late Phase I studies

By George Clinical
Research

A key step in developing a new drug is the transition from the laboratory to the human subject in a Phase I clinical trial, where the new compound is given to humans for the first time. A Phase I trial is the gateway between scientific research and clinical medicine. Generally, in-human Phase I studies are […]

January 4th, 2017

Thrombolysis will continue to be the mainstay for stroke treatment

Thrombolysis will continue to be the mainstay for acute stroke treatment

By George Clinical
Research

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 […]

January 2nd, 2017

Regulatory timelines in the Asia-Pacific

By George Clinical
Research

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 […]

December 30th, 2016

The Changing Role of the CRA in an RBM World

By George Clinical
Research

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) […]

December 28th, 2016

China-Australia Free Trade Agreement – The Healthcare Opportunity

By George Clinical
Research

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 […]

December 26th, 2016

Preventing cardiovascular disease through a simple text message

By George Clinical
Research

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 […]

December 23rd, 2016

Steadying confidence for clinical trials in India

By George Clinical
Research

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 […]

December 21st, 2016

SMARTHealth – A study on e-health in rural communities

By George Clinical
Research

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 […]

December 19th, 2016