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Designing and operationalising trials

The George Institute has a highly skilled team which works to conceptualise, develop, and deliver innovative and impactful clinical trials, characterised by the following features: Reducing trial ‘waste’ Ensuring that clinical trials are efficient is crucial to minimising research ‘waste’, which most commonly results from the costs associated with poorly conceived research questions, inappropriate study design, failure to adequately report on all areas being analysed, and inefficient operational conduct. Trial efficiency can be improved via two key mechanisms- by design and by conduct. Trial design involves the development and application of innovative statistical methods including adaptive and pragmatic designs. The first involves adapting some elements of the design as the trial progresses (rather than waiting for the trial to end). A pragmatic trial evaluates a health intervention in a setting as close as possible to real-world conditions. Adaptive designs help to gener

What are clinical and community trials

What are clinical trials? Clinical trials are research studies with humans, designed to test new treatments to find better ways to prevent, detect or treat disease1. Clinical trials are also sometimes referred to as interventional trials. The sorts of treatments being investigated include medicines or drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, and other items.2 Clinical trials rely on having members of the general public agree to take part. What happens in a clinical trial? In a clinical trial, participants meet with researchers who go through what the clinical trial will involve. All participants must be advised about the objectives of the research, what is expected of them, as well as any risks that may be experienced during and after the trial. Trials must follow a carefully controlled protocol, which is a plan that describes what researchers will do in the stu

Innovative clinical trials

Researchers at The George Institute for Global Health, UK, led by Executive Director Professor Otavio Berwanger, are spearheading a programme of work to transform that way we deliver large-scale clinical trials. This programme is borne out of a recognition of the limitations of the ‘traditional’ clinical trial model – and the health gains (social, environmental and economic) – to be had in investigating pragmatic, innovative and efficient approaches. In both the so-called ‘traditional’ and innovative trial models, the gold standard of randomisation controls for both known and unknown confounding factors that could influence trials outcomes, and represents the optimal method to work out whether a healthcare intervention reduces the risk of patient-important outcomes and so inform clinical practice. Where the two models differ is that the traditional approach requires participants be screened and recruited in a trial site by a team of investigators, and so demands both a

COVID-19 Preparedness Checklist For Rural Primary Health Care & Community Settings

Policy & Practice Report

EnSWIn: Environmental Support for Walking In India (pilot)

This study includes primary and secondary data collection, and uses surveys, photographs, and in-depth exploration of the perspectives of a subset of selected respondents. The findings will shed light on the association between built environment and physical activity in a wide range of adults living in different zones of the 2 study sites.

Perspectives, practices, and environmental footprints related to menstrual hygiene among girls and women in India – a pilot study [PEnMen-pilot]

Background: Menstrual hygiene management (MHM) is a generally under-researched area in India, although vital to the promotion of women’s health. Although there has been, particularly in recent years, some attention given to the provision of affordable menstrual absorbents, practices of treatment and disposal of the used absorbents have not received adequate attention from policymakers, and implementers, and pose ever-growing challenges to environmental sustainability and the personal health, well-being, and functioning of girls and women, with implications for the accomplishment of several SDGs. Aim: (i) to understand community perspectives, preferences and behavioural control related to treatment and disposal of menstrual absorbents, and the associations that women and girls make between menstrual hygiene practices and personal and environmental health; and (ii) to estimate the environmental footprints of the menstrual hygiene management practices that come up in the data-collection Research M

COVID-19 Preparedness Checklists for Urban Primary Health Care & Community settings

Policy & Practice Report

Self-management and action plans for preventing acute exacerbations due to COPD: evidence summary

Policy & Practice Report

Beta-lactam antibiotics infusion group study - BLING III

Background: Beta-lactam antibiotics are commonly used to treat life-threatening infections in critically ill patients. As a class of antibiotics, beta-lactams are known as time-dependent antibiotics because they have their greatest effect when the antibiotic concentration in the blood remains above a critical level (dependent on the organism) for the duration of the course. Continuous infusion of beta-lactams has been shown to more consistently achieve these time-dependent pharmacodynamic endpoints than the standard practice of bolus dosing. However, the relatively small randomised controlled trials to date have not reported improved clinical outcomes, such as resolution of infection or lower mortality, with the use of continuous infusion A prospective, multicentre, double-blind, double-dummy, phase II RCT (BLING II) was conducted in 25 ICUs in Australia, New Zealand and Hong Kong. While there was no significant difference in the primary endpoint, it found an absolute difference in hospital mortality

Sweet Transition: Priorities for collaborating to transform the food system in Australia

Policy & Practice Report

Primary prevention of asthma and chronic obstructive pulmonary disease at the primary healthcare level: rapid policy brief

Policy & Practice Report

The Potential Impact of Salt Reduction in Australia

Policy & Practice Report