Search the site

Patient-advocate-led global coalition adapting fit-for-purpose outcomes measures to assure meaningful inclusion of DEEs in clinical trials

Existing clinical tools that measure non-seizure outcomes lack the range and granularity needed to capture skills in developmental and epileptic encephalopathy (DEE)-affected individuals who also fall in the severe to profound range of intellectual disability. This effectively excludes those with severe impairments from clinical trials, impeding the ability of sponsors to evaluate disease-modifying therapies.

Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19.

Australia needs a prioritised national research strategy for clinical trials in a pandemic: lessons learned from COVID-19

The emergence of the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), sparking a global pandemic, has driven an imperative to quickly design and conduct treatment studies. We strongly propose a national, coordinated approach for randomised controlled trials (RCTs) for coronavirus disease 2019 (COVID-19), future pandemics and inter-pandemic periods in Australia.

Infectious diseases clinician's variation in the management of pediatric Staphylococcus aureus bacteraemia and equipoise for clinical trials

Large variation in antibiotic prescribing amongst clinicians is demonstrated and increased, corresponding with escalating case complexity and persisting MRSA bacteraemia

Rett syndrome: establishing a novel outcome measure for walking activity in an era of clinical trials for rare disorders

This study investigated the capacity of three accelerometer-type devices to measure walking activity in Rett syndrome

2017 Update for the Vaccine Trials Group

Wrap up of the people, projects and updates from 2017 in the Vaccine Trials Group research area, and Dr Peter Richmond.

“If you build it, they will come”: the convergence of funding, research and collaboration in paediatric brain cancer clinical trials

Each year, approximately 1000 children in Australia and New Zealand, aged 0–14 years, are diagnosed with cancer. Despite paediatric cancer accounting for less than 1% of all cancer cases, the impact on their families and communities is profound and disproportionate.

Walking the walk to include pregnant participants in non-obstetric clinical trials: Insights from the SNAP Trial

Despite several calls for greater inclusion of pregnant people in non-obstetric clinical trials, their systematic exclusion remains common practice. Excluding pregnant individuals from clinical trials may result in unintended consequences such as inadequate treatment of medical conditions in pregnancy, inappropriate dosing of medications, and investigational therapies being used off-label outside of the context of a clinical trial, risking adverse events in the absence of demonstrated efficacy.

Rett syndrome: Establishing a novel outcome measure for walking activity in an era of clinical trials for rare disorders

Rett syndrome is a pervasive neurological disorder with impaired gait as one criterion.

A snapshot of consumer engagement in clinical trials in Australia: results of a national survey of clinical trial networks and research organisations

Little is known about the extent, perceptions or experiences of consumers involved in clinical trials across Australia. The purpose of this National study was to better understand the activity and perceptions of clinical trial networks (CTNs), research co-ordinating centres and their consumers, around consumer involvement in clinical trials.