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        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. ...

        Research

        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. ...

        Research

        Clinical Trials in the Brain Tumour Population: Challenges and Strategies for the Future

        This review identifies challenges and barriers to successful development of drugs in neuro-oncology trials at the preclinical, clinical and translational stages that we believe has contributed to poor outcomes for patients over the last 30 years. ...

        Research

        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 ...

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        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. ...

        Research

        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 ...

        Research

        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. ...

        Research

        Longitudinal egg-specific regulatory T- and B-cell development: Insights from primary prevention clinical trials examining the timing of egg introduction

        Egg allergy affects almost 1 in 10 Australian infants. Early egg introduction has been associated with a reduced risk in developing egg allergy; however, the immune mechanisms underlying this protection remain unclear. ...

        Research

        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. ...

        Research

        Standardising and assessing digital images for use in clinical trials: A practical, reproducible method that blinds the assessor to treatment allocation

        We describe the development and evaluation of a protocol for digital image collection by the non-professional photographer in a remote setting research trial ...

        Research

        Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly

        In adult and elderly participants, the full-dose aH5N1c vaccine formulation was well tolerated and met US and European licensure criteria for pandemic vaccines ...

        Research

        The clinical utility of lung clearance index in early cystic fibrosis lung disease is not impacted by the number of multiple-breath washout trials

        This study aimed to determine if relationships between LCI and clinical outcomes of CF lung disease differ when only two acceptable MBW trials are assessed. ...

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