Serious Breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree the safety or rights of a research participant or the reliability and robustness of the data generated in the research project.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/serious-breachesSafety and adverse event reports
Maintaining and reporting of adverse events and safety information in research will ensure that RMH complies with the NHMRC's National Statement.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/safety-and-adverse-event-reportsThe Royal Melbourne Hospital is required to monitor all approved research until the completion of the project.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/post-approval-monitoringReporting to the Research Office is a condition of ongoing ethics approval.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/progress-and-final-reportsIs my project quality assurance?
Sometimes it's difficult to determine whether a project is quality assurance or research. Below are a series of questions to help determine whether your project fits the criteria for QA review.
https://www.thermh.org.au/research/office-for-research/ethics/quality-assurance/is-my-project-quality-assuranceFrom time to time, amendments to research projects are required often due to protocol changes, updated investigator brochures, personnel changes on the study, site additions, and more. Researchers and sponsors must notify the HREC of such changes.
https://www.thermh.org.au/research/office-for-research/post-approval-project-management/amendmentsStudy to understand risk of Alzheimer’s disease in middle-aged adults Research study
An Australian-first online study of psychological, lifestyle and genetic factors that increase risk of Alzheimer’s disease.
https://www.thermh.org.au/research/clinical-trials-research-studies/study-to-understand-risk-of-alzheimers-disease-in-middle-aged-adultsThe Department of Anaesthesia and Pain Management has a proud history of conducting quality research.
https://www.thermh.org.au/services/anaesthesia-pain-management/anaesthesia-researchCombination treatment for locally advanced or metastatic ER-positive breast cancer Research study
A phase II, multicentre, randomised study to compare the efficacy of venetoclax plus fulvestrant as a combination treatment for locally advanced or metastatic ER-positive breast cancer.
https://www.thermh.org.au/research/clinical-trials-research-studies/combination-treatment-for-locally-advanced-or-metastatic-er-positive-breast-cancerSailuotong for vascular dementia or Alzheimer’s disease with cerebrovascular disease Research study
A clinical study that is testing a new herbal medicine formula treatment for vascular dementia or Alzheimer’s disease with cerebrovascular disease.
https://www.thermh.org.au/research/clinical-trials-research-studies/sailuotong-for-vascular-dementia-or-alzheimers-disease-with-cerebrovascular-diseaseDeferiprone as a treatment for Alzheimer’s disease Research study
A clinical trial to investigate whether deferiprone delays dementia progression in the early stages of dementia.
https://www.thermh.org.au/research/clinical-trials-research-studies/deferiprone-as-a-treatment-for-alzheimers-diseaseAntipsychotic dose reduction to improve recovery and function in young people with psychosis Research study
The REDUCE study is testing whether reducing the dosage of antipsychotic medication of people recovering from their first episode of psychosis can lead to them having better recovery outcomes.
https://www.thermh.org.au/research/clinical-trials-research-studies/antipsychotic-dose-reduction-to-improve-recovery-and-function-in-young-people-with-psychosisPerampanel to control and prevent seizures in patients with brain tumours Research study
A randomised controlled trial assessing the safety and effectiveness of perampanel, an anti-epileptic drug, in people with brain tumours.
https://www.thermh.org.au/research/clinical-trials-research-studies/perampanel-to-control-and-prevent-seizures-in-patients-with-brain-tumoursEtrolizumab for people with ulcerative colitis who have never used TNF inhibitors Research study
This study aimed to evaluate etrolizumab as a treatment for patients with moderate to severe ulcerative colitis who are naive to TNF inhibitors.
https://www.thermh.org.au/research/clinical-trials-research-studies/etrolizumab-for-people-with-ulcerative-colitis-who-have-never-used-tnf-inhibitorsKPL-716 to reduce pruritus in people with prurigo nodularis Research study
A clinical trial to assess a new drug (KPL-716) for prurigo nodularis (PN).
https://www.thermh.org.au/research/clinical-trials-research-studies/kpl-716-to-reduce-pruritus-in-people-with-prurigo-nodularisPRAX-944 as a potential treatment for essential tremor Research study
A clinical trial evaluating the efficacy, safety, tolerability, and pharmacokinetics of PRAX-944 in adults with essential tremor.
https://www.thermh.org.au/research/clinical-trials-research-studies/prax-944-as-a-potential-treatment-for-essential-tremorDonanemab in early symptomatic Alzheimer’s disease Research study
A study to determine the safety and efficacy of a drug called donanemab in treating or delaying the progression of Alzheimer’s dementia.
https://www.thermh.org.au/research/clinical-trials-research-studies/donanemab-in-early-symptomatic-alzheimers-diseaseBenralizumab for moderate to severe atopic dermatitis Research study
A clinical trial to assess the safety and effectiveness of a new drug called benralizumab for atopic dermatitis (eczema).
https://www.thermh.org.au/research/clinical-trials-research-studies/benralizumab-for-moderate-to-severe-atopic-dermatitisNew drug for moderate to severe hidradenitis suppurativa Research study
A clinical trial to assess the safety and effectiveness of a new drug for hidradenitis suppurativa.
https://www.thermh.org.au/research/clinical-trials-research-studies/new-drug-for-moderate-to-severe-hidradenitis-suppurativaSpesolimab for the treatment of hidradenitis suppurativa Research study
A study to measure how safe and effective spesolimab (the study drug) is in treating participants with moderate to severe hidradenitis suppurativa (HS).
https://www.thermh.org.au/research/clinical-trials-research-studies/spesolimab-for-the-treatment-of-hidradenitis-suppurativa