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Post-approval monitoring

The Royal Melbourne Hospital is required to monitor all approved research until the completion of the project.

Progress and final reports

Reporting to the Research Office is a condition of ongoing ethics approval.

Is 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.

Amendments

From 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. 

Study 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.

Our research

The Department of Anaesthesia and Pain Management has a proud history of conducting quality research. 

Combination 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.

Sailuotong 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.

Deferiprone 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.

Antipsychotic 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.

Perampanel 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.

Etrolizumab 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.

KPL-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).

PRAX-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.

Donanemab 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.

Benralizumab 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).

New 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.

Spesolimab 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).

Spesolimab for the treatment of generalised pustular psoriasis Research study

A study to test whether spesolimab prevents flare-ups in patients with generalised pustular psoriasis.

Efgartigimod for the treatment of pemphigus vulgaris or pemphigus foliaceous Research study

A clinical trial to assess how safe and effective the study drug. efgartigimod, is in treating participants with pemphigus who are also receiving oral corticosteroids.