Clinical trials are conducted in human volunteers to test that new drugs, devices and therapies (‘interventions’) are safe and effective. A new compound may kill tumour cells in mice, but will it work effectively in people, and how big a dose is required? Can it be delivered as a tablet, or is an injection more effective? These are some of the questions that can only be answered with a clinical trial. For people with hard to treat diseases, participation in a clinical trial for a new drug may offer the only opportunity for a cure.
Clinical trials also provide the opportunity to compare the effectiveness of existing treatments or practices, to determine if they actually work, and which is best.
Clinical trials in Australia are subject to strict rules to protect participants and ensure the integrity of the trial process, so that the results can be relied on when deciding whether to allow a new intervention to be offered to patients in Australia, or whether existing practices should be changed.
More information about clinical trials is available on the Research Australia website, or at www.clinicaltrials.gov.au
The NHMRC has consulted on a Good Practice Process for Clinical Trials with the aim of improving clinical trials governance. Research Australia has made a submission welcoming the initiative and acknowledging that it is one of a number of actions being undertaken to improve, standardise and streamline clinical trial processes, including by COAG’s Standing Committee on Health. Research Australia’s submission highlights the benefits of moving to a national, standardised approach to clinical trials, points to some possible improvements to the process and identifies some state- specific regulatory barriers.
Clinical Trial Research Governance
The South Australian Government issued a discussion paper seeking on the suitability of Social Impact Bonds to fund innovative new programs. Research Australia’s submission proposes the use of Social Impact Bonds to address the well recognised problem of translating research outcomes and discoveries into practice in the health system. Specifically, Research Australia believes that Social Impact Bonds could be an effective mechanism for funding and evaluating pilot projects and clinical trials designed to implement and evaluate new evidence based practices and interventions. The benefits of implementing successful new interventions are improved patient care and efficiency gains in the South Australian health care system.
Social Impact Bonds South Australia