Research Austrlaia has responded to the Parliamentary Inquiry into the Approval Processes for New Drugs and Medical Technologies.
Opportunities exist to change our approval processes to benefit patients and better support research and development in Australia. Faster and more effective approval processes mean new medicines and technologies reach patients faster. Improving the environment for clinical trials enables Australian patients to benefit from the latest medicines and technologies developed overseas while also helping Australian health and medical research to flourish in a competitive and lucrative world market. Research Australia’s submission identifies some of these opportunities with the twin objectives of improving Australians’ health and prosperity.
Research Austrlaia’s submission is available here.
The Committee is expected to hold public hearings in early 2021.
Research Australia has responded to the draft National Clinical Trials Governance Framework developed by the Australian Commission on Safety and Quality in Health Care. The subject of an extensive consultation, Research Australia is confident the final Clinical Trials Governance Framework will be an important step forward in improving Australia’s capacity to undertake clinical trials and to improve safety, quality and effectiveness. Research Australia’s submission addresses three areas where further clarity can be provided and improvements made.
Research Australia’s response to the Clinical Trials Governance Framework
In the May 2018 Budget the Government proposed a series of changes to the R&D Tax Incentive which would further reduce the support it provides to private sector R&D activity. While advocacy by Research Australia and others has succeeded in having clinical trial expenditure by small companies exempted form the cuts, several of the other changes remain a concern. Research Australia’s submission to the Senate Inquiry on the new legislation has put the case for why the cuts should be rejected by the Senate.
Research Australia’s submission
On 11 February 2019, the Senate Committee handed down its report. It recommended that ” that the Senate defer consideration of the bill until further examination and analysis of the impact of schedules 1–3 is undertaken. In particular, the committee recommends that:
• the approach to the cap on the refundable portion of the Research and Development (R&D) tax incentive is refined, noting investment decisions already taken; and
• the formula for R&D intensity is refined, noting inherent differences in R&D intensity across industries and impacts on businesses with large operating costs.”
Research Australia welcomes the decision and is pleased the legislation is not proceeding in its current form.
Research Australia envisions a world where Australia unlocks the full potential of its world-leading health and medical research sector to deliver the best possible healthcare and global leadership in health innovation.
Connecting researchers, funders, and consumers to increase investment in health and medical research from all sources.
Engaging Australia in a conversation about the health benefits and economic value of its investment in health and medical research.
Influencing government policies that support effective health and medical research and its routine translation into evidence-based practices and better health outcomes.
To use our unique convening power to position health and medical research as a significant driver of a healthy population and contributor to a healthy economy.
Australian clinical trials received a much-needed boost today with details of the Medical Research Future Fund’s disbursements announced.
The Minister for Health, Greg Hunt announced the detail around the allocation of the funding into clinical trials in Australia that was handed down at the Budget last Tuesday as part of the Medical Research Future Fund (MRFF).
As the Health and Medical Research industry body, we were pleased to hear the importance the Australian Government has placed on clinical trials, collaboration, and translation of research and mid-career medical researchers.
“Clinical trials are a crucial part of changing and saving lives,” said Research Australia CEO, Nadia Levin. “This commitment goes a long way in making a difference to Australians whose lives depend on the outcomes of the best research we can offer”.
The announcement was made at the Royal Prince Alfred Hospital in Sydney at an event to celebrate International Clinical Trials Day.
Continue reading “Funding boost from MRFF for clinical trials”
Research Australia’s submission in response the draft Fifth National Mental Health Plan has highlighted the Plan’s failure to include health and medical research.
Research Australia is concerned that the Fifth Plan is currently a missed opportunity to make better use of Australia’s significant capacity in health and medical research to help deliver the Plan’s vision of healthier Australians, faster and more complete recoveries from mental illness and more responsive and effective services.
The draft Fifth Plan calls for significant reform and innovation in the way we deliver mental health services in Australia, and the health and medical research sector is well placed to help inform, design, implement and evaluate these reforms. Research Australia believes the Fifth Plan provides an opportunity to improve the integration of the mental health system with the health and medical research sector, and to better utilise and direct research towards the Plan’s priorities. Our submission has highlighted some of the many ways in which health and medical research can contribute. Submission for 5th Mental Health Plan
Media Release: Friday 20 May 2016
A clinical trial investigating reducing risk of neonatal infections related to pre-labour ruptured membranes, has been awarded the inaugural Trial of the Year Award 2016 by the Australian Clinical Trials Alliance (ACTA).
Professor Johnathan Morris, chief investigator, this morning accepted the award on behalf of the trial investigators at the Clinical Trials 2016 Breakfast and Award Ceremony this morning from Health Minister Sussan Ley.
Continue reading “Australian take on International Clinical Trials Day”
The Michael J. Fox Foundation‘s Co-Founder Debi Brooks breaks down the pharmaceutical development landscape in an easy to understand analogy and explains how the Foundation plays a critical role in bringing better and improved Parkinson’s disease therapies to patients.
Continue reading “Michael J Fox Foundation explains the pharmaceutical development process”
Prostate Cancer Foundation Australia (PCFA) and the Movember Foundation have today announced funding towards two new clinical trials to address significant research questions that will potentially revolutionise the way prostate cancers are monitored and treated. These clinical trials involve the testing of a new scanning technique and the role of Vitamin D in preventing progression of prostate cancer.
Continue reading “PCFA and the Movember Foundation announce funding for two new prostate cancer trials”
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