Clinical trials are essential to the development of new medical treatments, standards and interventions to help people live longer or have less pain or disability, and ultimately reduce the burden on health systems. Government funding of medical research is vital to the discovery of breakthrough treatments for disease and illness; it also leads to job creation and growth of local industry.
But funding isn’t the only role the government has to play – Australian clinical trials are renowned for high-quality patient care, thanks to a rigorous regulatory environment overseen by Commonwealth and state and territory governments, as well as trial sponsors, the Human Research Ethics Committee (HRECs), approving authorities and investigators. The Commonwealth Government’s Therapeutic Goods Administration (TGA) is also a key player, regulating access to ‘unapproved’ therapeutic goods in clinical trials.
Australia’s regulatory framework is well-regarded by researchers locally and internationally, as it comes with several benefits including an efficient approvals process, tax incentives, world-class facilities and talent, and research data that is considered high-quality, reliable, and accurate.
Clinical trials are just one part of the medical research process and long-term investment is usually required to complete the entire development process, including discovery right through to bringing a new treatment to the patient. For this reason, funding may be needed from several sources including industry, educational institutions, and pharmaceutical companies.
Government Funding Sources Available
The National Health and Medical Research Council (NHMRC) is the Australian Government’s primary health and medical research funding agency and follows a ‘peer review’ process to ensure impartiality in funding allocation. In particular, the Clinical Trials and Cohort Studies (CTCS) Grant scheme provides funding for trials or studies that are expected to improve health and wellbeing, healthcare practices or policy.
An example of an NHMRC-funded trial is HomeBase which supported new approaches to treating Chronic Obstructive Pulmonary Disease (COPD) specifically, ‘at home’ virtual care. This has become a critically important mode of care delivery, particularly since the COVID-19 pandemic.
NHMRC also offers funding to support Australian researchers in collaborating on international research projects, important given Australia’s population size. Participation in international projects can help ensure clinical trials are of an appropriate sample size.
Government funding is also available via the Medical Research Future Fund (MRFF) which was established in 2015. Every year, the Australian Government uses net interest from the fund to pay for various research initiatives.
Funding is offered through a range of initiatives, including the MRFF’s Clinical Trials Activity, set up to address rare cancers, rare diseases, and unmet needs, and to increase local and international medical research activity in Australia.
Government funding of medical research is also facilitated through the Research and Development Tax Incentive (R&DTI). Under this scheme, sponsors can apply for a tax offset for eligible R&D activities. For example, biotechnology company Admedus Immunotherapies secured $3.37 million over three years to run clinical trials for the development of a vaccine to treat cancerous and pre-cancerous conditions caused by Human Papilloma Virus (HPV).
Types Of Government Grants
Government grants take different forms, from research to infrastructure and innovation. The MRFF provides research grants based on national priorities, and its current grant recipients include government agencies, research institutes, and universities. For example, Monash University has secured funding to research whether stem cells can be used in the treatment of people with drug-resistant epilepsy.
Infrastructure grants are available to help upgrade existing medical facilities, including expanding training facilities or creating ‘super clinics’ for General Practitioners, nurses, and allied health professionals. The Medical Research Support Program is a major source of infrastructure funding for eligible independent medical research institutes across NSW.
As the name suggests, innovation grants provide funding for innovative or creative research and are often targeted at ‘early career’ researchers. Innovation grants generally do not provide funding where a clinical trial is the main objective, given there are already grants for this specific need. The NHMRC supports innovative research projects through the Ideas Grant scheme.
Getting Your Trial Funded
The TGA’s Clinical Trial Handbook notes that before a clinical trial begins, all parties should be satisfied that the rights, safety, and well-being of trial participants will be protected, and the data generated will be reliable and robust.
Generally, for a trial to be funded, the following areas should be addressed:
- The intended health outcomes.
- Whether the initial basic research indicates a successful outcome is possible and the results of that research have been peer-reviewed and published in a respected scientific or medical journal.
- Potential health risks to trial participants and how they will be minimized or managed. The risks should have been assessed by the Ethics Committee of the sponsoring medical facility.
- Scope of the trial, for example, Phase 1, 2, 3 or 4.
- The data analysis methods that will be used to evaluate the result.
- The previous and current experience and expertise of the facility where the trial will be conducted.
Overall, Australia offers a robust environment for conducting clinical trials, enabled by a range of funding sources. If you want to learn more about how you can successfully navigate clinical research in Australia with a team of professionals who are committed to safe and ethical studies, get in touch with us today.
