NHMRC, the Department of Health and the Department of Industry, Innovation and Science are undertaking work to improve the clinical trials environment in Australia.
NHMRC receives funding through the Expediting Clinical Trial Reform in Australia and Simplified and Consistent Health and Medical Research measures to develop a nationally consistent approach to clinical trials, improve efficiency and streamline administration and costs to position Australia as a world leader in clinical research.
NHMRC is working with the Department of Industry, Innovation and Science, Department of Health, States, Territories, clinical trials sites, sponsors and researchers to implement these measures by working to achieve:
- Timely and more efficient research governance authorisation
- Efficient Ethics Approval
- Increased Site Readiness and Transparency
- Better Trained Staff
- Increased Recruitment and Awareness
These initiatives will ultimately lead to Australia becoming more competitive globally and continuing to deliver clinical trials of high quality. You can read more about each of the initiatives by clicking the links below.
Timely and more efficient research governance authorisation
NHMRC is aiming to develop a nationally consistent approach to research governance that includes streamlined and timely site assessment and site authorisation processes.
NHMRC has developed a good practice process (the Good Practice Process) which aims to streamline the site assessment and authorisation phases of clinical trial research governance and reduce start-up times. The Process is now being piloted at 16 sites across Australia.
NHMRC has developed a refined list of standard items associated with clinical trials to further increase the transparency for costing of clinical trials. These items have now been costed by the Independent Hospital pricing Authority.
NHMRC developed reference tables of laws, regulations and mandatory directives that apply to the ethical review and site assessment of human research including clinical trials.
NHMRC has developed a report of indemnity and insurance arrangements for human research which takes place in the public health system, private hospitals, universities and medical research institutes.
Efficient Ethics Approval
NHMRC is aiming to develop a nationally consistent approach that includes streamlined and timely ethics approval.
NHMRC is developing a national application form for research involving humans. A simplified and efficient form will support nationally consistent ethical review and site-assessment for all human research, in particular clinical trials.
Certification of human research ethics committees (HRECs) to conduct ethics reviews of clinical trials including multi-centre trials
NHMRC is reviewing the national certification scheme to determine options for improving the operation of the scheme.
Establishment of National Scientific Committees to provide advice to HRECs on the scientific merit and integrity of research proposals
NHMRC has engaged Bellberry Limited to provide administrative and secretariat services to two independent expert committees which will be established to review research proposals that involve:
- Complex genetic research
- Clinical trials involving medical devices
Increased Readiness and Transparency
NHMRC is aiming to improve the readiness of clinical trials sites and transparency of clinical trial data to be able to measure success and enable Australian sites more competitive internationally.
NHMRC has developed the Clinical Trials Ready initiative which proposes to recognise clinical trial sites, including public and private hospitals, clinical trial units and other trial sites that are ‘ready, willing and able’ to carry out high quality clinical trials in a timely, transparent and efficient manner.
NHMRC has established an advisory committee to provide advice on the implementation of this initiative.
NHMRC is working with the Therapeutic Goods Administration (TGA) to align arrangements for safety monitoring and reporting of clinical trials in Australia with international practices. A consultation on a revised ‘Position Statement’ has just been completed.
NHMRC has provided a statement in support of the principles behind the Alltrials campaign which calls for all clinical trials to be registered and their results reported, to reduce research duplication and legitimise trial results.
Better Trained Staff
NHMRC in conjunction with the Department of Industry, Innovation and Science are developing materials to provide education and support for clinical trials proponents and the clinical trials sector.
NHMRC has published three eLearning modules on the Australian Clinical Trials website to provide an introductory understanding of the nature and importance of clinical trials, their ethics review and governance.
NHMRC is providing support for clinical trials networks to explore issues around clinical trials.
NHMRC are supporting the Department of Industry, Innovation and Science in their development of a VET-accredited course for clinical trials proponents.
NHMRC, in conjunction with the Australian Clinical Trials Alliance (ACTA), is developing competencies for investigators on non-commercially sponsored clinical trials.
Increased Recruitment and Awareness
NHMRC in conjunction with the Department of Industry, Innovation and Science are aiming to provide resources and information about clinical trials and Australian Government initiatives in order to boost recruitment into clinical trials.
NHMRC in conjunction with the Department of Industry, Innovation and Science have developed a website to provide information and resources to consumers, patient and clinicians about Australian Government Clinical Trials initiatives and to facilitate recruitment into clinical trials. The functionality of the website continues to be improved.
NHMRC in conjunction with the Department of Industry, Innovation and Science is working with an advisory group to develop an interactive clinical trials portal.
NHMRC in conjunction with the Department of Industry, Innovation and Science is raising awareness of the website and an understanding of the role and value of clinical trials.