Clinical Trials Reform Measures

Within the government’s ongoing reforms to support the clinical research sector and broader clinical trials industry, the Department of Industry and Science, Department of Health and the NHMRC will be working on the following activities:

  • develop prices for a list of routine clinical trial items to help promote transparency of standard costs for clinical trials;
  • Incorporate clinical research needs into e-health systems;
  • enable greater participation and engagement in clinical trials through the development of a clinical trials interactive portal;
  • support education and training to improve clinical trial conduct and timeliness of governance approvals; and
  • facilitate the development of a nationally consistent approach to the way clinical trials are overseen and conducted.

Department of Industry and Science Initiatives

The initiatives that the department is responsible for include developing a clinical trials interactive portal and supporting education and training to improve clinical trial conduct and timeliness of governance approvals. An overview on the progress of each initiative to improve the clinical trials environment in Australia is available on the Australian Clinical Trials website.

Education and training

The department has been working closely with the NHMRC to improve the conduct and timeliness of clinical trial governance approvals through education and training.

The department has contracted Swinburne University of Technology to develop and deliver a Vocational Education and Training (VET) accredited course for research governance officers who oversee governance applications and clinical researchers who write applications. This work is based on a training needs analysis undertaken on the department’s behalf by ARCS. To obtain a PDF or hard copy of the training needs analysis undertaken by ARCS, please email the Department at biodiversity@industry.gov.au with your details.

Swinburne University has completed focus group sessions in Melbourne, Sydney, Brisbane, Adelaide and Perth to clarify the needs of research governance officers.

A Steering Group has been established to provide high-level input into the development and content of the training. Further information regarding the Steering Group is available from the department on request.

Swinburne University is currently preparing course document(s) and a course accreditation submission(s) for Australian Skills Quality Authority (ASQA). This work is being informed by a Course Advisory Group comprising a select group of stakeholders who attended the focus groups. The consultant is required to deliver the course before the end of June 2015.

The NHMRC, in consultation with the department, has engaged a consultant to develop learning modules to integrate into the training being developed by the Department. This will support the development of a series of complimentary educational materials for researchers and staff undertaking applications and oversight of clinical trials.

Develop a clinical trials interactive portal

The department is currently undertaking procurement to engage an external service provider to develop a national interactive clinical trials portal. A Portal Working Group has been established to provide specialist input into this process. Membership includes researchers, government, ICT Specialists, jurisdictions, industry and consumer groups.

NHMRC Initiatives

Information about the initiatives that the NHMRC is responsible for and are currently undertaking can be found on their website.

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