AusBiotech is inviting members to express interest in joining a new advisory group to provide guidance and advice on policy impacting clinical trials (CTs).
During 2016, more than 80 AusBiotech members attended invitation-only roundtables to discuss issues related to CTs, in a series of consultation meetings, held across Australia. Roundtable consultations were held in Queensland, Adelaide, Melbourne and Sydney, supported by Novotech, AbbVie, Deloitte and KPMG.
The new CT Advisory Group will build on the discussion held during the roundtables and assist in the development of policy positions with advice, to work toward a more effective environment for CTs.
CTs are worth around $1 billion to the Australian economy annually, including around $650 million in foreign investment, with Australia attracting trials from around the world.
Industry is at the forefront of conducting CTs as the largest investor in clinical research in Australia; estimated to spend more than 10 times as much as the Federal Government’s research funding body, the National Health and Medical Research Council.
CTs are a critical component in the development process of bringing new therapies, devices and diagnostics to patients and the most recent AusBiotech survey of the industry showed that 55 per cent of respondent companies conducted CTs in the previous year.
The purpose of the roundtable was exploring policy issues related to trials as many members continue to indicate concerns and the gatherings were met with enthusiasm and interest. Key issues raised included:
- Start-up times;
- Key elements of decision making around where to place trials;
- Recruitment in Australia;
- Regulation of CTs in new areas of technology;
- TGA support/advice for SMEs;
- Funding for trials and the importance of the R&D Tax Incentive;
- Requirements for diagnostics trials;
- Synchronisation of multi-centre CTs; and
- Issues in developing orphan therapeutics.
The first meeting of the CT Advisory Group is expected to be held in February. For further information and to indicate interest in joining the CT Advisory Group, please contact Deputy CEO, Lorraine Chiroiu (lchiroiu@ausbiotech.org / 03 9828 1400).