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MA wants national trials office
Posted 8 June 2017
Australia needs a National Office of Clinical Trials as a central point of co-ordination for all jurisdictions to increase the amount of rare cancer clinical research, Medicines Australia has said in its submission to the Senate Select Committee into Funding For Research Into Cancers With Low Survival Rates.
Submission author Elizabeth de Somer, MA's director of policy and advocacy, will join representatives from Roche and AstraZeneca to answer questions from the Senate Select Committee in Canberra later this morning.
The 19-page submission says that while the local industry conducts around 700 clinical trials worth $450 million annually, contributing around $1 billion to the Australian economy "we believe that with the right incentives, Australia can become an even stronger international innovation and investment destination".
"As biotechnology and medical technology are global industries, Australia must compete to retain the R&D activity of local companies, as well as to attract international R&D activity into Australia," it said.
But, it said, the clinical trials environment in Australia was "in need of further reform" and the country would benefit from a national coordination office for clinical trials which would roll out national standards.
With the states and territories making a recent committment to streamlining of the clinical trials system and a $7 million Commonwealth committment to the idea, MA said it was keen to contribute, while not underestimating the size or complexity of the objective and acknowledging "road blocks" to the idea which dated back a decade.
The submission then goes on to recommend:
- more effort to increase Australia's competitiveness and ability to attract more clinical trials on shore
- a flexible approach to reimbursement where, for example, research can be supplemented with real world evidence considering innovative trial designs where it is not feasible to conduct randomised trials, for example, "basket studies" which look at patient groups with a mix of tumour types that have common biomarkers, rather than study each individual tumour
- development of new clinical trial approaches which can increase patient participation
- improved awareness and coordination of patient access to increase clinical trial participation
- streamlining trials approvals process and governance arrangements and implement other actions recommended by MA's earlier reports on the subject
- maintaining the TGA's Clinical Trial notification system "which is critical to maintaining competitiveness" expansion and coordination of biobanks - a collection of biological specimens which help "proof of concept" research for discovery of biomarkers - and genomic registries to guide further research
- having policy that provides predictability to manufacturers and researchers, including the research-based pharmaceutical industry
- creating systems which allow new technologies access in rare and low survival cancer and brain cancer - both as a means of directly improving health outcomes but also to stimulate further investment
- improving system efficiencies and changes to deliver faster access times for patients
- embedding of clinical trials in clinical practice.
There have been previous public hearings in Sydney, Brisbane and Melbourne. Today's hearing will be the fifth and final in the series.
David Rowley
david.rowley@lushmedia.com.au
Posted 8 June 2017
Australia needs a National Office of Clinical Trials as a central point of co-ordination for all jurisdictions to increase the amount of rare cancer clinical research, Medicines Australia has said in its submission to the Senate Select Committee into Funding For Research Into Cancers With Low Survival Rates.
Submission author Elizabeth de Somer, MA's director of policy and advocacy, will join representatives from Roche and AstraZeneca to answer questions from the Senate Select Committee in Canberra later this morning.
The 19-page submission says that while the local industry conducts around 700 clinical trials worth $450 million annually, contributing around $1 billion to the Australian economy "we believe that with the right incentives, Australia can become an even stronger international innovation and investment destination".
"As biotechnology and medical technology are global industries, Australia must compete to retain the R&D activity of local companies, as well as to attract international R&D activity into Australia," it said.
But, it said, the clinical trials environment in Australia was "in need of further reform" and the country would benefit from a national coordination office for clinical trials which would roll out national standards.
With the states and territories making a recent committment to streamlining of the clinical trials system and a $7 million Commonwealth committment to the idea, MA said it was keen to contribute, while not underestimating the size or complexity of the objective and acknowledging "road blocks" to the idea which dated back a decade.
The submission then goes on to recommend:
- more effort to increase Australia's competitiveness and ability to attract more clinical trials on shore
- a flexible approach to reimbursement where, for example, research can be supplemented with real world evidence considering innovative trial designs where it is not feasible to conduct randomised trials, for example, "basket studies" which look at patient groups with a mix of tumour types that have common biomarkers, rather than study each individual tumour
- development of new clinical trial approaches which can increase patient participation
- improved awareness and coordination of patient access to increase clinical trial participation
- streamlining trials approvals process and governance arrangements and implement other actions recommended by MA's earlier reports on the subject
- maintaining the TGA's Clinical Trial notification system "which is critical to maintaining competitiveness" expansion and coordination of biobanks - a collection of biological specimens which help "proof of concept" research for discovery of biomarkers - and genomic registries to guide further research
- having policy that provides predictability to manufacturers and researchers, including the research-based pharmaceutical industry
- creating systems which allow new technologies access in rare and low survival cancer and brain cancer - both as a means of directly improving health outcomes but also to stimulate further investment
- improving system efficiencies and changes to deliver faster access times for patients
- embedding of clinical trials in clinical practice.
There have been previous public hearings in Sydney, Brisbane and Melbourne. Today's hearing will be the fifth and final in the series.
David Rowley
david.rowley@lushmedia.com.au
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