Category: <span>Industry News</span>
Last month CanTeen became the latest organisation to join the CT:IQ Steering Committee. Bringing an important perspective, CanTeen help young people cope with cancer in their family and provide specialist youth-specific treatment teams and have young people affected by cancer guiding the organisation at every level. CanTeen are one of the many organisations that have demonstrated their support of the CT:IQ initiative by joining the Steering Committee. Others include the Icon Cancer Foundation, Novartis, SPHERE, Cancer Trials Australia, Neuroscience Trials Australia, Linear and CMAX.
In June Medicines Australia also announced that they were joining the executive committee. For further information about the CT:IQ initiative please visit their website at https://ctiq.com.au or if you are interested in joining please visit https://ctiq.com.au/contact-us
If you are a current ACTA (Australian Clinical Trials Alliance) member and you know of a network or group that published the primary results of a high-impact trial in 2017 (either electronically or in print), ACTA encourage you to read the award guidelines and consider nominating the trial for the 2018 Trial of the Year Award.
A reminder that trials nominated in 2018 will also be considered for the ACTA STInG Excellence in Trial Statistics Award 2018.
The awards will be announced in Melbourne on the morning of Wednesday 16th May.
The Trial of the Year Award 2018 Guidelines and Nomination Form can be downloaded from the ACTA website here.
Nominations will be accepted until 5pm, Wednesday 18 April 2018.
Please contact ACTA for further information.
The TGA have recently released the revised Australian clinical trial handbook and it is now available on their website. The Handbook has been updated to reflect current practice. The TGA have also consolidated information from the following previous clinical trials guidance documents:- Access to unapproved therapeutic goods – Clinical trials in Australia
- Australian Clinical Trial Handbook
- Human Research Ethics Committees and the therapeutic goods legislation
We are pleased to announce that NHMRC funding for the National Scientific Committee’s (NSC) pilot project has been extended for a further 12 months.
The NSC’s were launched by the NHMRC in January and provide scientific review for the areas of Complex Genetic Research and Medical Devices. Based on the queries received from the initial pilot period, the review areas have also now been extended to include early phase clinical trials. The Committee’s, hosted by Bellberry, provide advice to HRECs, sponsors and researchers on the scientific merit and integrity of a research protocol.
Three applications have been submitted so far with two of these being reviewed at the inaugural NSC meeting held in June. The NHMRC funding extension will enable the project to continue until June 2018.
If you are interested in submitting a proposal to the NSC or for further information about the Committee’s please visit the NSC website or contact the NSC administrator at nsc@bellberry.com.au
Bellberry are thrilled to launch their partnership with The South Australian Health and Medical Institute (SAHMRI) to establish the Bellberry Molecular Imaging Program; a project that will allow the development of a series of diagnostic agents that will enhance SAHMRI’s ability to deliver improved healthcare, clinical trial capacity and translational health outcomes.
This partnership will deliver world-class research, which will both attract the pharmaceutical industry and retain the brightest scientists in the field to South Australia.
The importance of Imaging
Imaging has become a powerful tool in SAHMRI’s research strategy. In particular, molecular imaging provides the ability to use radiopharmaceuticals to study the functionality and progression of disease.
This program offers the opportunity to study how diseases may behave differently in individual patients, with important implications in the development of a more personalised approach to disease diagnosis and treatment.
Thanks to this support from Bellberry, South Australians will be able to benefit even more from the state’s only cyclotron that is housed at SAHMRI.
Over the next seven years, tracers will be developed for diseases ranging from bone, breast and prostate cancers, through to Parkinson’s Disease, Epilepsy, and Alzheimer’s Disease.
Molecular imaging permits the ability to locate disease, reveal its individual components, and could potentially also help examine disease mechanisms, and markedly advance the personalisation of disease prevention and treatment.
A partnership to benefit all South Australians
SAHMRI’s Executive Director, Professor Steve Wesselingh, said that the benefits of this partnership with Bellberry are countless.
“The Bellberry Molecular Imaging Program will advance South Australia as a leader in translational biomedical research by improving health outcomes, growing the knowledge economy and attracting industry partners as Australia looks to rapidly expand the health and medical sector as a major economic priority,” he said.
“We are incredibly grateful to Bellberry for their support and belief in this program.”
Director of SAHMRI’s cyclotron, Prab Takhar, said that this funding allows the cyclotron to develop a platform that will transform clinical care and research in the state in a very short time frame.
“This funding has already enabled us to begin developing agents, which are being used clinically in the state.”
Bellberry Limited’s Chief Executive, Ms Kylie Sproston, said “Bellberry exists to support research and ethics, to protect the welfare of research participants and to improve research. We are delighted to support the availability of these capabilities at SAHMRI, for the use of researchers throughout the State”.
This month we were delighted to welcome back Lauren Griswood (nee Guscott) to the Bellberry team. Lauren previously worked at Bellberry as a Committee secretary but has returned in a new role as administrator for the new NHMRC funded National Scientific Committee’s (NSC) that are being hosted by Bellberry.
The NSC’s were launched by the NHMRC in January and provide scientific review for the areas of Complex Genetic Research and Medical Devices. The Committee’s will provide advice to HRECs, sponsors and researchers on the scientific merit and integrity of a research protocol. Lauren was involved in the setup of the Committee’s and will be administrating then going forward.
Please feel free to contact Lauren for further information about the Committee’s and how to submit a proposal at nsc@bellberry.com.au
Further information can also be found at the NSC website
In October 2014 Bellberry hosted the Crossover conference, an international expert scientific meeting that addressed the challenges of early treatment switching in clinical trial design for oncology. A further scientific meeting in 2015 allowed for the development and launch of best practice guidelines for trial design and statistical methods from an international expert panel.
Bellberry are pleased to announce the publication of two papers arising from the scientific meetings, which have now been accepted by the International Journal of Technology Assessment in Health Care (Cambridge University Press.)
The first is entitled ‘Treatment Switching: Statistical and Decision Making Challenges and Approaches’ (N. Latimer, C.Henshall, U. Siebert and H. Bell)
The second is entitled ‘Treatment Switching in Cancer Trials: Issues and Proposals’ (N. Latimer, C. Henshall, L.Sansom and R. Ward)
From 1 July 2015 the Clinical Trials Notification (CTN) Scheme transitioned from a paper based form to an online format. The paper-based notification form is now no longer available as there are some differences in the required information for the online form.
As a reminder any paper based forms the TGA receive after 1st July 2015 will need to be submitted online via the TGA Business Services website
Bellberry have prepared a Guidance document for Bellberry applications. This is available on the Investigators pages under Policies, SOPs, Guidance. Please contact us if you have any queries.
Bellberry are delighted to announce the launch of the PRAXIS Australia website at http://www.praxisaustralia.com.au/
PRAXIS Australia Ltd promotes the understanding and practice of ethical human research in Australia and internationally, to enhance the welfare of research participants and the quality and effectiveness of research.
Over the next few weeks PRAXIS will expand their online services with resources and a communication forum that promotes the exchange of ideas and facilitates discussion around matters of interest to the research ethics and research communities.
Please visit the PRAXIS site to register for courses, subscribe for updates or simply ask a question about PRAXIS services or other tailored training needs.
Bellberry is a Member Organisation of PRAXIS and fully support this initiative.
e: info@praxisaustralia.com.au
With the support of Bellberry funding, SAHMRI has now commenced the first Bellberry Research Fellowship. Dr Michael Musker, the recipient of the Fellowship, works within SAHMRI’s Mind and Brain theme and is examining gene-environment interactions in obesity, depression and their interface.
Bellberry’s donation for this Fellowship was recognised by the SAHMRI in their latest Newsletter.
‘International Conference grapples with ethics’
Bellberry was in the news again recently after the hugely successful Crossover Conference, hosted by Bellberry in October, ABC News wrote a full article on the event. To listen to ‘The World Today – Patients demand more rights in clinical cancer trials 24/10/2014’ article and hear E/Prof Lloyd Sanson and Chris Henshaw speaking about the Congress please click hereGrowing demand for review services indicates healthy Clinical Research environment
This month Bellberry featured in Life Sciences Queensland’s quarterly newsletter. Check out page 6!Bellberry is delighted to announce that its 5th Human Research Ethics Committee has been registered, ahead of an inaugural meeting in July 2014.
In the preparation phase ahead of the formal launch, the Bellberry team has been busy behind the scenes with the recruitment and selection process. All new HREC members are being supported with a training and development programme ahead of launch. This programme includes:
• induction training in Bellberry processes and policies,
• technical support in the virtual ethics collaboration environment.
• observation activities gaining experience in ethics review in existing committees.
• mentor support.
The 5th committee adds further capacity to the Bellberry ethics review process. With Bellberry holding at least one HREC meeting every week, we are able to provide researchers with a 2-week lead time from submission to review
James Cook University researchers search to see if bitter and ugly cucumber may be cancer cure
Bellberry HREC has featured in an article in the Cairns Post regarding the supported research they have provided to James Cook University researchers.