Category: <span>Blog</span>
Given ACTA’s and CT:IQs complementary clinical trials sector-boosting focus, and that ACTA is a CT:IQ founding partner, and that CT:IQ held its launch symposium at ACTA’s Trial of the Year awards event, the ACTA Central Team were never going to say “no” to CT:IQ’s newly appointed Program Director, Leanne Weekes, when she asked if she could co-locate at ACTA’s new offices in South Melbourne!
CT:IQ is modelled on the highly successful US FDA-funded Clinical Trials Transformation Initiative (CTTI). It is co-funded by MTPConnect and ACTA is one of the foundation partners along with Bellberry. CT:IQ is working to advance projects spanning the clinical trials sector – commercial and investigator-initiated – that are distinct from ACTA’s work supporting clinical trials networks, coordinating centres, and registries.
Leanne would like to thank the ACTA Central Team for making her feel so welcome!
Stay in touch with CT:IQ by signing-up for its newsletter.
Brisbane 31 October – 2 November 2018
The annual AusBiotech conference has brought together Australian and international biotech leaders and stakeholders for more than three decades, creating a forum to reflect on the sector’s achievements and exchange ideas to further advance the sector’s standing both nationally and globally.
AusBiotech is dedicated to consolidating this growth, and the 2018 conference will once again present issues critical to industry. A number of the Bellberry team are attending this fatastic event and we’d be delighted to chat with you so please come and say hello if you see any of us!
The last HREC meeting of 2018 will be on 19th December 2018, and the first meeting for 2019 will be on 2 January. From 2nd January meetings will be held every Wednesday evening for the remainder of the year.
Bellberry hold eight regular HREC meetings per month and meetings are held every Wednesday evening. All study documentation must be submitted via eProtocol 2 weeks prior to a meeting.
We are able to hold extra meetings if and when required. Please contact Bellberry prior to submitting your documents if you have specific time frames.
Oct 10 – 12, Melbourne
The AHHMS Annual General and Scientific Meeting was this year attended by Trina O’Donnell, Bellberry Operations Manager. The event was titled ‘Collecting and using Big Data – machines, artificial intelligence, epidemiology, precision medicine & health economics’ and Professor Alan Lopez AC presented the keynote address.
Trina reported that the meeting was extremely interesting and thought provoking and covered many of the key issues that are becoming prevalent in the research industry. Further information about the meeting and the session can be found at http://www.aahms.org/events/2018-annual-events/
We look forward to seeing you in Brisbane soon for AusBiotech 2018.
Leading Australian pharmacist and Bellberry board member, Emeritus Professor Lloyd Sansom, has been awarded one of the profession’s highest international honours, the International Pharmaceutical Federation’s (FIP) André Bédat Award. The award is given in recognition of an outstanding contribution to pharmaceutical practice, and is awarded every 2 years.
Lloyd joined Bellberry as a board member in 2012 and has been an invaluable contributor to the Bellberry team. In 2014, he played a pivotal part in the ‘Challenges of Early Crossover in Clinical Trial Design for Oncology’ conference which Bellberry hosted. The conference resulted in the formation of a Scientific Advisory Committee which consisted of an international panel of experts and was chaired by Lloyd. The Advisory Committee developed best practice guidelines for trial design and statistical methods which were published by the International Journal of Technology Assessment in Health Care (Cambridge University Press).
Lloyd is a distinguished educator, researcher and policy advisor and has an illustrious career in health and pharmacy. He has a particular research interest in pharmacokinetics, biopharmaceutics, the quality use of medicines and pharmaceutical policy.
The Bellberry team would like to extend their many congratulations to Lloyd on being awarded this prestigious honour. Further information on the award can be found here.
21-23 August, Sydney
We’re back at ARCS again this year co-exhibiting with our colleagues from PRAXIS Australia. Come and meet the team including CEO Kylie Sproston, Operations Manager Trina O’Donnell, Quality Manager Alison Barr and our two Operations and Support Officers Sally Sims and Tess Penglis.
We’re here to answer any questions you may have about Bellberry or anything related to Human Research Ethics or just come and say hi! We look forward to seeing you all here.
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
In April this year Bellberry recruited two new Operations and Support Officers, Sally Sims and Tess Penglis. The main purpose of this role is to act as a triage service for new studies and to prepare HREC meeting agendas and to support the Committee meeting process. Sally will also talk through any application queries with investigators and assist them in their submission preparation. Sally also runs the montly eProtocol webinar training sessions and works on projects such as the National PICF Project and electronic PICF. Sally was previously a Committee secretary at Bellberry and so brings a wealth of experience and knowledge to this role. Aside from the triage role, Tess is also responsible for coordinating the review and development of policies and SOP’s, which support:- Consensus on best practice
- Consistency in approach to decision making, service and operations
- Improved coordination of services and delivery, and
- Improved compliance with legislative and professional standards
Bellberry are delighted to announce that we have appointed a Quality Manager to the growing Bellberry team. Alison Barr joined us in this role on the 14th May 2018.
Alison has been in the position of Research Governance Officer at Northern Adelaide Local Health Network (22 sites and incorporating the Lyell McEwan) and the Central Adelaide Local Health Network (30 sites) for the last 6 years. Prior to that, Alison spent 6 years as Coordinator in the Heamatology/Oncology Clinical Trials Unit at The Queen Elizabeth Hospital. Alison started her career in health and research administration and has experience of both public and academic research settings. Alison has been involved in national projects such as the NHMRC Good Governance Pilot Project.
The role of a specialist Quality Manager will take responsibility for policy and compliance; the annual site monitoring plan; continuous improvement projects and HREC accreditation (local and international).
We are delighted to announce that Bellberry, ACTA, NHMRC CTC and The George Institute have formed a consortium ‘Clinical Trials: Impact & Quality (CT:IQ)’.
The consortium’s mission is “to develop and implement recommendations that will improve the impact, quality and efficiency of clinical trials, leading to more rapid, lower cost and higher quality evaluation of healthcare interventions in Australia”. CT:IQ will drive performance and impact improvements in Australian Clinical Trials; together we will be Thinking Smarter about Clinical Trials.
CT:IQ is modelled on the highly successful US FDA-funded Clinical Trials Transformation Initiative (CTTI). The pilot project is co-funded by MTPConnect and has commitment from a range of organisations and stakeholders from the Australian Clinical Trials sector.
CT:IQ will be formally launched by Minister Hunt and Minister Cash on Wednesday 16 May at the Royal Melbourne Hospital from 10.30am. This event is also a collaborative effort and will launch CT:IQ, celebrate the ACTA Clinical Trial of the Year Awards and launch the NHMRC consumer engagement campaign. This will be followed by a CT:IQ lunchtime symposium. Registration is free but numbers are strictly limited: https://acta_awards_2018.eventbrite.com.au
For more information, contact Programme Manager Rebecca Trowman at rebeccatrowman@bellberry.com.au
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
Bellberry has two objectives: to protect the welfare of human research participants and to improve the quality, efficiency and effectiveness of research.
In 2017 we worked with a number of partner organisations to imagine a structure to address the question of Continuous Improvement in the Australian Clinical Research sector. Our founding co-partners include the Australian Clinical Trials Alliance (ACTA), the George Institute, and NHMRC Clinical Trials Centre. Bellberry were successful in attracting co-funding from the Pharmaceutical sector growth centre (MTPConnect) to establish a 2-year pilot programme to explore this idea.
The project is due to launch at the start of April and it will be funded for 6 improvement projects. Those specific projects are yet to be finalised, but will be in areas such as Participant Information and Consent, Governance, Big Data and Health Ethics, Novel Trial Structures and Facilitating Multi-Centre Trials.
To assist with the establishment and launch of the initiative, I am delighted to announce we have appointed Rebecca Trowman Day to act as the Programme Manager. Rebecca has a Health Science and Epidemiology background. She has spent the last 10 years in global policy and scientific advisor roles to the National Institute for Clinical Excellence (the UK authority better known as NICE), Health Technology Assessment International (HTAi) and the WA Chief Medical Officer. We welcome Rebecca to the Bellberry team and look forward to the project launch.
Kylie Sproston – Bellberry CEO
Higher Education Conference
28 February – 2 March, Canberra
Universities Australia is the national peak body representing Australia’s 39 comprehensive universities. Delivered by the sector for the sector, the Higher Education conference is the annual signature event on the Australian higher education calendar attracting more than 900 delegates. Participants include Vice-Chancellors, Chancellors, senior university representatives, Government representatives, industry representatives, members of our research community, international education specialists, media and those with an interest in higher education.
The 2018 conference theme – Future Fundamentals – will have speakers exploring the fundamental role of universities in teaching, learning and research as they reinvent themselves in a new political, economic and technological environment. Bellberry CEO Kylie Sproston is looking forward to attending this event.
For further conference information and speaker details please visit the Universities Australia conference website