On Monday 20 May ACTA held their National Tribute and Awards ceremony in conjunction with International Clinical Trials Day.

“Clinical trials are vital to ensuring patients receive the best treatments and get the best outcomes. Effective and efficient treatments not only reduce suffering they can also mean less time spent receiving treatment and less money spent by the patient and the health system,” said Prof John Zalcberg, Chair of ACTA.

The winner of the 2019 Trial of the Year award was the ASPREE (ASPirin in Reducing Events in the Elderly) Trial, which looked at the efficacy of people 70 and above taking aspirin daily in preventing age-related illness including heart attack and dementia. The ASPREE study was an international, multicentre clinical trial to determine whether daily low-dose aspiring prolonged good health by preventing or delaying age-related illness such as cardiovascular disease (heart attack and stroke), dementia, depression and certain cancers in the healthy elderly. It is the largest primary prevention aspiring study ever undertaken in healthy people aged at or above 70 years and the first to weigh the benefits versus the risks.

For results of the other awards including the runners up for Trial of the Year and winner of the STiNG Award for Excellence in Trial Statistics please visit the ACTA website.

A Photo Gallery of the event day can be viewed here

As part of the celebrations to commemorate International Clinical Trials Day on 20 May, ACTA are holding a National Tribute and Awards Ceremony. The ceremony will honour the remarkable people who have make ground-breaking clinical trials possible and will include the ACTA Trial of the Year Award, ACTA STInG Excellence in Trial Statsistics Award and the inaugural ACTA Consumer Involvement Award.

The ceremony will be held at The Royal Children’s Hospital, Melbourne, from 8-10am and is free to attend.

Please check out the Award Ceremony flyer for further details of the event.

https://www.australianclinicaltrials.gov.au/international-clinical-trials-day

CT:IQ Projects Update

CT:IQ works collaboratively with the medical research sector to improve the impact, quality and efficiency of clinical trials in Australia, resulting ultimately in the delivery of better health outcomes for the whole community.

The CT:IQ Steering Committee met in December 2018 and selected five projects for CT:IQ to progress in 2019:

1. Consumer Involvement and Engagement
2. E-Information
3. Early Phase Trial Best Practice
4. Clinical Trial Recruitment
5. Biomarker-directed Therapies

CT:IQ welcomes members from across the medical research sector to develop and implement recommendations for investigator-initiated trials and industry-initiated trials.

For more information on CT:IQ and how your organisation could get involved please visit ctiq.com.au or contact us on info@ctiq.com.au.

If you would like to keep up to date, follow CT:IQ on LinkedIn and Twitter

Bellberry is delighted to welcome two new members of staff to the team, Reuben Jacob as Innovation Manager and Jerneen Williams as Early Phase Clinical Trials Manager.

Reuben has a background in science and genetics, and has spent the last decade working in research and in technology commercialisation. He previously worked for a State Government start-up grant program helping early-stage companies to develop and commercialise their intellectual property. At Bellberry, Reuben is responsible for implementing the Innovation Framework – which aims to improve internal processes and systems as well as seeking to solve the pain points of the national clinical trial sector.  In the next few months, Reuben will be reaching out to Bellberry users to explore challenges and potential solutions.  If you would like to be involved, please contact Reuben at reubenjacob@bellberry.com.au

Jerneen has worked in Cancer Clinical trials for 15 years, with a particular focus on early phase studies. She has a BSc in Genetics and a Masters of Medical Science in Clinical Trials (Research).  Jerneen brings significant expertise and knowledge of clinical trials in the public health system to the Bellberry team, along with an understanding of the interactions between Ethics and Governance in the public sector.  In the first instance, Jerneen will focus on assisting the training for new NSW-based users through the NSW Health Early Phase Clinical Trial Framework.  Jerneen can be contacted at jerneenwilliams@bellberry.com.au

Both Reuben and Jerneen look forward to working with you and supporting you with your research programme.

PRAXIS: Essential Project Management Skills for Research and Clinical Trials

I am thrilled to announce the appointment of Sonia Harvey as Project Manager to support the Clinical Trials: Impact & Quality (CT:IQ) initiative.

Sonia has spent the first two decades of her career in a variety of increasingly senior roles at BP including as a Strategy manager, Transformation manager and Compliance & Assurance Manager.  Sonia then moved into a Business Improvement role at INCITEC before working as a consultant to deliver ‘Building Resilience’ programs into multiple organisations.  More recently Sonia has turned her attention to the Health Sector working at SAHMRI as a finance and Strategy Lead for the Wellbeing and Resilience Centre translating the science of psychological health and wellbeing into real world practise within organisations.

Sonia has a wealth of expertise in process improvement, strategy development & implementation, project management and change management within and outside the health sector that will be an incredible asset to CT:IQ.

Leanne Weeks
CT:IQ Programme Director

Our contact number remains the same, 08 83613222, and you can continue to contact us directly by phone or email.

We look forward to continuing to work with you and we invite you to stop by for a tour next time you’re in the neighbourhood.

The first meeting of 2019 will be held on 2 January. From 2 January onwards meetings will be held every Wednesday evening for the remainder of the year.

Bellberry holds eight regular HREC meetings per month. 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.

Wishing you all a happy and safe festive period. We look forward to working you again in 2019!

Another year has flown by and what a busy year its been! On the Committee front, our 8 HREC’s have held 87 Committee meetings and reviewed 478 studies between them.

Within the Bellberry team, we have welcomed six new members of staff: Committee Administrators Emily Dodd, Molly Wundenberg and Kate Fulton, Operations and Project Support Officer Tess Penglis, Quality Manager Alison Barr and CT:IQ Programme Manager Leanne Weekes. Sally Sims (previously a Committee Administrator) also joined Tess as our second Operations and Project Support Officer. Leanne Weekes is heading up our exciting new sector-wide vehicle for the continuous improvement of Clinical Trials, CT:IQ which was officially launched in May. For further information on the initiative please visit https://ctiq.com

The Bellberry office will be closed for the Christmas break from 24 December to 1 January 2019, however eProtocol will be available 24/7 over the Christmas period.

We would like to thank you all for your support over the past year and wish you all a very Merry Christmas and New Year. We look forward to working with you all again in 2019!

Submission deadline for last meeting of 2018!

If you would like your study to be reviewed before the Christmas break, please ensure you submit all study documentation via eProtocol by Wed 5 December.

Alternatively, our first meeting of 2019 will be held on 2 January. The submission deadline date for this meeting is December 12th.

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.

The last HREC meeting of 2018 will be on 19^th 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.

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.