Category: <span>Blog</span>
Join experts from Austrade, Baker McKenzie, Bellberry and IQVIA in a discussion on conducting clinical trials in Australia. This one hour webinar will explore:
- the benefits of conducting clinical trials in Australia for US companies
- the steps in the clinical trial process
- due diligence issues to consider
- how to apply for an Australian R&D tax incentive.
There will also be an opportunity for questions. Bellberry CEO Kylie Sproston will be part of this discussion.
Click here to register!
Congratulations to Bellberry CEO Kylie Sproston on being a winner of the 2021 ARCS MTP Sector Awards. Kylie was announced as the Innovation award winner at the ARCS 2021 awards dinner in Sydney last night. Other recipients were NSW Health, Pathology, as innovation award winner and Co-Directors Nick Ward and Johanna Hann from PharmatoMarket winners of the Leadership award.
Kylie was honoured to receive the award and said “In accepting this award, I’d like to acknowledge my incredible team at Bellberry: staff, HREC member community and our supportive Board. We’re forever asking ourselves how we can better deliver on our objectives: to improve the welfare of human research participants and improve the quality, efficiency and effectiveness of research.
Delivering on those objectives is only possible with the teamwork that happens every day in the clinical trials environment: research site staff, investigators, CROs and Sponsors coming together to deliver health and medical research. The last word as always should go to the communities in which we operate and our participants, without whom none of this is possible”
Join us in Sydney next week for the ARCS 2021 annual conference.
The conference is renowned for being the must-attend conference for the pharmaceutical and medical technology industries. It brings together decision-makers as well as a broad cross-section of people working in industry, government and the university sectors. The conference will provide a unique opportunity for those attending to participate in plenary sessions, workshops and round tables. Sessions will be of relevance to professionals involved in regulatory affairs, clinical research, pharmacovigilance, medical affairs, health economics and quality/Gmp and the wider healthcare community.
It’s a great networking opportunity with delegates coming from a wide cross-section of the industry including senior executives to recent graduates. In 2019, over 2200 day delegates visited the conference.
Please feel free to drop by the Bellberry exhibit, we look forward to seeing you!
Breakthroughs in prostate cancer screening and a ‘watch and wait’ treatment for collapsed lung share the Australian Clinical Trials Alliance 2021 Trial of the Year Award The Australian Clinical Trials Alliance (ACTA) is pleased to announce dual winners of their preeminent 2021 ACTA Trial of the Year Award. This event celebrates the vital role trials have in advancing clinical practice and saving or improving patients’ lives every year. The dual winners of the 2021 Trial of the Year Award are:- ProPSMA Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (ProPSMA): a prospective, randomised, multicentre study.
- Pneumothorax study A randomised controlled trial of conservative versus interventional treatment for spontaneous pneumothorax.
The Bellberry team celebrated International Clinical Trials day with a morning tea hosted by our EPCT team.
Jerneen Williams (HREC EPCT Manager) provided information on the background to International Clinical Trials Day, gave an update on the EPCT team and showed two video clips showcasing clinical trials from two different perspectives – one from a clinical research organisation (https://www.rarecancers.org.au/page/82/clinical-trials) and one from a trial participant (https://vimeo.com/272688909).
Photos from today’s event:
Bellberry also published its May Newsletter today with includes articles about International Clinical Trials day, ACTA’s National Tribute and Awards ceremony being held tonight, our Clinical Trial Activity Report for 2020 and much more! Please take some time out to read.
Bellberry is the largest independent reviewer of CTN trials in Australia. This year on Clinical Trials Day, we’re pleased to share a summary report which describes research activity overseen by Bellberry HRECs through 2020.
This activity report represents a significant proportion of the Australia wide CTN trial activity across the development lifecycle. It demonstrates capability and capacity in a broad range of research areas. The report also captures the originating funding location for inward investment in Sponsored clinical trials, again demonstrating Australia’s active participation in the global development process.
Bellberry Clinical Trial Activity Report 2020 (170 downloads )
AusMedtech 2021: Reimagine and reconnect provides a week of virtual half-day sessions that represent Australia’s medtech industry; celebrate the successes and impacts the industry has made, and engage on the reimagined future of medtech.
Kylie Sproston, Bellberry CEO, will be part of a panel discussion being held on Tues 18 May titled ‘Lessons learnt: Clinical trials, ethics and governance, regulatory approvals and the new normal’
AusMedtech week will be delivered online
The AAHRPP annual conference will take place from May 18 to May 20. Join Kylie Sproston, Bellberry CEO, and Dr. Amal Al Omari, Speakers Chief Scientific Officer King, Hussein Cancer Center at their session on May 20 entitled ‘International Research – Collaboration During Crisis’
Bellberry has updated the site-specific clauses document (BA F1.1.12) to include examples and a pre-submission checklist.
Please note the following:
- As a minimum, the HREC requires sites to outline their changes to the Master Main PICF.
- A review of the clause documents has found that most sites only make changes to the Master Main PICF. Therefore, to improve efficiency, the HREC will no longer return the site-specific clauses template if the site has overlooked listing supplementary PICFs (e.g. pregnant partner, optional biomarker PICFs).
- As per the terms and conditions of HREC approval, the site must submit an amendment if any ethical changes to content are required.
Please see the updated form here.
Join ACTA in honouring the remarkable Australians who advance our health system by designing, conducting, or participating in ground-breaking clinical trials and promote the importance of clinical trials and the expertise and complexity of the work involved.
This collaborative event will recognise the achievements of the research sector, with awards for the ACTA Trial of the Year, ACTA STInG Excellence in Trial Statistics, and the ACTA Consumer Involvement. The Award Ceremony will be preceded by the launch of the ‘Clinical Trials in Australia’ report and a panel session hosted by MTPConnect.
A networking reception will follow the Award Ceremony with drinks and canapes and the much-needed opportunity to connect with colleagues. Registration is essential and seats are limited.
2021 National Tribute and Award Ceremony Invitation
Sometimes it is difficult to put feelings into words. They say a picture can tell a thousand words, so the White Coats Foundation is inviting you to express ‘Your Voice’ by creating a picture, painting, symbol or sending in a photo that represents what clinical trials mean to you.
Perhaps you are a patient that has benefited from participating in a clinical trial or a recipient of an approved medication that is available because of a clinical trial or a health care professional who supports patients on clinical trials or an industry professional who is witness to the impact that medical advances can bring to people’s lives. Whatever your circumstances, the White Coats Foundation want to hear your voice and see your story.
Submission open between 6 April and 3 May
The White Coats Foundation will select a shortlist of entries for further presentation at the White Coats Foundation “Your Voice, Your Story ” public webinar to be held on International Clinical Trials Day-20th of May.
Learn more here: https://whitecoatsfoundation.org/your-voice/
On Tuesday 13th April QUT (Queensland University of Technology) Faculty of Health held their student excellence awards ceremony.
In 2018 as part of our donations program, Bellberry gave support to QUT with the launch of the 3-year Bellberry Biomedical Ethics student prize. The winner of the Bellberry Biomedical Ethics prize for the 2020 academic year was Natasha Vincent, a second-year Bachelor of Biomedical Science student with the highest achievement in the unit. Bellberry passes their congratulations on to Natasha.
Bellberry has a team of office-based staff who support the administrative function of the HREC process. The team includes secretarial, IT and project professionals.
We currently have a vacancy for an HREC Officer.
It is now several months since Bellberry updated its procedures and we are pleased to report that there has been a significant drop in start-up times for additional sites.
The table beneath is a comparator of Jan/Mar 2020 to 2021. These months have been chosen as Jan/Mar may pre-date any COVID related issues sites may have, and in December 2020, the grace period ceased.
| Approval-Month | Count of Applications | Average of Bellberry Days |
| Jan-20 | 32 | 34 |
| Jan-21 | 39 | 13.05 |
| Feb-20 | 55 | 27.72 |
| Feb-21 | 54 | 10.38 |
| Mar-20 | 60 | 20 |
| Mar-21 | 72 | 10.45 |
Amendments are tracking at the same turnaround time in Bellberry days (3.8 days). The updated model’s difference is we now ensure all sites are listed on the one approval letter, as appropriate.
We appreciate the teething issues as sites, sponsors, and our administration tackle the changes together. If you have any questions or you would like to schedule a call with the quality team to discuss the practicality of the changes at your site, please email alisonbarr@bellberry.com.au.
Document Updates
We recently made some minor changes to some of our documents and guidance for researchers. A summary of the changes can be found here.
FAQs relating to the process changes rolled out in late 2020
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The Power of One campaign is run by the White Foundation. The Foundation was established in recognition of the need to raise awareness about the role of clinical trials in advancing medical science and healthcare.
Applications are now open for the Power of One 2021. The Foundation encourages applications that align with their annual research themes. This year’s grant is related to INDIGENOUS HEALTH programs that are either:
- Research for curative medicine and preventive health programs; or
- Programs designed to support consumer and community awareness or engagement in clinical trials.
Further information on the campaign can be found on the White Coats Foundation website