Category: <span>Quality Activities</span>

Based on feedback from sites and sponsors, and in our aim for continuous improvement, Bellberry has made further attempts to streamline progress reporting. The change in reporting will make it easier for sites and sponsors to control and manage the due dates for progress reports and consolidates the two processes of progress reports and extension (PRE) requests to occur at the same time. Bellberry has moved to one-year terms of approval for all studies approved from 29 April 2020. The DD-MM cycle of the lead site will determine the due date for PRE submissions, with an exception to sites approved within 60 days of the due date. 60-day exception rule explained below: The following will occur: The guidance sent to sites in early 2020 stated the changes would not impact older studies. This advice has changed. Please continue reading. Many studies have two, three, and five-year terms of approval. When extension requests are submitted for studies approved before April 29, 2020, they will move to the one-year term of approval. Often, sites have a different term of approval expiry to their progress report due date. These dates will be realigned, and all sites will move to the reporting cycle of the lead site. For some sites, this will mean a complete change of month and shorter than a one-year term of approval for the next reporting cycle. Date realignment explained below: The following will occur: While the last two sites now have less than six months before their next report is due, it will bring all sites under the one reporting cycle. It also reduces the need to submit a progress report and an extension request as they become the same item. In the event the lead site has closed, the advice does not change. The PRE will align with the initial approval date cycle (DD-MM). Once your site is updated and realigned, all sites will receive a reminder email at 30, 14 and 7 days before the due date. Sites will notice the change to their reporting from June 01, 2020. Related documents For comprehensive guidance on Bellberry’s reporting requirements, please see MAR G4 Progress and final reports, available at the Bellberry website: monitoring approved research

ENROL NOW!

PRAXIS’s small team has received over 1000 enrolments for these sessions and as such processing of registrations may be prolonged. It’s likely that PRAXIS will need to plan new dates so please visit the PRAXIS website regularly!

Two of five of our 2019 projects are now in the launch phase or complete: Project 1:  Consumer Involvement and Engagement The Toolkit was launched at the ACTA International Conference on 4-October!! The Toolkit is a joint initiative between Australian Clinical Trials Alliance (ACTA) and Clinical Trials: Quality & Impact (CT:IQ) providing practical advice for researchers and research organisations wishing to conduct patient-centred clinical trials. Through the use of an interactive map, the Toolkit provides guidance and tools to help plan, deliver, evaluate and report consumer and community involvement and engagement activities. The Toolkit’s focus is clinical trials, however, much of the content is relevant to other types of health research. Development of a living repository accessible via an online platform provides a mechanism to share resources both locally and internationally in the future. https://involvementtoolkit.clinicaltrialsalliance.org.au/ Project 2:  eConsent in Clinical Trials ‘Opportunities to enhance patient engagement’ This project was launched to CT:IQ members on the 24-Jun and was launched publicly at the AusBiotech International Conference on 31-Oct.  This project, completed in partnership with Chrysalis Advisory, described the current use and adoption of eConsent, investigated barriers to the uptake of eConsent within the Australian clinical trial context and created actionable insights to support increased adoption of the technology. Project 3:  Early Phase Trials Best Practice This project will identify, summarise and test recommendations for best practise conduct of early phase clinical trials.  The team has just completed developing an excel based self-auditing checklist tool.  Testing of the checklist tool with end-users is about to begin.  The final checklist will be released to our members at the end of the year and publicly launched soon after. Project 4: Clinical Trial Site Recruitment This project will develop best practice guidelines for optimising clinical trial recruitment which are broadly applicable and translational at the site level.  The project team has now finished drafting best practice guidelines and is currently looking at online tools to enable this information to be easily accessible to clinical trial site staff.  The tool will be tested and released to our members at the end of the year and the associated website launched soon after publicly. Project 5:  Guidelines for Biomarker-directed therapies in personalised medicine: Tools for assessment. The primary objective of this project is to guide policy makers and clinicians to what evidence is needed to make treatment recommendations for individual patients, especially linked to their Biomarker profiles.  A systematic review of the current guidelines is underway and the first of two expert meetings was held on the 16th of November at the NHMRC CTC to refine the nature and scope of the problem.
CT:IQ Membership CT:IQ is the only initiative where government and clinical trial stakeholders can come together to undertake meaningful sector improvement initiatives. If you or your organisation is interested in improving the impact, quality or efficiency of the way clinical trials are conducted get in touch with CT:IQ’s Programme Director, Leanne Weekes, leanneweekes@ctiq.com.au and check out our website: https://ctiq.com.au
CT:IQ Programme Level Updates CT:IQ has presented five times at four conferences over the last quarter discussing CT:IQ sector improvement project progress; ARCS 2019, BioConnections 2019, the ACTA international Conference and AusBiotech 2019 in addition to participating in a second MTPConnect podcast and a Praxis Webinar.

25 – 29 November, Queenstown, NZ

‘Shared horizons: Optimising drug response to improve patient outcomes’

The Meeting offers the opportunity to network with colleagues and other leading international and national scientists and academics at both social and scientific activities. A key feature of the Meeting is the chance for early career researchers and research students to present their research findings in poster and oral presentations sessions. ASCEPT-PAGANZ annual awards and prizes will also be presented at the Meeting. The program of plenary lectures, symposia and workshops, oral presentations and posters will be scientifically stimulating and lead to new collaborations and research opportunities. Bellberry are delighted to be a major meeting sponsor of this event and we look forward to seeing you there. For further information please visit the ASCEPT-PAGANZ event website.

AAHMS (Australian Academy of Health and Medical Sciences) is the impartial, authoritative, cross-sector voice of health and medical science in Australia. They are an independent, interdisciplinary body of 357 Fellows (soon to be 399) – elected by their peers for their distinguished achievements and exceptional contributions to health and medical science in Australia. Collectively, they are a representative and independent voice, who engage with the community, industry and governments. The Academy is uniquely positioned to convene cross-sector stakeholders from across Australia to address the most pressing health challenges facing society.

AAHMS was formalised in 2013 as a result of a gap in the sector for Health and Medical Sciences. At the time four Academy’s existed; Science, Engineering & Technology, Social Science and Humanities but there was no specific Academy for Health and Medical Sciences. So AAHMS was formally established in 2014 with Professor Ian Frazer as President to provide an impartial and authoritative voice for healthcare and medical science practice, to drive policy issues forwards and to provide leadership, inspiration and support to the next generation of budding medical science leaders. AAHMS is governed by an elected Board and Council.

The Academy began with 15 fellows and today has 357 with another 42 being formally welcomed at this year’s Annual General and Scientific Meeting. Becoming a Fellow is a competitive process which can take up to 12 months. Nominations are made through recommendations and peer review and candidates must meet a robust criterion which includes making significant contributions to research. The Academy strives to maintain a Fellowship base made up of a diverse range of expertise and disciplines. Of the 42 new Fellows joining the Academy, 19 are female and 2 are corresponding Fellows from overseas.

Catherine Luckin is the current CEO of AAHMS and joined the Academy in 2018 when the Brisbane office was set up. Catherine has a decade of experience supporting research and innovation, particularly in the health and medical sciences – through roles in policy, public affairs, strategy and international relations. Until December 2016, she was Head of International at the Academy of Medical Sciences (AMS), the UK’s National Academy for health and medical research. She led a team of staff to deliver initiatives designed to respond to global health challenges, influence policy and promote international mobility, connections and capacity building. Catherine as the first CEO that AAHMS has had leads a dedicated Secretariat team, manages Governance and policy issues and drives forward the Academy’s strategic objectives.

This year’s 5th General and Scientific Annual Meeting will be held 9 – 11 October in Perth. The Academy has 5 state branches covering all the states and territories and this event is a great opportunity to brings all of the Fellows together. The theme of the meeting this year is ‘Infectious diseases: threats old and new’. It has been 100 years since the Spanish Flu arrived in Australia and from here, the meeting will consider the national and global prospects for tackling current and emerging threats – known and unknown. Questions to be explored include:

What are the prospects for eliminating infectious diseases?
How will the world tackle the next pandemic – ‘Disease X’?

The meeting will also celebrate Professor Ian Frazer’s Presidency and welcome incoming President Professor Ingrid Scheffer. Professor Scheffer is an Australian paediatric neurologist and senior research fellow at the Florey Institute of Neuroscience and Mental Health. She has made several major advances in the field of epilepsy research and is credited with finding the first gene implicated in epilepsy. Prof Ian Frazer will maintain his position on the AAHMS Board and will continue to remain heavily involved in the Academy.

Bellberry is delighted to continue to support the Academy and will again be sponsoring this year’s General and Scientific Annual Meeting.

Bellberry is delighted to be both sponsoring and exhibiting at this years ACTA International Clinical Trials Conference, 2 – 5 October, Sydney.

The conference brings together Australian and international experts in the cutting-edge design and conduct of clinical trials and registry custodianship, healthcare funding, policy and regulation, health care service delivery, health information technology, health economics and patient advocacy.

The Conference theme is ACTA’s reason for being – Better Health Through Best Evidence – providing a platform for national and international stakeholders to share global advances in the development of self-improving healthcare systems.

The program will address:

Bellberry is proud to be a part of this valuable event which is integral to the advancement of clinical trials research in Australia and internationally. We look forward to seeing you there!

Find out more and register on the conference website

CT:IQ Webinar: Wednesday 18 September 2019, 13:00 – 14:00 (ACST)

Click here to enrol: http://praxisaustralia.com.au/enrol-now 

CT:IQ is MTPConnect and member-funded Clinical Trials sector improvement initiative with government support from the TGA, PBAC, MSAC, NHMRC and the Office of Health & Medical Research within the Department of Health.

CT:IQ’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 – our mission is to get Australia Thinking Smarter about the conduct of clinical trials!

CT:IQ’s vision is to act as a platform for all stakeholder voices to come together.  CT:IQ’s membership is comprised of 40 diverse organisations with national and international representation from government, pharma, device organisations, CROs, academia, medical research institutes, phase 1 units, CTNs, advocacy groups and consumer representatives.  CT:IQ is the only initiative where government and clinical trial stakeholders in both investigator-led and industry trials sectors can come together to undertake meaningful sector improvement initiatives.  This will lead to a more meaningful integration of clinical trials into the Australian health care system, resulting in better healthcare and better outcomes for patients, participants and the community.

CT:IQ are conducing five projects in 2019 selected and prioritised against the needs of the sector by our Steering Committee members in the following areas:

During this webinar CT:IQ Director Leanne Weekes, will provide updates on all five 2019 projects.

This interactive session will also be an opportunity to ask questions and find out more about CT:IQ and how to get involved.

The CT:IQ Steering Committee has a small number of remaining seats therefore your participation is a rare opportunity for your organisation to have a voice.

ClinTrial Refer Webinar: Tues 24 September, 11:00 – 12:00

Click here for further information on the ClinTrial Refer Webinar (scroll to the bottom of the page)

Bellberry along with CT:IQ is sponsoring this 2-day conference in Melbourne. Jerneen Williams, Early Phase Clinical Trials Manager at Bellberry, will be attending along with CT:IQ Programme Manager Leanne Weekes. Bio Connections Australia is an annual, national event designed to foster the growth of early phase clinical research in Australia. For more information on the conference please visit the Bio Connections website.

The Bellberry team were recently invited to visit SAHMRI to see and hear first hand the research activity that is underway with the aid of Bellberry funding.

Back in 2014 SAHMRI’s Mind and Brain Theme Leader, Prof Julio Licinio was awarded the inaugural Bellberry Mind and Brain Fellowship. The recipient of the Fellowship was Dr Michael Musker. The Bellberry team met with Dr Musker who has worked on several initiatives since 2014 including a highly innovative project on gene-environment interactions. Dr Musker talked with the team about the projects that he has worked on since coming to SAHMRI in 2014 including the following:

The team also met with Prab Takhar, Director of SAHMRI’s cyclotron. In 2017 Bellberry launched its partnership with SAHMRI to establish the Bellberry Molecular Imaging Program. This program studies how diseases may behave differently in individual patients, with important implications in the development of a more personalised approach to disease diagnosis and treatment. Molecular imaging has enabled the ability to use radiopharmaceuticals to study the functionality and progression of diseases ranging from bone, breast and prostate cancers, through to Parkinson’s Disease, Epilepsy and Alzheimer’s Disease.

Read more on Prab’s recent work in the Bellberry Molecular Imaging Unit:

https://www.sahmri.org/research-theme/news-246/

 

CT:IQ Overview

In 2018 Bellberry Ltd, ACTA, NHMRC Clinical Trials Centre and The George Institute have formed a consortium called Clinical Trials: Impact & Quality (CT:IQ). CT:IQ’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 acts as a platform for all stakeholder voices to come together.  By forming project teams to identify challenges, they aim to explore, solve and implement solutions in both investigator-led and industry trials sectors.  This will lead to a more meaningful integration of clinical trials into the Australian health system, resulting in better healthcare and better outcomes for patients, participants and the community as a whole.  To participate or for more information visit www.ctiq.com.au or email info@ctiq.com.au

Project 1:  Consumer Involvement & Engagement (CI&E) Toolkit

CI&E is critical to fostering consumer access to innovative therapeutic solutions and delivering better health outcomes for patients, participants and the community.  This collaborative project between CT:IQ and the Australian Clinical Trial Alliance (ACTA) will foster best practice across the research sector by providing a mechanism to share resources both locally and internationally via a public website.  This platform will provide tools to support CI and CE within Clinical Trials (CTs) activities and seek opportunities to increase the awareness, knowledge and capacity of the wider community.  The content specialist, Tanya Symons was appointed in April, along with platform developer, Orchard.  The first workshop socialising some of the tools was held on 6 May.  The website will be launched in Quarter 4.

Project 2:  eConsent adoption:  Barriers and Recommendations

eInformation and eConsent improve the quality of the consenting experience, increases patient engagement as well as the accessibility and opportunity for participation, however currently there is limited uptake in both the investigator-initiated and industry-led CT sector in Australia and globally.  This project aims to understand the barriers to eConsent adoption in Australia and to produce practical recommendations and actions to increase uptake of e-information.  The results will be released at the CT:IQ Steering Committee Meeting 24-June!

 Project 3:  Early Phase Trials Best Practise

There is currently no single source of best practice outlining expectations for the conduct of early phase, and crucially Phase I Clinical Trials in Australia.  This project aims to identify, summarise and test recommendations for best practise conduct of early Phase Clinical Trials.  This project utilises the wealth expertise and experience from the CT:IQ Steering and Executive Committees including NSW Health, Linear, CMAX, Macquarie University, Biotronik Orygen, Centre for Biostatistics and Clinical Trials at the Peter MacCallum, Cancer Trials Australia, Icon Cancer Group, a consumer representative, VCCC, the Medical Technology Association of Australia and Bellberry Ltd. The project is in the evidence-gathering phase.  The guidance will be released in December 2019.

Project 4:  CT Recruitment:  Barriers and Recommendations

This project is focused on addressing sub-optimal rates of Clinical Trial participation and will provide practical guidance for sites for optimising recruitment which is broadly applicable and translational.  Similar to Project 3, this project is also in the evidence gathering phase with a survey on the barriers and enablers for Clinical Trial recruitment launching within the month so please keep an eye out!

 Project 5:  Guidelines for biomarker-directed therapies in personalised medicine: Tools for assessment

Currently, there is a lack of guidance around the criteria that should be used to assess evidence for individualised/personalised clinical decisions especially linked to patient’s biomarker profile. This collaborative project between CT:IQ, the NHMRC Clinical Trials Centre (CTC) and Utrecht University will develop a theoretical framework which will be valuable for policy makers including the PBAC and MSAC as well as clinicians to optimise patient treatment decisions.  This project is just launching now.

 

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.

As of 2016, Bellberry began working in collaboration with the Viertel Foundation to offer prestigious, high-value 5 year mid-career fellowships to the brightest research talent.

The Senior Medical Research Fellowship and the Bellberry-Viertel Fellowship are intended to be amongst the most prestigious awards available to those who wish to continue a career in medical research in Australia. The Fellowship is an integral part of a scheme that is intended to provide both salary and project grant support for outstanding Australian medical researchers.

The closing date for 2019 application is 30 April 2019. Please click here for more details on the award and visit the Viertel website for further information and application details.

17 -19 March – Melbourne

This years APHA Congress will examine the changing operational environment for private hospitals. Issues such as private health insurance reform, the new National Safety and Quality Health Service Standards (National Standards) and privacy will all be discussed.

The APHA Congress will continue to feature a range of social and networking events that bring delegates and exhibitors together so there are plenty of opportunities to discuss issues with peers and industry partners.

Bellberry CEO Kylie Sproston and Operations Manager Trina O’Donnell are attending this event and look forward to seeing you there!

Bellberry is delighted to share the announcement of 3 Medical Research Fellowships in conjunction with Equity Trustees.

The prestigious annual Sylvia and Charles Viertel Charitable Foundation Senior Medical Research Fellowships have been announced for 2017, committing just over $3.6 million to three researchers undertaking leading edge research into fighting cancer, schizophrenia and antimicrobial resistance.

The Bellberry-Viertel Fellow for 2017 is Associate Professor Di Yu from the Department of Immunology and Infectious Disease, Australian National University.  A/Prof Yu will work on investigating the differentiation and function of novel cytotoxic T cell subset, with the aim of harnessing this newly identified cell type to come up with new ways to treat diseases including HIV and B cell lymphoma.

Click here for the full Media Release – 15 Nov 2017

Applications for 2018 open: Annually on the first day of February .

Applications close: Annually on the last day of April.

Information about the application process can be found here