Category: <span>Education and Resources</span>

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.

 

Due to our continued growth, we seek to expand our panel of medical and scientific members on an ongoing basis.  At present we are particularly interested to hear from people with clinical and/or research experience in the following areas:

Knowledge and experience favourably considered for medical and scientific members (category (c) and (f) per the National Statement on Ethical Conduct in Human Research) includes:

Meetings are held on a Wednesday evening.  There is no requirement to attend a regular meeting as attendance is based on Bellberry’s need and member’s availability. Category (c) and (f) members rotate through all HRECs depending on the meeting agenda and type of expertise required. As such, the time commitment is variable, and can be tailored to suit each member.  Some panel members join a Bellberry HREC meeting 3 or 4 times per year, others may join 12 or 15 times.  Interstate members join meetings remotely.

Our online software program enables members to access all relevant documents and investigator and committee correspondence via the internet.

Proposals are available to review 12 calendar days prior to a meeting.  Post meeting matters are required to be dealt with promptly within a 48 hour period.

Bellberry supports education and professional development of HREC members.  Initial induction training is delivered to all new HREC members and ongoing education provided with access to internal events and support for attendance at external events.

From time to time, we require community representatives, pastoral care and lawyer members (category (b), (d) and (e), per the National Statement on Ethical Conduct in Human Research) to join our team.  Members in these categories are required to attend meetings rather than join remotely.

If you are interested in becoming a Bellberry HREC member please complete and submit the Committee Member Application Form.

If you would like further information, please call the Committee Manager Cathy Stevens on 08 8361 3222 or email recruitment@bellberry.com.au

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

PRAXIS: Essential Project Management Skills for Research and Clinical Trials

PRAXIS are today holding their Essential Project management Skills for Research and Clinical Trials course right here in Bellberrys new office premises. The session is an introductory style workshop which covers key processes and strategies in project management. Participants will learn practical and essential skills for effective project management of clinical trials and research more generally. The basic skills of project management gained from this workshop will equip participants to run their projects smoothly and seamlessly; on time and on budget. Participants will walk away with a toolkit of resources that they can rapidly apply to their next project and a renewed sense of confidence! For further information on this course and others run by PRAXIS please visit their website

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.

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: The updated Handbook provides policy guidance on the clinical trials schemes administered by the TGA. Guidance on the notification process for the Clinical Trial Notification (CTN) scheme is available at Clinical trial notification form – user guide. Guidance on the application process for the Clinical Trial Exemption (CTX) scheme is currently under review. Please contact the clinical trials team at clinical.trials@health.gov.au for any further information or clarification.

27 July 2017, The Science Exchange Adelaide

The topic for the evening was Navigating the murky waters of data banks & registries and application of the National Statement.  This topic was selected as Bellberry are receiving a growing number of data bank/registry submissions for review; some simple and some more complex.

The format of the evening were 2 presentations by a Senior Manager at a leading clinical research facility and Associate Professor Annette Braunack-Mayer, Professor of Health Ethics in the School of Public Health at University of Adelaide and Chair of Bellberry Committee F, followed by a Q&A session.

The event was extremely well received with over 50 people, many from interstate, in attendance.  Many thanks to all our members for their invaluable input and to our guest speakers who made the sessions both interesting and thought provoking.

Bellberry CEO Kylie Sproston, PRAXIS CEO Melanie Gentgall and Bellberry Operations Manager Trina O’Donnell all attended this annual event held in Melbourne this week.

Bellberry and PRAXIS hosted a joint exhibition and were delighted to meet new contacts along with existing colleagues and friends. Alongside the 3 day program this year the event also hosted International BioFest which aimed at providing a variety of functions to enable participants wider networking opportunities as well as strengthening existing relationships.

Next Month……..

Please look out for both Bellberry and PRAXIS next month at the Australasian Ethics Network Conference (23-25 November) held here in Adelaide.

 

REGISTRATION OPEN AND PROGRAM NOW AVAILABLE!

Join the discussion at Australia’s pivotal Research Ethics, Governance and Research Integrity meeting

CLICK HERE FOR PROGRAM DETAILS

 

WORKSHOP PLACES ARE FILLING FAST

Join us at the iconic SAHMRI building for opening night drinks, networking and an exciting guest panel discussion. The conference dinner will also be held in another of Adelaide’s most majestic locations.

More details coming soon!

Register now to ensure you don’t miss out, places are strictly limited

REGISTER NOW

conference team contact
Ms Lesley Woods
AEN 2016 Conference Secretariat
PO Box 764
MITCHAM SA 5062, Australia
Telephone: +61 (02) 8177 2215
Email: reg@themeetingpeople.com.au

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)

Join the discussion at Australia’s pivotal Research Ethics, Governance and Research Integrity meeting

  It is a pleasure to invite you to join us at the 2016 AEN Conference to be held in Adelaide’s rapidly growing research hub. The conference is brought to you as a result of the collaboration of Bellberry, PRAXIS Australia and the Australian Research Management Society (ARMS), in conjunction with our sponsor, the University of South Australia.

Program release coming very soon!

The AEN 2016 Conference will seek to explore in detail how the research and research ethics communities in Australia can prepare for innovation by better understanding what kinds of challenges this era of innovation brings our way, how we can utilise innovation to improve processes, and importantly to identify and address the ethical implications of those innovations. Secure your place in one or more of the pre-conference workshops and learn from the various expert panel discussions and interactive sessions planned throughout the meeting on a diverse range of relevant topics.

REGISTER HERE NOW!

conference team contact Ms Lesley Woods AEN 2016 Conference Secretariat PO Box 764 MITCHAM SA 5062, Australia Telephone: +61 (02) 8177 2215 Email: reg@themeetingpeople.com.au

13 & 14 August 2016, The Science Exchange Adelaide

This year as a representation of the growing areas of clinical trial activity, the themes of the HREC Member Education Weekend were Genetics and Stem Cells. The event was extremely well received with nearly 70 people, many from interstate, in attendance. Excellent speakers presented extremely interesting sessions throughout the course of the weekend. Many thanks to all our members for their invaluable input and to our guest speakers who make the sessions both interesting and thought provoking.

AEN Conference Nov 2016

CALL FOR PAPERS INVITED FROM ACADEMIC AND HEALTH CARE RESEARCH ETHICS AND RESEARCH SECTORS

It is a pleasure to invite you to join us at the 2016 AEN Conference to be held in Adelaide’s rapidly growing research hub. The conference is brought to you as a result of the collaboration of Bellberry, PRAXIS Australia and the Australian Research Management Society (ARMS), in conjunction with our sponsor, the University of South Australia.

We encourage you to visit the conference website to find out how to submit your abstract and to learn more about the various conference themes.

http://themeetingpeople.com.au/aen2016/

The AEN 2016 Conference will seek to explore in detail how the research and research ethics communities in Australia can prepare for innovation by better understanding what kinds of challenges this era of innovation brings our way, how we can utilise innovation to improve processes, and importantly to identify and address the ethical implications of those innovations.

Registration and session information coming soon, including an announcement of exciting key note speakers.

conference team contact
Ms Lesley Woods
AEN 2016 Conference Secretariat
PO Box 764
MITCHAM SA 5062, Australia
Telephone: +61 (02) 8177 2215
Email: reg@themeetingpeople.com.au

11 – 12 May, Sydney

Bellberry were again delighted to exhibit and present at this popular two day event. CEO, Kylie Sproston, Operations Manager Trina O’Donnell, National PICF Project Manager Simon Windsor and Committee Chair Annette Braunack-Mayer all attended this event along with Praxis CEO Melanie Gentgall.

Kylie Sproston chaired the day 1 session, ‘Emerging Issues in Ethics’ at which Simon spoke about the National PICF, and Annette about Registries. Kylie also presented at the day 2 session ‘Real Industry Mashup: Clinical trials, social media, digital marketing and beyond’

The Bellberry team found the event educational and informative and a great way to catch up with our clients and meet others in the industry.

Simon at ARCS
National PICF Project Manager Simon Windsor at the Bellberry ARCS stand

Annette Braunack-Mayer presenting at ARCS
Annette Braunack-Mayer presenting at ARCS

Simon Windsor presenting at ARCS
Simon Windsor presenting at ARCS alongside Kylie Sproston

The new National PICF website and associated documentation was launched yesterday at the annual May Vic Health Workshop entitled ‘Innovations in Clinical Trials and Research.’

Bellberry have sponsored this initiative and CEO Kylie Sproston along with PICF Project Manager Simon Windsor attended the event held in Melbourne with Simon presenting a session entitled ‘Talk Read and Write: a three tiered Participant Information and Consent Form’.

The session and information presented were extremely well received and both Kylie and Simon welcomed feedback from workshop delegates on the new PICF.

If you would like further information on the new National PICF please visit www.nationalpicf.com.au

National PICF ABC - Logo (002)