eProtocol

Bellberry receives Australian first recognition

Bellberry awarded AAHRPP accreditation

Bellberry has become the first organisation in Australia to achieve international accreditation for excellence and ethically sound processes in running Human Research Ethics Committees (HRECs).

The recognition has come from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which is based in the USA. The AAHRPP site accreditation team visited Australia to conduct an extensive review of Bellberry’s operations earlier this year.

Bellberry’s CEO Kylie Sproston has welcomed the news.

“This is a huge boost at a time when Bellberry is firmly focused on the safe continuation or adjustment of current clinical trial activities and the welfare of participants on those trials,” Ms Sproston said.

Elyse Summers, CEO and President of AAHRPP said that AAHRPP’s Council on Accreditation (Council) met (remotely) and awarded Bellberry full AAHRPP Accreditation.

“The site visit team and Council were highly impressed with Bellberry’s robust human research protections program (HRPP), which serves as an excellent model in Australia for the ethical review of and education about research involving human participants,” said Ms Summers.

Ms Sproston said, “The accreditation is testament to all the hard work undertaken by our staff, the broader Bellberry team, our HREC Community, and the researchers that we serve”.

The primary purpose of AAHRPP accreditation is to strengthen protections for research participants. However, the benefits of AAHRPP’s comprehensive approach extend beyond participants to the research enterprise as a whole. Each accreditation advances that objective and helps build public trust and confidence in research.

Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs in the US. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process.

AAHRPP-accredited organisations have been recognised to have more efficient operations, provide more comprehensive protections, and produce high-quality data. AAHRPP-accredited organisations also tend to have more streamlined, effective policies and procedures.

AAHRPP recently published their May newsletter which includes an article on Bellberrys accreditation: Read Here (pdf) or at https://www.aahrpp.org/

Perth based not-for-profit clinical trial facility, Linear, got early warning on the seriousness of COVID-19 thanks to a staff member who was visiting China and staying in the province next to Hubei. The trained nurse who is the Head of China Business Development for Linear, not only played a crucial role in alerting the organisation about the rapidly developing situation in Wuhan, but also managed to secure 400,000 N95 medical masks for her state of WA from China.

This is a neat illustration of what Linear’s CEO, Jayden Rogers, believes has put Linear in a good position to deal with the challenges presented by COVID-19. For him it’s all about the people and long term investment in innovation and culture.

“The true north for us, when COVID first hit, was always going to be to protect our volunteers and staff, that was going to be the key to all the decisions that our teams made,” he said. “I think the reason it has worked so well is because of our investment in our people. And that’s not something you can just turn on, we put a lot of effort into training and development and recently people have shown how agile, adaptable and flexible they can be when change is coming at a rate of knots.”

Putting volunteers and staff first meant reducing capacity on healthy volunteer trials. This resulted in less people undertaking trials so participant safety could be ensured. A number of healthy volunteer trials were slowed down or delayed. This had to be communicated to sponsors, but overwhelmingly they have been supportive of Linear’s approach. A strong focus was placed on those undertaking trials who were vulnerable.

“We have some very vulnerable patient groups in our clinic, we engaged very closely with specialists and the patients to understand the risks that COVID presented to them. In many cases these patients (for instance on oncology trials) are in such a challenging situation that the risk of not being able to access a trial is worse than the risk of COVID itself.”

With that in mind, Linear doubled down to protect vulnerable patients, by effectively locking down the clinic well before the practice became common, and before any domestic or international travel bans were put in place. A reduction in the overall capacity of the clinic was put in place as well as the creation of separate trial zones. Distancing between each clinical trial participant occurred by leaving an empty bed between each participant. Staff teams were divided up and worked separately to ensure participant safety.

“Thanks to our investment in technology we could move to remote monitoring, which means that only the people who must be in the clinic are there. We made the tough decision with our patients that family members couldn’t accompany them unless absolutely required. And we could get a majority of our staff working from home very rapidly.”

Another reason to continue trials for vulnerable patients was to help them stay out of hospital so that more beds are free for anyone who may get infected with the virus. For Linear it was vital to be well across the local situation in Western Australia. A local private company was engaged to undertake COVID-19 screening for Linear’s clinic, but only once it was established that this was not going to impact supply of COVID-19 tests for the state authorities.

“The testing has given us another tool in our arsenal of screening assessments to give us a higher level of comfort that we are unlikely to have anyone in the clinic who is positive to COVID-19,” said Jayden. “We also engaged very early with the Sir Charles Gairdner Hospital and the wider medical community in terms of what we could do around the broader response to COVID-19. We brought in experts such as infectious disease and emergency medicine specialists to evaluate what we were doing. That was really helpful and gave us a lot of comfort on the processes that we were putting in place.”

But Jayden is keen to point out that it’s not just Linear that is going above and beyond when it comes to responding to COVID-19. He believes that the whole sector across Australia is doing good work as well as the authorities. However, we are at the beginning of a long battle. Linear has a planning ahead team for COVID-19 as well as a COVID-19 team that meets daily.

“It’s about continuing to innovate and find ways not to just cope with it, but to fight it. That’s been part of our mantra. It’s a psychological battle as much as it is an infectious disease. So it’s important to fight it in as many ways as possible. I think we are privileged in some ways to work as an industry that is at the heart of that fight.”

While acknowledging that the sector as a whole is doing great work in dealing with the challenges of the pandemic Jayden has three tips that have helped steer Linear’s course ahead of the curve.

  1. Ongoing investment in people, culture and technology is crucial
  2. Listen to what the data is saying and move quickly
  3. Communication is key with all stakeholders including trial participants, staff, investigators, sponsors, institutions, suppliers and authorities

Linear has recently announced it will be an Australian testing site for a COVID-19 vaccine and has put a call out for healthy volunteers.

(Interview and article on behalf of Bellberry by Alison Rogers, Living Stories)


For more information about practical adjustments to modify Clinical Trials for the COVID-19 period please refer to:

For queries and support,  please contact the Bellberry team via 08 8361 3222 or covidsubmissions@bellberry.com.au

ACTA, PRAXIS, ARCS and CT:IQ collaborate to host clinical trials online forum launching on International Clinical Trials Day, 20 May 2020

Australian Clinical Trials Alliance (ACTA), PRAXIS Australia, ARCS Australia and CT:IQ have come together to create Beyond COVID-19: a solution-focussed forum after identifying a need for the clinical trial sector to collaborate and share information.

Beyond COVID-19: a solution-focussed forum is an exciting new initiative for people working in clinical trials to share their learnings and assist with solutions.

It will be open for anyone to read, and registration to participate is simple. Clinical trialists can instantly share their knowledge, assist with responses and point each other to useful resources or contacts; from ethics to telehealth, pharmaceutical supply to remote monitoring. Solving problems is at the heart of clinical trials, and the COVID-19 pandemic has seen the sector becoming more agile; adapting existing trials, finding new ways to commence planned trials, or moving quickly to help test treatments and solve the riddles of coronavirus.

The pathway out of the pandemic will also see some twists and turns and more problem-solving for the sector, where the Beyond COVID-19: a solution-focussed forum will continue to be a sharing space.

Join us all at 1:30 pm AEST on International Clinical Trials Day, Wednesday 20 May, for the official launch of Beyond COVID-19: a solution-focussed forum.

A guest panel of experts will be live on the forum for the launch to offer their perspectives on your questions about clinical trials through COVID-19 and beyond.

Please register beforehand – today.

The forum will be hosted at clinicaltrialsalliance.org.au/forums/

#clinicaltrials #COVID19 #BEYONDCOVID19

Report of an international workshop convened by Bellberry, held on November 18-20, in Sydney, Australia

In November 2019 Bellberry were delighted to host the “Challenges of Valuing and paying for Combination Therapies in Oncology” international workshop in Sydney.

This event brought together over 50 experts from around the world from a range of stakeholder groups to discuss the challenges associated with valuing and paying for combination regimens in oncology. All aspects of the workshop programme were overseen by a Scientific Committee and were chaired by E/Prof Lloyd Sansom.

The workshop was followed by a one-day open day meeting where the deliberations and conclusions of the expert panel presented and debated amongst a wider local audience.  The workshop outcome was the development of an agreed statement of good practice, guidelines on approaches and a clear agreement on any required next steps.

The full workshop report can be viewed here

To assist and guide you through this challenging time, Bellberry will continue to gather, distil and deliver the latest information relevant to the oversight of clinical trials during the COVID-19 pandemic.

We will be providing new information as it becomes available. Click here to access the latest information https://bellberry.com.au/covid-19-updates/

Earlier this week Bellberry CEO Kylie Sproston joined Tam Nguyen (St Vincent’s Hospital Melbourne) and James Cokayne (NSW Health) to speak at one of ARCS Australia’s series of webinars on COVID-19.

The session was entitled ‘Ethics Committees and Governance’ and topics discussed by the panel included how to manage the continuation of the safety and welfare of participants during the pandemic along with tips on how to best manage your trial during this time.

The full webinar can be viewed here.

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!

Bellberry has been monitoring the development of the COVID-19 outbreak over the last few weeks. As the Australian situation has now moved past the 100 patient point, we would like to share with you information about our planning and services.

Research Participant Welfare & Study Changes

As the COVID-19 situation escalates in a number of jurisdictions around the world and within Australia, many Clinical Trial Sites and Sponsors are considering actions to be taken to protect the welfare of trial Participants and to support the continuation of on-going trials.

Bellberry has developed a list of suggested topics for planning purposes. This list should not be considered to be complete, and additional considerations are likely to emerge as the situation continues to develop. Not every topic will be relevant to every trial. They are however intended to be a helpful starting point when considering planning for individual sites and trial situations.  Click here to download.


Operational HREC Activity

The COVID-19 situation has required Bellberry to rethink our Business Continuity Planning, moving from plans that recreate the whole organisation in a new location, to the ways in which we will continue to run our services while the team is wholly dispersed.  We have the technology in place to allow this to happen and have been testing fully remote working techniques over the last 2 weeks.  These tests cover the executive, the administration, and the function of the HREC, along with the heart of the operation: the HREC meeting itself.  We are learning from each series of tests, and are confident that we will be able to continue to offer support and services in the range of possible restricted scenarios ahead.

Bellberry has a schedule of 3 HREC meetings per week, and will continue to support these meetings in a way that protects the safety of our HREC members and operational team.


Business Continuity Planning for HRECs and Institutions

Around the country, health systems are reprioritising their workloads in anticipation of the scenarios ahead.  In light of that, a number of institutions have contacted Bellberry requesting information about utilising Bellberry HRECs as a Business Continuity backup for their own HREC.

Bellberry can provide interim support to institutional HRECs and Research Offices: on a long-term, short-term or ad hoc basis.

Please contact Trina O’Donnell, Operations Manager, 08 8361 3222 if you would like more information about this service.


Emergency COVID-19 related Study Reviews

Bellberry has experience of emergency, fast-track reviews of pandemic-related studies.  Historically, these reviews have been completed within a few days.  Bellberry HRECs also have the depth of experience with routine infectious disease and vaccine studies, such as seasonal flu and diagnostics.

The Bellberry HREC panel includes members with appropriate targeted expertise, including infectious disease, vaccine development, pharmacology, toxicology and immunology.  We have confirmed availabilities in the next weeks and months to allow us to support COVID-19 related developments as emergency reviews.

These reviews will be fast-tracked as emergency meetings in addition to the scheduled programme of meetings.  We have received contacts about a number of COVID-19 studies, and will play our part in supporting fast-track development.  Contact Trina O’Donnell, Operations Manager on 08 8361 3222 for more information.

Bellberry will continue to monitor the emerging situation and will provide regular updates.  In the meantime, for any questions, please contact the team at covidsubmissions@bellberry.com.au or 08 8361 3222.

Research Participant Welfare & Study Changes

As the COVID-19 situation escalates in a number of jurisdictions around the world and within Australia, many Clinical Trial Sites and Sponsors are considering actions to be taken to protect the welfare of trial Participants, and to support the continuation of on-going trials.

The following are suggested topics for planning purposes. This list should not be considered to be complete, and additional considerations are likely to emerge as the situation continues to develop. Not every topic will be relevant to every trial. They are however intended to be a helpful starting point when considering planning for individual sites and trial situations.

Participant communication
Your participants may be reluctant to attend trial visits in a hospital setting, or to a busy clinical practice, or to use public transport to reach you.  Your participants may have questions about how their trial will continue in light of any local outbreak.  In time, you are likely to have participants placed in self-isolation or quarantine.  Participants will undoubtedly have questions about what the emerging pandemic means for their trial participation.  Consider proactively supporting your participants with an FAQ or a helpline contact.  Establishing lines of communication will assist if further pandemic developments trigger additional changes in the coming weeks.

Access and continuity of supply
Consider how to assure ongoing access to trial products and any other items required for delivery of the trial protocol.  Consider whether participants might need a larger supply of investigational product to cover any period of uncertain access.  Consider whether and how that might be dispensed and delivered in a way that minimises risk to participants. Many sites will hear from Sponsors in the coming days and weeks, as they deploy their pandemic planning. Please speak to the HREC for support with amendments, violations or safety reports.

Protocol amendments or deviations
Where changes are anticipated, reach out early and proactively to discuss these with the HREC.  Some investigators are exploring a reduction in protocol-mandated study visits, use of remote consultations and alternative dispensing.  These can be documented proactively in an Amendment for the HREC to review or may be submitted as a Protocol Violation if more urgent changes are required for the safety of participants.

Possible amendments
As the situation is still developing, it may be appropriate to consider substantial changes for a “what if” scenario that might never occur.  In these circumstances, the HREC will consider scenario planning with anticipated changes, and articulation of when and how you would choose to deploy that amendment.  Bellberry HRECs will work with you to ensure sites can make changes in this volatile and rapidly changing environment. Consider submitting a ‘Plan B’ amendment now so that you’re pre-approved to move to new processes if and when you need to.

Participant monitoring
Consider the continuation of participant monitoring if quarantine or isolation measures are required.  Some sites already make use of remote technologies, which are likely to see broader use in the coming weeks.  If you are considering remote technologies you should check whether that method is appropriate and accessible to all participants.  Speak to the HREC about any amendments required.

Health system reprioritisation
Consider whether any location changes might be needed to support the ongoing monitoring of participants.  In some cases, alternative pathology pathways are being explored, along with alternative pharmacy arrangements.

Site screening and travel restrictions
Daily updates on countries considered at risk can be found at health.gov.au, along with advice for travel screening and access restrictions.  This list is changing frequently, so please ensure that you check in with it often.

Signatures
As the use of remote working takes hold, we are likely to see delays in getting hold of wet ink signatures.  Bellberry supports the use of electronic signatures and would encourage you to consider using them even if you haven’t before.

Pandemic Planning
In rapidly-changing scenarios such as the one facing Australia right now, decisions you make today may be out of date by tomorrow.  Consider putting time aside on an on-going basis to manage changes required as the situation develops.

Quality of documentation and reporting
We anticipate a large number of changes to current practice and approved protocols as this situation evolves.  Bellberry HRECs will support you to process amendments, violations and safety reports as they arise.  In such a rapidly-changing situation, it is critical that you keep good records to support compliant reporting.

Safety of trial participants
Participant safety is always our prime focus.  At a time like this, sites should be prepared to re-evaluate trial activities and discuss individual trial participation if the risk profile changes.

Sites running trials approved by Bellberry HRECs are encouraged to reach out early for support.

COVID-19: Considerations for Clinical Trials (printable pdf format)

Bellberry is delighted to announce the recent registration and certification of 4 new HRECs H, I, J and K bringing our total number of HRECs to 12. This enables us to support up to 3 HREC meetings per week.

Full details of all our Committee’s can be found on our HREC page.

 

L to R: Anthea Hall, Phoebe Manual, Micheala Singe, Natalie Brown, Alison Branford and Alison Young

Early last year Bellberry adopted the Early Phase Clinical Trial (EPCT) reviews for NSW public health sites and during that time submissions have steadily grown.  To enable us to support this growth along with organic business growth, we are delighted to announce that we have recently recruited additional staff.

Joining the administration team we welcome 5 new HREC Officer’s: Phoebe Manuel, Anthea Hall, Micheala Singe, Natalie Brown and Ali Young. We also welcome Alison Branford to the new role of  HREC Co-ordinator.

Phoebe is a graduate of Pharmaceutical Science. During her university degree, she undertook work experience in a university chemistry research laboratory and at a clinical trials unit and completed a placement at an overseas pharmaceutical company. She also worked in a pathology laboratory for a year as a technical assistant.

Natalie has spent the last 12 years of her career working in administration roles within the medical field and not-for-profit organisations including Reception, Office Management, Operations and Committee Management.  Natalie worked at The Australian Medical Association (AMA(SA)) prior to coming to Bellberry.

Michealea has had a varied career across multiple industries including Incident Coordinator, Document Controller and Operations Support Coordinator at a major not-for-profit organisation, Legal Secretary at a federal government agency and Network Service Manager for a national real estate franchisor.

Anthea has come from a background in medical research administration and has an Honours Degree in Health and Medical Science from the University of Adelaide.

Ali is a skilled administration and personal assistant with a background in Commercial Property. Her passion for helping people and dance teaching inspired her to change career path and focus on the medical and health industry.

Alison Branford comes to Bellberry with over 30 years of experience working in the medical industry. She has worked in varying administrative and managerial roles during this time.

The new team members are a great asset to Bellberry bringing with them a wealth of knowledge and a diversity of experience. We welcome them all to the Bellberry community!

Melanie Gentgall, CEO of Praxis Australia, has been shortlisted for Pro Bono Australia’s Impact 25 awards.  These awards seek to recognise and celebrate the amazing people delivering incredible outcomes in the Not For Profit sector.

Through Praxis, Bellberry seeks to support education that in turn delivers on our core objectives of improving the quality, efficiency and effectiveness of research and the welfare of research participants.  Melanie joined Bellberry to explore and establish this education initiative and has been the energetic custodian that has overseen its transformation into the independent NFP Praxis that you see today.

Bellberry is exceedingly proud of both Melanie and the work of Praxis.  If you would like to cast your vote to support Melanie and to recognise her achievements with Praxis, please click on the link below. Voting closes on Thursday 12 Feb.

VOTE NOW!

Bellberry’s mission is to protect the welfare of research participants and to improve the quality, efficiency and effectiveness of research.

Whenever possible, we are always striving to make improvements to streamline the HREC process. To kick off in 2020, please find below an update of the significant changes that will impact research sites and sponsors. These changes will be rolling out in the coming days, weeks and months.

If you have any suggestions for future quality improvements initiatives, please email quality@bellberry.com.au.

Sponsor access to eProtocol

Sponsors and CROs wishing to access studies in eProtocol can now liaise with the site Principal Investigator to obtain access.

  • Sponsors can assist with all parts of the application but cannot press ‘submit’. This remains the responsibility of the Principal Investigator.
  • Principal Investigators retain control of all persons that they wish to allow access to.

Read more


Progress reports

Moving to a one-year term of approval cycle from March 2020.

  • Studies approved before March 2020 will remain with current terms and conditions.
  • A protocol violation report must be submitted for any progress report that is submitted after midnight on the date it is due.
  • All sites urged to review their open studies to ensure their progress reporting is up to date.

Read more


Application form

The application form has had some minor question changes.

  • Sites need to be mindful of these changes when applying and read all questions carefully.
  • Declaration of the Principal Investigator has changed.

Read more


Document changes

There are several changes to Bellberry documentation. Many documents that you previously knew as policies are now sitting in an updated structure of Guidance and Resources. Click here for a table of all documents both old and new. This list is not exhaustive; it contains only references to the former policies.

See Guidance and Resources


Site monitoring

From 2020, site monitoring will occur in two ways – face to face and via desktop auditing.

  • Sites will be given a template to complete for desktop audits.

Read more


Institutional responsibilities

By the end of the first quarter of 2020, there will be changes to some documents that Bellberry requests, including site-specific documents.

  • We are currently working with pilot sites & sponsors to test the new process and forms.
  • Sites are encouraged to spend the coming months preparing for how they will manage their internal document flow, version control and authorisation process.
  • These examples relate purely to what documentation is uploaded, and each site is still responsible for creating their own ‘site application’ in the system.

Read more

As we entered 2020 Bellberry celebrated the New Year by reaching our 50th submission for NSW Health Early Phase Clinical Trials.

Bellberry HRECs were appointed by NSW Health for the review of adult Early Phase Clinical Trial (EPCT) applications early in 2019. From April 2019, all EPCT HREC trials conducted at an NSW Public Health Organisation (PHO) site had to be reviewed and approved by an appointed NSW Health EPCT HREC.

Many congratulations to our EPCT team for all their hard work in achieving this milestone!

For further information regarding applications or for submission help please visit the EPCT section of the Bellberry website or contact the Bellberry HREC EPCT Manager Jerneen Williams

The Bellberry office will be closed from Tues 24 Dec at 5 pm until Thurs 2 Jan at 9 am.

There will be no HREC meeting on Wed 1 Jan 2020 (public holiday). The first meeting of 2020 is on Thurs 2 Jan.

All remaining HREC meetings for 2020 will be held weekly every Wednesday.

Due to the recent addition of Early Phase Clinical Trial (EPCT) reviews for NSW public health sites, organic business growth and in preparation for future growth, Bellberry has recently externally advertised and recruited to a number of new roles, several of which have been successfully filled internally.

Member Coordinator

Congratulations to HREC Administrator Molly Wundenburg who has been appointed as Member Coordinator. Molly will work closely with Cathy Stevens liaising with, supporting and co-ordinating over 100 HREC members ensuring that they have all that they need to provide high-quality HREC reviews, along with our ongoing commitment to the recruitment of new members.

IT Operations and Systems Administrator

HREC Administrator Paul Smith will be joining the IT team as IT Operations and Systems Administrator to assist in supporting the businesses key functions including communication, data management, HREC submission and review and data analysis.

Both Molly and Paul have begun transitioning into their new roles and will continue to do so in the New Year.

Team Leaders

Joining Sally Sims, HREC Administrator Margaret Jelbart was successful in obtaining the position of Team Leader.  Margaret commenced the role last month and brings all her previous research and governance experience, as well as a great knowledge of Bellberry processes to the role. Sheree Brozyna has also joined the Team Leader trio. Sheree comes to Bellberry having  worked for a number of years as a forensic scientist. Her research, quality and analytics experience will be a great asset to the team bringing a valuable diversity of experience.

Left to Right – Sheree Brozyna, Sally Sims, Margaret Jelbart

Quality Officer

We are delighted to announce that HREC Administrator Kate Fulton has recently been appointed as our new Quality Officer. After external advertising, Kate was the successful candidate amongst a strong field of applicants. Kate will be joining the Quality team early in the New Year.

Many congratulations to everyone in their new roles!

Due to the recent addition of Early Phase Clinical Trial (EPCT) reviews for NSW public health sites, organic business growth and in preparation for future growth, Bellberry has recently advertised and recruited to a number of new roles including new HREC Officers.

Bellberry is delighted to announce that four new HREC Officers have recently joined the team. Maria Calarco, Dianne Palani-Stahl, Katie Trenorden and Mollie Van Rhoda all joined us in October. They come with a richness of experience including, Research, Medical Reception, HREC Administration and Recruitment. They have already become a great part of our wonderful Admin team and will be allocated their own Committee’s in due course.

Left to right – Maria Calarco, Mollie Van Rhoda, Katie Trenorden and Dianne Palani-Stahl

Due to several internal staff changes as a result of newly created roles (further details to follow), Bellberry now has further vacancies for HREC Officers. Please visit the SEEK website for further information if you or anyone you know may be interested in this role. Closing date for applications is Fri 6 December.

For application details please visit SEEK

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.

The last meeting of 2019 will be held on Wed 18 December with a submission deadline date of Wed 4 December. The first meeting of 2020 will be on Thursday 2 January with a submission deadline of Wed 11 December.

The Bellberry office will be closed from Tues 24 December at 5 pm until Thurs 2 January at 9 am. There will be no HREC meetings on Wed 25 December or Wed 1 January 2020 (public holidays).

Meeting Date     Submission Date

Thurs 2 Jan            Wed 11 Dec
Wed 8 Jan              Wed 18 Dec
Wed 15 Jan            Thurs 2 Jan

Meetings will continue to be held every Wednesday for 2020 with the submission date 2 weeks before the meeting date.