In addition, the Steering Committee are delighted to welcome three new committee members:
Dr Koert deWaal for John Hunter Children’s Hospital;
Professor Jim Buttery for Monash Children’s Hospital; and
Dr Robyn Littlewood for Children’s Health Queensland Hospital and Health Service.
We bid a fond farewell to Professor Ross Pinkerton who has been a great supporter of PTNA since its inception. His expertise and thoughtful contribution will be missed. We wish Ross all the best in his role at Hummingbird House.
PTNA Trials Day - Postponed
The 2016 PTNA Trials Day was unavoidably postponed to 2017.
PTNA wishes to thank all of the speakers who were enthusiastic about presenting to an engaged paediatric research audience. PTNA also wishes to sincerely apologise to those who had registered and those who had submitted abstracts for oral presentations.
Please keep an eye out for the return of the PTNA Trials Day in 2017.
PTNA Capability Map
The Capability Map is underway and we’re starting with expertise.
The survey is simple and only takes 5 minutes. CLICK HERE.
We have been busily populating our database of paediatric clinical research experts from across Australia. The database will be used to:
identify and inform you about new commercial trials and investigator-initiated trials;
facilitate collaboration across the leading paediatric research sites in Australia;
broaden your recruitment pool;
facilitate international collaborations;
offer you the opportunity to participate in the development of new research ideas;
disseminate trial news;
consult your opinion on important decisions in your field.
PTNA will not use your information for purposes other than paediatric clinical research. Your data will be held confidentially and securely by PTNA and will not be given to third parties without your consent. PTNA will also provide your data back to your employing organisation. You can opt-out at any time.
PTNA has successfully secured funding for another year from the federal government’s National Collaborative Research Infrastructure Strategy (NCRIS) Translating Health Discovery (THD) Project. The THD Project is managed and administered by Therapeutic Innovation Australia. We thank both TIA and the Commonwealth Government for this generous contribution towards paediatric trials infrastructure.
Medical Research Future Fund Consultation –
Paediatric Clinical Trials recognised!
A public forum was held in each state throughout July and August for the federal government’s Medical Research Future Fund (MRFF) consultation following written submissions earlier in the year. The Fund was established under the Medical Research Future Fund Act 2015. The Advisory Board invited submissions on research ‘Strategy’ and/or a research ‘Priority’.
PTNA was pleased to see that paediatric clinical trials had been explicitly listed as a recognised gap in the proposed matrix that will inform the new strategy. In addition, clinical trial networks and data registries were clearly highlighted thanks to ACTA’s and clinical trial networks’ submissions.
PTNA’s ‘Strategy’ and ‘Priority’ proposals to the MRFF included a national approach to support paediatric clinical research to maximise opportunities for success. While the MRFF Advisory Board has recognised this important initiative, our role is not over. With your support, PTNA will continue to lobby for better infrastructure and opportunities to undertake high-quality research to develop evidence-based care for children.
Structural review of NHMRC’s grant program consultation
In August and September PTNA members attended the public NHMRC grant program consultations held in each state to ensure that paediatric clinical research was well represented. The consultation paper presented three models on which comments were invited. The models were intended to invoke robust discussion within the research community and high-quality responses to the Expert Advisory Group.
In late August, PTNA’s Expert Advisory Group made a paper submission to the consultation. While PTNA found merit in each of the three models, its fundamental message was in relation to the overall distribution of the Medical Research Endowment Fund such as streamlining the number of schemes, the fellowship programs and improving the quanta of large grants to make up for the loss of smaller grants. In addition it was recognised that the proposed models did not meet the needs of clinical or epidemiological research. PTNA advised that at least two of the models could apply to these types of research with some tweaking.
Declaration: Professor Jonathan Craig is a member of the Expert Advisory Group. He did not contribute to the PTNA submission to the structural review.
National Research Infrastructure Roadmap Consultation
The last public consultation to occur simultaneously with the two above was the Commonwealth’s National Research Infrastructure Roadmap. A capability issues paper was released in July. It outlined the current focus and the proposed changes.
PTNA’s main concern with the Roadmap is that clinical trials is not recognised as a field of research. The Roadmap does however recognise the importance of clinical trials as a means of translation across many other health and medical science disciplines. In particular, PTNA made advised that without sustainable infrastructure for paediatric clinical research, Australia will not be able to meet the needs of Australians or keep up with international progress in this area. There is also a very real risk of losing the skilled and qualified paediatric research workforce. With targeted investment in paediatric clinical research, PTNA will be able develop local research and researchers and also partner with international counterparts who are working toward improving health for children. PTNA suggested the inclusion of paediatric clinical trial infrastructure as an ‘emerging trend’.
The newly formed PTNA Paediatric Clinical Research Managers’ Committee is part of PTNA’s focus on improving the paediatric clinical trials landscape in Australia. The members have operational responsibilities for clinical research across Australia’s leading children’s health services.
The Committee will focus on sharing procedures, documentation and knowledge and will provide advice to the PTNA Steering Committee.
WEBSPIRIT - SPOTLIGHT ON YOUR STUDIES
A phase 1 cancer trial
What’s the name of your study?: ECREST: A Phase 1 study of intravenous EEDVSMit in children with recurrent/refractory solid tumours or central nervous system tumours expressing epidermal growth factor receptor.
What does the study aim to do?
The primary outcomes are to determine a recommended dose for the phase 2 study to follow; to define and describe the toxicities of the investigational product and to assess its safety and tolerability.
What challenges did you face?
It was very important for the study to use a database which is auditable and gives access to site data as soon as possible, particularly because it is a multi-site study. The database selected needed to address the following issues:
Rapidity: The central study team needs data from all sites on the study as soon as possible to determine the next dose assignment for each recruited patient.
Safety: Safety is extremely important in any clinical trial, but particularly for early phase trials where you are establishing a safety profile for the product.
Monitoring: Due to the high risk nature of this study the monitoring requirements are extensive.
Versatility: Medical oncology clinical trials have unique and extensive data collection. We needed a versatile database to design a CRF for efficient collection of data from the sites.
Security: This trial will be running for a long period of time which requires a secure database and support for the entire length of the study.
How did WebSpirit help you overcome the challenges?
WebSpirit allows for the reporting of adverse events to be immediate. The central management team can see all adverse events as soon as they are entered by each site. This information is then used to determine the dose level for the next recruited patient. There are also strict requirements for the sponsor to report serious adverse events to Governance and the regulatory authority (Therapeutics Goods Administration). WebSpirit helps us to identify safety issues quickly.
What are the benefits of WebSpirit for the ECREST Study?
WebSpirit allows for an audit trail and queries to be raised by the monitor within the system. It enables an efficient monitoring system which is essential for high risk trials.
WebSpirit is a very user-friendly system and has a lot of features useful for CRF design, such as table format and drop-down selection fields, unique patient identifiers, and flexible visit planning. Each stage of the process, from CRF design to data entry, monitoring and data export, is clear and has excellent training material provided.
I have received ongoing support from the PTNA Database Manager since early 2015. During this time improvements have been made to the entire WebSpirit system in such a way as to not impact on the individual study. I am confident I will get the support required for the entire length of the study.
How is the ECREST Study going now?
The WebSpirit database created for the ECREST study has now been used by site staff and is quick and easy to learn and use. Changes, of which there has not been many, are easy to make. Seventeen patients have been pre-screened and three are enrolled. Data for all patients has been successfully entered. Adverse events for each patient are clearly reported.
The study is due for completion in 2021.
'I would recommend WebSpirit to anyone regardless of the type of trial they are running. It is extremely versatile and has many features useful for many types of research.'
Ann Gould, ECREST Project Manager
Your questions answered...
What is WebSpsirit?
WebSpirit is a cost-effective solution to clinical research data capture and file management. It is a custom-built web-based data management system accessible from anywhere in the world where the internet is available.
Who can use it?
It is suitable for all types of clinical research projects: trials, non-trials, paediatric and adult.
PTNA member sites receive discounts on fees. Non-PTNA members, networks, industry partners and individual researchers in Australia and New Zealand are welcome to use WebSpirit. It is ideal for single-site or multi-site research.
Where is the data held? Do I need space on my organisation’s network?
WebSpirit is installed on a firewall protected server in Sydney with data backups daily. There is no need to take up precious organisational network space. WebSpirit can also act as your study’s central document repository from which you can share up to date research documentation and control versions.
WebSpirit Management Changes
We farewelled Michael Emamooden, the WebSpirit Database Manager, in July as he moved on to new horizons. In Michael’s capable hands WebSpirit has grown to include thousands of participants and happy project teams. It is now the preferred data capture system for many clinical trials, registries and other clinical research.
We wish Michael every success in his new role as the Clinical Systems Manager at Sirtex Medical.
PTNA has taken this opportunity to relocate the WebSpirit Database Manager role to Melbourne. It will be hosted by Luke Stevens’ data management team in the Clinical Epidemiology & Biostatistics Unit at the Murdoch Childrens Research Institute.
In light of these changes the WebSpirit user survey that was due to occur in August will be delayed.
Not a member of PTNA Yet?
PTNA is an inclusive network of organisations that undertake high quality paediatric clinical trials.
Large site = $4,000 per annum. Small site = $1,000 per annum.
Talk to us about the benefits of membership and being actively involved in the paediatric trials community: email@example.com