Full member of the Australian Therapeutic Pipeline
Dear members and friends of PTNA
Things are going well at PTNA. Our funding has been extended and Rebecca, our new EO, is now well established. There is also ongoing interest in supporting paediatric trials at a government level. Although the timing and detail of this support are yet to be clarified, PTNA continues to advocate on your behalf.
We are launching several new exciting initiatives. Webspirit is going strong and a new version was successfully rolled out in May. We are also excited to welcome John Hunter Children's Hospital as our newest member. We'll include more about JHCH in our September newsletter.
This edition of the PTNA newsletter highlights some of our recent initiatives including our next scientific meeting, to which you are all welcome. Please mark 14 October 2016 in your diary, we look forward to seeing you there.
Enjoy reading the PTNA newsletter and let us know if you have any feedback.
Best wishes, Prof. Andrew Davidson
PTNA Peer Review
How can PTNA assist?
PTNA offers an impartial and independent review of your new trial concept before you embark on writing your protocol and seeking funding. It is a confidential, fair and timely consideration of your concept. You will be provided with recommendations on how to develop your idea, tackle your challenges, find additional expertise and improve the quality of your trial.
Presentation places are limited so don’t miss out. Registration fees for abstract presenters will be complementary.
Registration for the PTNA Trials Day opens in July and will be available on the PTNA website soon: www.ptna.com.au
WebSpirit User Survey
All WebSpirit users will be invited to participate in the annual satisfaction survey in August 2016.
Please use this opportunity to provide valued feedback on your experiences with WebSpirit. Your feedback will be carefully considered and may lead to future system improvements.
WEBSPIRIT - SPOTLIGHT ON YOUR STUDIES
Metastatic Colorectal Cancer Database:
A prospective observational cohort study examining clinical and molecular biomarkers.
Why did you decide to undertake the CRC Study?
Metastatic colorectal cancer is a common cause of morbidity and mortality in Australia and around the world. However with recent advances in treatment with additional chemotherapy and biologic agents the outlook for patients has improved considerably. Recent research has focused on tailoring treatment to patient’s individual molecular make-up and alterations.
What did the CRC Study aim to do?
The aim of the CRC study is to establish a prospective database of patients with metastatic colorectal cancer.
How do you use WebSpirit?
Tissue samples are collected and tested for known and possible biomarkers and the frequency of molecular alterations. The data is recorded in WebSpirit. In combination with clinical data, this information will assist in refining therapeutic strategies and ultimately improve patient’s outcomes.
What challenges did you face?
In order to meet the aim, data for a substantial number of patients from multiple sites needs to be captured. Funding is limited, a large amount of data is required from three sites across Queensland, at least 900 participants over 10 years are needed; and importantly there needs to be an easy way of reporting the data. There is no funding for on-site monitoring or centralised data entry.
How did WebSpirit help you overcome the challenges?
WebSpirit provides the solution to the challenges. It can be used by each site with limited training, is cost effective, allows centralised data review, provides an audit trail to ensure adherence to ICH-GCP requirements and data can easily be exported.
To monitor trial progress, data needs to be of high quality and easily accessible.
What are the benefits of WebSpirit for the CRC Study?
WebSpirit was specifically developed to capture trial data for investigator-initiated trials from multiple sites. It easily accommodated our trial requirements.Michael, the PTNA Database Manager, continues to provide support and regulatory guidance, including training and controlled, secure access to the database. The application and training are user friendly thereby reducing the time and cost of customising the database. WebSpirit allows data to be easily exported.
How is the CRC Study going now?
The CRC Database began in July 2015. To date over 120 participants from three sites have been entered. An interim review of 88 participants was performed in August 2015.
The PTNA Capability Map goes LIVE!
The PTNA Capability Map data collection has officially begun.
It is currently being rolled out at: Murdoch Childrens Research Institute, Royal Children’s Hospital (Melbourne), Sydney Children Hospital Network including Randwick Children’s Hospital and The Children’s Hospital at Westmead, Children’s Health Queensland, Telethon Kids Institute and Child and Adolescent Health Service (Princess Margaret Hospital).
The PTNA Capability Map will facilitate collaboration by identifying the people and sites who are ready and able to conduct high quality paediatric research.
Please opt-in by including your details in the PTNA Capability Map. The key contacts at the pilot sites are:
Carolyn Stewart – Murdoch Childrens Research Institute and Royal Children’s Hospital
Peng Tjun Choy – Children’s Health Queensland
Nat Eiffler – Telethon Kids Institute
Angela Fonceca - Child and Adolescent Health Service (Princess Margaret Hospital for Children).
Consultations: Medical Research Future Fund Consultation
and 2016 National Translational Health Research Survey
In advocating for paediatric clinical research, PTNA submitted its proposal for the Medical Research Future Fund (MRFF) through the Australian Medical Research and Innovation Strategy and Related Priorities Consultation and the third biennial 2016 National Translational Health Research Survey.
The proposal included a national approach to support paediatric clinical research to maximise opportunities for success. This includes a national child health body focused on clinical research, infrastructure funding, KPIs embedded into hospitals and health services, funding for concept development and extension studies.
The National Translational Health Research survey was undertaken by Therapeutic Innovation Australia to inform the Commonwealth Review of Research Infrastructure. PTNA’s survey response emphasised the need for trials infrastructure, better awareness and interconnectivity between government-funded platforms; and building relationships with industry.
The Kaleidoscope Project
NSW Better Treatment 4 Kids Network
PTNA is proud to support the Kaleidoscope project.
NSW Better Treatment 4 Kids Network is committed to developing a research priority setting project for children and adolescents with chronic conditions. The project, ‘The Kaleidoscope Project', will bring together patients, carers, clinicians and policy makers around Australia to identify and prioritise important research questions. This will help to ensure that those who fund health research are aware of what really matters to both patients and clinicians. The project involves focus group discussions with children and their parents/caregivers, surveys and a one day workshop.
For further information about the project please visit the website: www.thekaleidoscopeproject.com.au. You and your study stakeholders (eg children, parents, carers) can also register to have a say about important research questions and priorities for children with chronic disease through the online survey.
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: firstname.lastname@example.org