| 2nd May 2025 |
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| Improving child health through research |
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| PTNA Trials Day 2017- Rare Paediatric DiseasesJoin us on 30 August 2017! Paediatric Trials Network Australia will bring together experts in rare childhood diseases and in rare treatments for diseases from all over Australia for the PTNA Trials Day. With a focus on clinical trials this full day event will be jam-packed with presentations including topics such as:Cannabinoid studies in intractable epilepsyUmbrellas, baskets and platforms: brave new world of trail design for rare and not-so-rare diseasesTrials of novel treatments in developmental disorders: methodological challenges and outcome assessmentEmerging treatments in spinal muscular atrophy Statistical principles for clinical trials The role of genomics and the role of proteomics in rare diseasesResearchers, study co-ordinators, research nurses students and other health and research professionals who are interested in rare diseases are encouraged to register now. Date: 30 August 2017 Cost: $100 medical professionals, $75 non-medical professionals Location: The Bright Alliance, Randwick NSW. More information and to register click HERE.PTNA Concept Development Scheme – open for business!  Do you have a research question that you’d like to develop into a clinical trial? The PTNA Concept Development Scheme is open all year round and only takes about 8 weeks from submission to final recommendation. The Concept Development Scheme aims to help turn your high quality trial ideas into reality by providing expert advice to further develop your concept. As part of the Scheme PTNA can also offer small grants for services to improve your concept. Services may include assistance with biostatistics, health economics or study design. In addition, you will:- be provided with a recommendation letter that can be used for your grant application- be eligible for additional WebSpirit (electronic data management software) discounts- gain access to PTNA’s network of clinical research infrastructure across Australia including recruitment sites, local investigators and experts in a variety of sub-specialties- be able to utilise the streamlined ethics and governance review through APREG ; and- be given the opportunity to present your concept to the paediatric clinical research community at the annual PTNA Trials Day.Read more …Complete the template for confidential review and development by PTNA and submit it to info@ptna.com.au  ACTA’s Economic evaluation of investigator-initiated clinical trials conducted by networks released!The Australian Commission on Safety and Quality in Health Care commissioned report undertaken by the Australian Clinical Trials Alliance (ACTA) shows about a 6:1 return on investment for clinical trials in Australia.This report is the first of its kind to evaluate the impact of each dollar spent on investigator-initiated clinical trials. Three trials networked provided the data for the study: the Australasian Stroke Trials Network (ASTN), Interdisciplinary Maternal Perinatal Australasian Collaborative Trials (IMPACT) Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG). Read the full report: https://www.safetyandquality.gov.au/publications/economic-evaluation-of-investigator-initiated-clinical-trials-conducted-by-networks/Handy e-protocol tool developed by the National Institute of Health (US)The protocol is FDA compliant and free. It allows you to collaborate with multiple authors while you write your protocol and track its progress within the portal, then export it. https://e-protocol.od.nih.gov/#/home WEBSPIRIT – SPOTLIGHT ON YOUR STUDIES  .The HUNTER Study What’s the name of your study?The HUNTER study: High-flow nasal cannulae use in non-tertiary centres for early respiratory distress in newborn infantsWhat does the study aim to do? The HUNTER study is an NHMRC-funded trial comparing two methods of providing respiratory support to newborn infants. We plan to randomise 750 infants in nine Australian hospitals in New South Wales and Victoria; recruitment is currently about six months ahead of schedule, and we expect to complete randomisation in early 2018. What challenges did you face? We were fortunate to receive support through a NHMRC project grant, but resources are always limited. The large sample size and number of hospitals represents a significant logistical challenge.We did not have budget to develop and run an internet-accessible multi-user database. Our internal skillset would have allowed us to develop a stand-alone MS Access database, but this would have required transfer of huge volumes of paper (more than ten multi-page forms for a significant number of babies), and would have led to huge numbers of phone calls to clarify data queries. How did WebSpirit help you overcome the challenges? WebSpirit allowed us to locate data-entry within each hospital, with data monitors located in each state, only occasionally visiting hospitals to provide training and support. In addition to the risks of moving large amounts of paper to a central location, this also saved us a lot of money in travel, and is likely to have improved the quality of the data. What are the benefits of WebSpirit for the HUNTER Study? Database programming in WebSpirit is relatively easy, because of the extensive in-built functionality, but the system is novel, so support was required from the WebSpirit Database Managers. Ongoing advice is also needed as we discover new requirements, and new problems emerge. A key element of the success of the program has been the quality of the support we have received; help and advice is always prompt. The commitment to service is institutionalised, as demonstrated in the hiring decisions made, and in the support provided when we were between PTNA Database Managers. Not only has our efficiency been improved, but the internal messaging and data query/response system is vastly better than any system we could have devised. How is the HUNTER Study going now?We have been able to manage, with limited resources, a large clinical trial in nine hospitals. Moreover, we have been able to cope with a recruitment rate about 20% higher than we anticipated. WebSpirit has become essential infrastructure for the efficient and accurate conduct of paediatric clinical trials in Australia.WebSpirit – New FunctionalityWe have recently had 2 functionalities added to WebSpirit:RandomisationThe ability to move studies between the TEST and LIVE environments.What this means for WebSpirit users:Randomisation: Randomisation can now be set-up within WebSpirit, with our first study to utilise this functionality about to go LIVE. If you are interested in using this in an upcoming study please don’t hesitate to get in touch. We can work with your statistician to design a randomisation schedule that will work in WebSpirit, and allow randomisation and data entry to happen within the single system.Migration of studies between TEST and LIVE environments: When creating a new study or making substantial changes to an existing study, we would encourage that all changes and development work be carried out in the TEST environment. Once all development work is finished and tested, we can simply migrate your changes across to the LIVE environment – this not only increases your ability to test any changes made, but also prevents any impact on those entering data. If this is something you need to do, please let us know so we can make the TEST system available to you and ensure that the current version of your study has been moved to the TEST system for you to work on.Thinking of using WebSpirit for your next study? Contact Allison van Lint on webspirit@ptna.com.au or 03 9936 6443 NHMRC’s new Clinical Trial and Cohort Studies SchemeIn 2016 the NHMRC consulted widely on the restructure of the review of its grant program. Anne Kelso, NHMRC CEO, announced the new structure was by in February 2017. Read about the new structure here: https://www.nhmrc.gov.au/restructure As part of the restructure the process for applying for and reviewing clinical trials and cohort studies were excised from the general program in favour of a new scheme. The reasoning behind the different treatment for these types of applications is to remove the capping of studies for investigators on trials. Due to the collaborative nature of clinical trials investigators need the freedom to contribute to numerous studies. For example a biostatistician need not be concerned with capped grants when contributing to multiple studies. A public consultation on the framework for NHMRC assessment and funding of clinical trials and cohort studies occurred in June and July this year (read more here: https://consultations.nhmrc.gov.au/public_consultations/clinical-trials-cohort-studies). PTNA submitted a response and is keen to hear about the framework’s progress. PTNA will keep you informed.National Research Infrastructure Roadmap consultationThe final 2016 National Research Infrastructure Roadmap was released in May this year. There are nine areas of focus identified:Digital Data and eResearch PlatformsPlatforms for Humanities, Arts and Social SciencesCharacterisationAdvanced Fabrication and ManufacturingAdvanced Physics and AstronomyEarth and Environmental SystemsBiosecurityComplex BiologyTherapeutic DevelopmentThe Roadmap indicates the government priorities for the coming decade and as a corollary, where funding will be directed. Find the full report here: https://www.education.gov.au/2016-national-research-infrastructure-roadmapMedical Research Future Fund In May the federal government announced its first disbursement from the Medical Research Future Fund. The funding is in addition to the $800+ million disbursed by the NMRCH for health and medical research. The six priorities for 2016-18 are:Strategic and international horizonsData and infrastructureHealth services and systemsCapacity and collaborationTrials and translationCommercialisationThe total amount disbursed in the first year 2016-17, was $65.9 million of which clinical trials received approximately $33 million for programs such as:$13 million to stimulate clinical trial and registry activity to improve patient outcomes, health system efficiency and drive innovation.$5 million over four years (from 2016-17) for a national alliance partner to build the capacity of existing and new Clinical Trials Networks (CTNs).$8 million to ensure the supply of high quality next generation research talent through boosting the scale of existing National Health and Medical Research Council (NHMRC) fellowship schemes.$7 million to create a better collaboration, the Turnbull Government is also providing over four years to help redesign State and Territory clinical trial operating systems.In addition, $5 million will fund CanTeen to undertake clinical trials in adolescents and young adults. We congratulate ACTA on successfully achieving $5 million over four years and thank Rhiannon Tate the outgoing CEO of ACTA for all of her hard work in getting ACTA to this point. Read more about MRFF disbursements here: www.health.gov.au/internet/main/publishing.nsf/Content/medical-research-future-fund-budget-2017-factsheets PTNA Clinical Research Managers’ Committee The CRM Committee met in June. The main focus of the meeting was to discuss collective position statements related to costing of trials. These will be placed on the PTNA website once refined; and reviewed and approved by the PTNA Steering Committee Keep an eye out on the PTNA website.APREG: Australian Paediatric Research Ethics and Governance networkAPREG has released its long awaited Clinical trials, the child participant and consent: a practical guide for investigators and sponsors. The group has worked on the guidelines for over a year and it has the tick of approval from the PTNA Steering Committee and participating hospital’s executives. The guide answers questions that you might ask or sponsors of trials might ask, like:Are assent forms required in Australia?What if a parent and child’s view regarding participation in the clinical trial conflict?Can investigators request exemption from parental consent?Who signs the informed consent form when a child’s parents are separated?Should the written information provided to the child participant differ from the written information provided to the parent(s)/legal guardian(s)?Who should provide written informed consent to participate in a paediatric clinical trial?Access the practical guide here.Upcoming events  2017 PTNA Trials Day (Sydney) – 30 August –Register hereAcute Care Research and Translation Symposium and Workshop (Brisbane) 24 & 25 August – read more2017 ARCS Australia Annual Conference – (Sydney) 22 – 24 August – read moreNot 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: info@ptna.com.auPTNA Steering Committee:NSWProf Chris CowellThe Children’s Hospital at Westmead, Sydney Children’s Hospitals NetworkNSWProf Jonathan CraigThe Children’s Hospital at Westmead, Sydney Children’s Hospitals Network, University of SydneyNSWProf Ian WrightIllawarra Health and Medical Research InstituteNSWDr Koert de WaalJohn Hunter Children’s Hospital, Hunter Medical Research Institute, University of NewcastleVICProf Andrew Davidson (Chair)Murdoch Children’s Research Institute, The Royal Children’s HospitalVICProf John CarlinMurdoch Children’s Research Institute, University of MelbourneVICProf Jim ButteryMonash Children’s Hospital, Monash HealthNTProf Peter MorrisRoyal Darwin Hospital; Child Health Division, Menzies School of Health ResearchSAProf Helen MarshallWomen’s and Children’s Hospital, AdelaideQLDTo be advisedChildren’s Health Queensland Hospital and Health ServiceWAProf Peter RichmondTelethon Kids Institute, Child and Adolescent Health Service |
