In November 2016 the International Council for Harmonisation adopted the second revision to the Good Clinical Practice Guidelines (ICH CGP E6 R2). The changes relate largely to monitoring and related processes and technology. It takes a pragmatic view towards monitoring allowing for a range of approaches. Importantly, it includes an update to Principal Investigators’ responsibilities in terms of oversight.
ICH E6 R2 also provides more guidance on electronic data capture and management for research. WebSpirit procedures and training have been updated accordingly.
While the new version has not been adopted by the TGA yet, it would be advantageous to begin updating your practices for your future trials.
Click here for the ICH slideshow. Click hereto download the ICH GCP guidelines with the new sections integrated (denoted by vertical lines on the left side).
PTNA Concept Development Scheme – open for business!
PTNA is excited to launch its Concept Development Scheme. The Scheme will be 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 - 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...
PTNA Trials Day 2017- Rare Paediatric Diseases
Call for abstracts
PTNA will shortly call for oral presentation abstracts for its annual PTNA Trials Day later this year to be held in Sydney.
This year's theme is Rare Paediatric Diseases
PTNA fosters a respectful and collaborative Trials Day environment in which we can all learn from one another.
Don't miss this opportunity to share your trial concept or your new trial with the paediatric trials community.
Presentation places are limited so don’t miss out. Registration fees for abstract presenters will be complementary.
Registration for the PTNA Trials Day will open in May and will be available on the PTNA website soon: www.ptna.com.
More information will be posted soon.
The Kaleidoscope Project
On 15 October the Kaleidoscope team, led by Professor Jonathan Craig, successfully held its highly anticipated workshop in Sydney.
The workshop was attended by 66 participants from around Australia and 7 national and international facilitators. The workshop brought together children with a chronic condition, parents/caregivers, patient advocacy organisations, researchers, clinicians and policy makers.
The Project is based on the James Lind Approach and consists of a national survey, focus groups and a consensus workshop.
The goals of the workshop were to learn about engaging young people and families in research, understand the different approaches used in Australia and overseas to engage young people and their families in research activities, develop and discuss research priorities in childhood chronic disease, and begin to identify common issues of high importance shared among young people with chronic disease and their families, that should be used to inform a common agenda for trials in Australia. The day was a great opportunity for the participants to mingle and voice their ideas and perspectives with the other stakeholders.
A report will be produced shortly. In the meantime, if you have any questions or want to know more about the Kaleidosope Project contact the Project Co-ordinator, Pamela Lopez Vargas.
The Annual PTNA WebSpirit User Survey was run over January and February this year. The survey was sent to all 176 active WebSpirit users and aimed at gauging how satisfied people were with the system, as well as identifying areas for improvement in future releases of the software.
A huge thank you goes out to all users who participated in this Survey. The time taken to complete the survey was greatly appreciated, and the thoughtfulness and thoroughness of the comments and suggestions was extremely useful and fabulous to see.
We had an almost 50% response rate, with all 20 ongoing studies and most major investigative sites represented.
Satisfaction with WebSpirit remained high, especially in the areas of data entry, ease of use and technical support where satisfaction levels were 92%, 87% and 94% respectively; 88% of users would recommend WebSpirit to others.
Areas where we can improve were identified in the CRF and project management functionalities. We are hoping to address some of these issues by improving our training and education processes, and others through a software upgrade planned for later this year.
The issues raised through the comments sections fell into four main categories:
- Study-specific issues – Allison will be trying to address these with the specific project teams in the coming weeks where possible
- Issues caused by current functionality not being utilised – Allison will be trying to address these issues with specific users over the coming weeks
- Ideas not possible/desirable to pursue – mainly due to technical or GCP reasons
- Ideas for consideration – these will be reviewed by the developers and some will be taken to the Steering Committee for inclusion in future software releases.
As previously, these results will also be used to track changes in WebSpirit usage and satisfaction into the future. We thank you all again for your contribution.
WEBSPIRIT - SPOTLIGHT ON YOUR STUDIES
The ZAP Study
What’s the name of your study?
ZAP Study: Bisphosphonate Treatment of Childhood Femoral Head Avascular Necrosis due to Perthes Disease.
What does the study aim to do?
The ZAP Study is a multi-centre, prospective, randomised controlled trial. It is a two year study aiming to determine if 12 months of intravenous Zoledronic acid improves femoral head sphericity. The study investigates whether there are improvements in hip function and pain, as well as the effects on quality of life in children aged between 5 and 16 with Femoral Head Avascular Necrosis due to Perthes Disease.
The ZAP Study is an NHMRC Investigator-driven study, conducted on a national basis. Sydney Children’s Hospitals Network is the lead site and collaborating sites are The Royal Children’s Hospital in Melbourne, Lady Cilento Children’s Hospital in Brisbane, Women’s and Children’s Hospital in Adelaide, Princess Margaret Hospital in Perth and an additional site in Auckland NZ.
What challenges did you face?
Finding a database that could be specifically framed for our study
Training for data entry, project managers, monitors and investigators across multiple sites
Collection of data from multiple sites
Monitoring of data entry, including Investigator sign-off from multiple sites
Reporting data for analysis
Managing the protocol guidelines
Providing information and documentation across multiple sites
Support in using and accessing WebSpirit
How did WebSpirit help you overcome the challenges?
WebSpirit enabled the unique aspects of the study protocol to be developed in the database, rather than using a cumbersome and risky excel spreadsheet
Training materials for all levels of personnel that have access to the database for our study is available through several outlets such as via the WebSpirit site or directly from the PTNA Database Manager. Training has been available on an ongoing basis and has included updates on WebSpirit improvements and upgrades.
All personnel are trained before appropriate access is given, prior to data entry.
WebSpirit has enabled data to be captured in a clear and secure manner from the lead and collaborating sites.
WebSpirit is able to show our study progress, each participant’s status and data entered in a logical manner. It uses well defined tables to view and access each section of the study visit and the protocol requirements.
WebSpirit enables the user to monitor and validate information. We have been able to see the flow of queries raised and answered throughout the database over the duration of the study.
WebSpirit has the capability to export reports in various forms, such as graphs and excel spreadsheets (if required), to assist in analysing the study data and study progress
Initially, all information and results were placed in an excel spreadsheet but now we have WebSpirit. This is a great improvement.
What are the benefits of WebSpirit for the ZAP Study?
Training, access and professional support has been premium. It has assisted the ZAP Study team to conduct and capture the required primary and secondary end-points over a two year period.
Support has always been available promptly from the WebSpirit experts at PTNA who have assisted us, across Australia, with any concerns throughout the study.
WebSpirit meets the requirements of a clinical research trial, within an acceptable budget. It has and will allow us to validate and analyse secure and complete data. In addition, the ability to present this information in a professional manner to other research personnel and organisations clearly shows the benefits of investing in the WebSpirit database.
WebSpirit has allowed us to capture and make available additional information that will enable possible future research into Perthes disease or similar conditions.
How is the ZAP Study going now?
All recruitment has now ceased, with a total of 85 consented participants, of which 3 have withdrawn. 27 participants are still completing their two years on study, with the last participant to finish in August 2018.
National Research Infrastructure Roadmap consultation
PTNA submitted a response to the Draft 2016 National Research Infrastructure Roadmap in January. Its main focus was on ensuring that paediatric clinical research infrastructure is not overlooked by both the updated Roadmap and the Medical Research Future Fund.
There has been no further correspondence regarding the Roadmap but a final version is expected to be released soon.
APREG: Australian Paediatric Research Ethics and Governance network
The recently developed APREG Guide to Consent Involving Young People in Clinical Trials was endorsed by the PTNA Steering Committee and is currently being put forward to each HREC for consideration and endorsement so that it may be finalised and publicised in May. Keep an eye out on the PTNA website.
The next project the group will undertake is guidelines on involving children and young people in research when they are under an assumption of care. Guardianship laws differ across Australia and the APREG guidance will provide further clarity to investigators and sponsors.
In addition, once the data from the Good Clinical Practice Pilot of Site Authorisations is compiled by the NHMRC, stratification will be done on the paediatric studies. APREG will use this data to benchmark and develop processes and guidance that can improve ethics and governance approval times.
PTNA Clinical Research Managers’ Committee
The PTNA CRM Committee met in March. The Committee is directly addressing PTNA’s objective to improve the operating environment for paediatric trials in Australia for investigator initiated and commercial studies. Its current focus is on costing.
A baseline investigation is underway into the current practices across the participating PTNA members in order to determine how to streamline costing and budgeting activities.
Please contact us or your PTNA Steering Committee member [link] if you are a manager of a clinical trial department at a PTNA member site and would like to participate in the CRM Committee.
Health economics for trials PTNA has teamed up with the Centre for Health Policy at The University of Melbourne to bring you access to health economics experts to assist with your paediatric clinical trials. The Centre can also link you to a local health economics group if you wish.
The Centre is also offering discounts to PTNA members on their health economics courses held throughout the year in Melbourne. All you need to do is contact PTNA [link to info email address] to make the booking.
In addition, health economics will be one of the services offered through the PTNA Concept Development Scheme.