Dear STInG members,

Welcome to our STInG newsletter! We’d like to share with you the exciting initiatives we have been working on in 2024. It is an exhilarating time for clinical trialists and statisticians working in trials, with lots of enthusiasm about innovative trial designs of various forms, with “platform trials” being the new buzzword. These innovative designs bring not only great opportunities for clinical trial statisticians, but also challenges in their design and implementation. You can read more below about the various initiatives we have been working on in this area.

Come and join us at the annual ACTA Clinical Trials and Registries Symposium in Melbourne on December 2-4 to hear more about these novel designs, where we will also be hosting our annual STInG members breakfast meeting on December 3 at 7:15am at the Pullman, Albert Park. Within this newsletter we have also included an update on our Trial of the Year Excellence in Statistics award winner, our ongoing DSMB mentoring scheme, our STInG Chat plans, and the various resources we have set up to hopefully assist you in navigating life as a clinical trials statistician.

We hope you will enjoy the updates in this newsletter, and we hope to see you at our members meeting, either in person or on Zoom.

Best wishes,
Kate and Andrew
Co-chairs, ACTA STInG

ACTA STInG Excellence in Trial Statistics Award

In May this year, we were pleased to announce that Francesca Orsini, a STInG member based at the Murdoch Children’s Research Institute (Melbourne), and the statistical team on the BRACE trial (published in the NEJM) have been awarded the ACTA STInG Excellence in Trial Statistics Award. This important global study explored the potential of the BCG vaccine to offer protection against COVID-19 for healthcare workers during a critical time early in the pandemic. Involving nearly 7,000 participants across 36 hospitals in five countries, it stands as one of the largest studies conducted during the crisis. The BRACE trial was complimented for its transparency around changes to the trial design and statistical plan in response to emerging patterns of the COVID pandemic. In addition, the trial included a sophisticated method for the analysis of their primary outcome using weighted flexible parametric survival curves. In accepting the award at the annual Trial of the Tear Award presentation ceremony Francesca acknowledged the invaluable help and contributions of her colleagues, Cecilia Moore and Kate Lee, whose expertise and support were instrumental in the success of this study.

Francesca will be presenting about the statistical journey of the BRACE trial at the ACTA 2024 Clinical Trials and Registries Symposium.

Elaine Pascoe from the Australasian Kidney Trials Network, University of Queensland was recognised the runner-up her exceptional work on the BEST-Fluids trial (published in The Lancet). This was an investigator-initiated, pragmatic, registry-based, multi-centre, double-blind, randomised controlled trial evaluating the effect of Plasmalyte versus 0.9 % saline on early kidney transplant function in deceased donor kidney transplantation. The BEST-Fluids trial was applauded for its broad consistency throughout the design, conduct, and analysis.

From left to right: Chris Reid (ACTA chair), Jean-Frederic Levesque (Deputy Secretary for the new Clinical Innovation and Research division of the NSW Ministry of Health), Andrew Davidson (Director, Melbourne Children's Trial Centre) and Francesca Orsini (lead statistician) accepting the STInG Excellence in Trial Statistics award for the BRACE trial.

The ACTA Trial of the Year awards celebrate excellence in clinical research, recognising outstanding trials that push the boundaries of scientific inquiry. The ACTA STInG Excellence in Trial Statistics Award highlights the quality of statistical design, methodologies, conduct of the statistical plans, and interpretation of results. It is a fantastic way for trial statisticians to get recognition for their hard work and critical input, and we highly encourage you to consider submitting an application for this award early next year. Keep an eye on the ACTA newsletter for details to come.

Join us at the annual STInG members meeting on 3rd December for a presentation about the process of the STInG Excellence in Trial Statistics Award and some insight into what the judges of the award are looking for in applications. More details in upcoming events below.

Recent STInG initiatives

DSMB Mentoring Program Update

The ACTA STInG Data and Safety Monitoring Board (DSMB) Mentoring Program for Statisticians is in its third year and is continuing to be a valuable and successful initiative. This program pairs experienced mentors with statisticians (mentees) who are looking to develop their skills in the role of DSMB statisticians. Mentees gain practical experience and insights into data safety and ethical oversight in clinical trials with the aim of being able to take on DSMB roles following the program. With a new cohort of mentors and mentees, we anticipate continued growth and learning in this important area, expanding the pool of statisticians able to participate in this important aspect of clinical trial conduct.

Feedback from participants includes:
“A very good insight into the overall process of a DSMB.”
“The mentor has provided excellent background advice and knowledge for the DSMB that we both attended. Will be continuing the mentor-mentee arrangements for a few more forthcoming DSMB meetings.”
“Great initiative”
“I have been asked to serve as a statistician on a DSMB. The trial starts next year. Our meetings gave me the confidence to say yes so thank you again :)”

For more information or to express your interest in joining the program, please click here.

STInG Progress Report

Membership Numbers
ACTA STInG is ever expanding, and currently has 176 members from over 80 institutions in Australia. With 15 engaged members on the Executive Committee, STInG continues to strive to promote the practice and recognition of the importance of statistics within clinical trials, and provide a forum to improve the statistical quality of investigator-initiated clinical trials within Australia through enhanced collaboration and networking among trial statisticians.

Expanding the Remit to include Registries
STInG has extended its remit to include registry statisticians and data analysts, broadening our community to support this vital area of research. We recognise the unique challenges and contributions of registry statisticians, and we want you to feel welcomed and supported within our network. We encourage you to share this news within your professional circles and invite all registry statisticians and data analysts to join STInG, where we can work together to foster collaboration and strengthen the impact of our work.

Upcoming Events

STInG Annual Members Meeting
Our annual STInG members breakfast meeting is coming up on Tuesday 3^rd of December, at 7:15am at the Pullman, Albert Park. Please join us for this valuable opportunity to meet and network with peers, while providing input on future STInG initiatives and direction. Join us for engaging discussions on relevant topics, including a presentation on tips for the STInG Excellence in Trial Statistics Award. We look forward to seeing you there!
Please note, while we would love to meet you in person, you can attend the breakfast meeting virtually. Please RSVP by 15 November to sting@acta.au.
We invite all STInG members to submit agenda items and discussion topics for our upcoming meeting — please share your suggestions by 15 November.
 
ACTA Symposium Presentations and Workshops
The ACTA 2024 Clinical Trials and Registries Symposium will be held from the 2-4^th of December in Melbourne and has an exciting line up of both national and international speakers. The symposium is a great opportunity to network with other STInG members as well as the broader ACTA community. It will also feature a number of workshops relevant to STInG members that will help hone skills in areas such as cluster trials, platform trials, and data safety monitoring board. Visit https://acta2024.com.au/acta-workshops for more information.

Coming up in 2025:
An overview of the design and conduct of registry-based trials, with Professor Arul Earnest from Monash University.
If you have any ideas for topics for the STInG-chat or webinars that would be of interest to the STInG community, please email us at: sting@acta.au.

Resources and Links

The STInG Discussion Forum is a valuable resource where you can post your questions and challenges, receive input from fellow statisticians, and enhance your networking and support. To post your discussion, simply email acta-sting@gaggle.email
As an ACTA STInG member, you also have access to the Find a Statistician Database, which enables you to search for and connect with other statisticians who have expertise in specific areas, facilitating support and collaboration on your research projects.
This also features a DSMB directory that gives you access to a list of potential statisticians to serve on the DSMBs for your trials .

We want to hear from you! If you have a minute or two spare, we would appreciate your feedback via this quick survey.
 
For administrative support or if you have any questions relating to STInG, please contact us via sting@acta.au