The ACTA Statistics in Trials Special Interest Group (STInG) is a group that promotes the practice and recognition of the importance of statistics within clinical trials and provides a forum to improve the statistical quality of investigator-initiated clinical trials within Australia through enhanced collaboration and networking among trial statisticians.
Francesca Orsini
Francesca Orsini is a senior biostatistician at the Murdoch Children’s Research Institute and has been a member of STInG since its inception in 2016. The BRACE trial,
for which Francesca is the lead statistician, recently
won the ACTA STInG Excellence in Trial Statistics award.
Tell us about your current role and career to date
I graduated in Milan, Italy with a Master of Science in Biostatistics and Experimental Statistics. My career began as a biostatistician and research assistant at a small university, followed by a role at a Contract Research Organization (CRO), where I was introduced to clinical trials. In 2011, I migrated to Australia and joined the Murdoch Children’s Research Institute (MCRI) in the Clinical Epidemiology and Biostatistics Unit (CEBU). I am currently a senior biostatistician, and am deeply involved in clinical trials from the grant writing stage, to developing study protocols, conducting statistical analyses, and contributing to publications.
How did you first get involved with ACTA STInG, and what motivated you to join?
I became involved with ACTA STInG after being tapped on the shoulder by my supervisor and co-chair of STInG, Katherine Lee. I saw the value in connecting with other high-quality biostatisticians outside of CEBU, something that would be particularly valuable for those statisticians that may not have access to a larger network. The opportunity to make connections and share problems was a significant motivator for me to join.
How has being part of the ACTA STInG influenced or benefited your work?
ACTA delivers valuable webinars and workshops that cover both practical topics and emerging concepts, especially in adaptive trial designs, which are becoming increasingly popular. The resources available on the ACTA website are helpful, and I have used resources beyond statistics, for example the grant application resources to help securing funding. I also find the Data Safety Monitoring Board (DSMB) and the DSMB directory very beneficial.
Tell us your experience winning the ACTA STInG Excellence in Trial Statistics award.
Statisticians often work behind the scenes and rarely receive recognition for their contributions, so this award was particularly meaningful to me. It validated the effort and countless hours and sleepless nights I invested in one of the most challenging trials I’ve participated in, and it boosted my confidence. TOTY provides recognition not only in front of peers, but showcases to the sector the importance of involving a statistician from the very beginning of the trial. I have also been invited to speak at the upcoming ACTA 2024 Clinical Trials and Registries Symposium, which provides another opportunity to showcase the importance of high-quality statistics in trials.
What do you see as the future directions for statistics in trials in Australia, and how is ACTA STInG positioning itself to address these?
The future of statistics in trials in Australia is increasingly moving towards more innovative and flexible methodologies, with adaptive design trials at the forefront. Adaptive trials allow for modifications to the trial procedures (such as sample size or treatment arms) based on interim data, which can lead to more efficient, faster, and potentially more informative results without compromising the integrity of the study.
ACTA STInG is well-positioned to support this evolution, fostering collaboration between trial statisticians across Australia, focusing on
enhancing expertise in adaptive designs, as well as other advanced methodologies like Bayesian approaches and platform trials.
Through ongoing training, mentorship, and networking opportunities, ACTA STInG can help build a strong foundation for these methods to become standard practice, ensuring that Australian clinical trials remain at the cutting edge of global research.
What advice would you give to other statisticians or researchers looking to leverage groups like ACTA STInG?
Connecting with other statisticians and peers, particularly if you work autonomously, is invaluable. Go to meetings, webinars,
symposium and make connections, as you do not need to be alone. My experience on the BRACE trial is a great example: it was the start
of the pandemic, things were moving so quickly, and we were confronted with new challenges that were never encountered before. Thanks to ACTA STInG we were able to reach out to other experts to discuss and troubleshoot together.
ACTA TRIAL OF THE YEAR AWARDS
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 is a category that
highlights the quality of statistical design. Evaluated by an expert panel of senior biostatisticians, the focus is
on rigorous methodologies, robust statistical plans, and clear interpretation of results.
Resource Documents
Winner of the ACTA STInG Excellence in Trial Statistics award shares how ACTA STInG provided valuable networking opportunities during the pandemic
