1 Recent Initiatives
1.1 DSMB mentoring scheme
The second round of the Data and Safety Monitoring Board (DSMB) mentoring scheme has recently kicked off, with 9 pairs of mentors and mentees who have started the program. The mentoring program aims to address the shortage of statisticians who can serve on DSMBs by providing ‘on-the-job’ training for statisticians. The model for the program revolves around meetings for one or more DSMBs on which the mentor is the DSMB statistician and the mentee acts as a silent observer of the DSMB process.
We are also finalising a document to describe the processes involved in a DSMB, with special reference to the roles the various statisticians play during a DSMB meeting. The document describes the composition of a DSMB, the roles of the various statisticians, the purpose of the open and closed sessions and the content of the open and closed reports. We hope to have this document available soon for our members as a reference.
1.2 Grant advice
Do you ever refer to ACTA STInG’s document on ‘Grant Advice for Trial Statisticians’? This document was written in 2017 and it’s time for an update! Keep an eye out for the new version to be released in the coming weeks that includes updates to suggested FTEs, consideration of more complex trials, and advice on requesting salary support for statistical CIs.
1.3 Career pathways for academic biostatisticians
The STInG executive committee in collaboration with the Victorian Centre for Biostatistics (ViCBiostat) have developed a guidance document on Career Pathways for Academic Biostatisticians. This document outlines the characteristics of the three types of work undertaken by biostatisticians working in academia: (1) collaborating on health and medical research studies, (2) conducting methodological research and (3) teaching. It also describes the activities that are conducive to career progression to higher academic levels within each type of work. The document ends with a brief overview of other career paths for biostatisticians. We hope this document will be useful for early and mid-career biostatisticians.
1.4 STInG discussion forum
Earlier this year we launched the STInG discussion forum to provide a support network for trial statisticians to exchange knowledge and to provide a forum to seek advice on tricky trial-related questions. The forum has not been used a lot since its inception, but we encourage STInG members to make the most of this potentially valuable resource to strengthen our network and ensure high quality research.
To access the forum, simply send your email to acta-sting@gaggle.email and it will be disseminated to the forum mailing list.
2 Past events
2.1 Webinar series on Data transparency
There were over 100 registrations for our 3-part webinar series on Data Transparency (Sep 2022) and it isn't too late to watch the recordings.
Tracey Meares (Trial Manager, Health & Clinical Analytics, University of Sydney), Kylie Rogers (Data Management Lead, Adaptive Health Intelligence, Telethon Kids Institute), Laurent Billot (Director, Biostatistics and Data Science Division, George Institute for Global Health), and Ursula Garczarek (Research Principal, Statistical Strategic Consulting, Cytel) discuss the challenges at all stages of the data lifecycle, from study inception to data archive/disposal, and demonstrate strategies to manage and document data integrity based on the ALCOA+ attributes and FAIR principles. The presenters describe the content of Data Management Plans, Data Monitoring Plans, Statistical Analysis Plans, and Trial Integrity Plans, in addition to ethical issues and potential conflicts and some initiatives that may resolve these problems.
2.2 Reproducible reporting in Stata and R
In this two-part series in February, we covered how to produce the same automated statistical report within Stata (Session One), presented by Dr Anurika de Silva, and R (Session Two), presented by Dr Kristy Robledo (slides here). Reproducible research aims to ensure that researchers can reproduce and easily modify their analyses; that researchers, other than those who were involved in the original research, can easily reproduce published work; and that all aspects of an analysis are transparently reported. Key topics of both presentations included reproducibility of the analytic dataset, processes/workflows for statistical analyses, and Stata/R code to create automated reports that allow the results to be reproduced. Like a good, reproducible statistician, the code for these two reports is available here.
The webinars and resources covered in presentations can be found here.
2.3 N-of-1 trials
On 18 April and 2 May, ACTA STInG hosted a two-part webinar series on N-of-1 trials, which are trials in which patients are systematically allocated to repeated episodes of treatment with interventions whose effects are being compared. Prof Stephen Senn, an eminent biostatistician with extensive experience in these designs, outlined the history of the design and analytic methods to estimate average treatment effects from these designs. The seminars attracted over 90 attendees and was well received by all. Recordings of the webinars are available using the following links:
2.4 ACTA STInG-Chat
On 2 August, we held our first STInG-chat session entitled ‘Climbing the Career Cascade: Exploring the Worldly Wisdom and Astute Advice of Two Eminent Clinical Trial Professors’. We had a dynamic discussion with Profs Katherine Lee and Ian Marschner, were they shared tips and advice on key qualities for success, working with clinicians, handling difficult questions and staying up to date with current methods. See the recording and stay tuned for the next session which we plan to host in the first quarter of 2024.
3 Future events
ACTA 2023 International Clinical Trials Symposium (Melbourne)
Hopefully you are aware that the ACTA Clinical Trial Symposium is being held in Melbourne on 27-29 November at the Park Hyatt in Melbourne – see the ACTA website for details. This symposium has a strong focus on methodology this year with co-Chair of ACTA STInG, Katherine Lee, a co-convenor of the symposium. Make sure to register.
During the symposium there are a number of events that are potentially of interest to STInG members detailed below.
· STInG members meeting
On Monday 27 November at 7.30-8.30am there will be a STInG members meeting, which we encourage all STInG members to attend. The meeting will be in person at the Park Hyatt and online for those not attending the symposium. During this meeting the STInG Exec will provide an update on the initiatives of the group over the last 12 months and the plans for the next 12 months. There will also be a chance to provide input into future STInG initiatives. You can confirm attendance at the STInG meeting by emailing amanda.richmond@acta.au.
· Estimands workshop at ACTA
In the afternoon of Monday 27 November there will be a half day workshop on estimands as part of the conference program presented by Sabine Braat, Anneke Grobler and Jessica Roydhouse. The workshop will provide an overview of the estimand framework, intercurrent events, and strategies to handle intercurrent events, as well as practical guidance on incorporating this framework into your protocol and analytic methods for applying the various strategies. The workshop will be grounded in case studies. To attend the workshop you will need to register for the ACTA symposium.
· Seamless Phase 2/3 Designs in Oncology webinar
On Wednesday 8 November, James Matcham, VP Statistical Strategic Consulting at Cytel will present a webinar on seamless Phase 2/3 designs in oncology. He will discuss a number of possible adaptive features, including common designs involve arm dropping for futility, sample size re-estimation, and population enrichment, focusing on the major statistical considerations for designing and analysing such studies, including:
- Planning interim analyses with objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) endpoints
- Controlling type I error in the context of interim analyses and multiple endpoints
- The role of simulations in finalising the design
• Regulatory experience
Register now and mark your calendar for this insightful webinar series!
4 Resources
4.1 Promotion advice
A resource has been developed to assist trial statisticians in planning for academic promotion within their institution. This document outlines specific guidance for the application process and key tips for the interview stages to ensure statisticians are well-prepared, and to ultimately optimise their chances at academic promotion.
4.2 Find a statistician & DSMB directory
As an ACTA STInG member, you have access to the ‘Find a Statistician’area on the ACTA website. This is a directory for Statisticians to be able to search for other Statisticians with experience in a particular area in order to be able to reach out to them for support and collaboration. There is also a specific DSMB directory to find statisticians with DSMB experience. Once signed in, you also have access to “Find a Health economist” underneath “Resources” which has been developed by the health economist special interest group within ACTA.