The Highlands local group held one seminar on 26th May.
Statistical Aspects of the Frontier Science Scotland (FSS) Collaboration in Oncology with the Breast International Group (BIG)
Local group members joined 16 Frontier Science Scotland (FSS) staff for the seminar on 26 May 2024 on their collaboration in oncology with the Breast International Group (BIG). The seminar gave an overview of the statistical aspects of the collaboration in the APHINITY and OlympiA trials.
APHINITY investigates dual anti-HER2 therapy in early HER2+ positive breast cancer. HER2+ positive tumours are associated with aggressive breast cancer. The collaboration involved a protocol amendment with a change in eligibility criteria and sample size. Andrew Bailey described different options considered and their statistical impact.
OlympiA involves patients with high-risk HER2- early breast cancer. It assesses the efficacy and safety of a poly ADP ribose polymerase (PARP) inhibitor olaparib. The primary endpoint is iDFS with secondary endpoints including overall survival (OS) and distant disease-free survival (DDFS). There were two substantial amendments to the study design, altering the eligibility criteria and increasing the sample size. Christine Campbell discussed the bespoke alpha-spending that was planned to control the family wise error rate (FWER) over multiple endpoints and timepoints.
Marion Procter closed by outlining ongoing work in clinical trials on estimands.
Speakers from FSS
Frontier Science Scotland is a not-for-profit contract research organisation (CRO) based in Kincraig, with over 20 years of experience designing, running and analysing the results of clinical trials and specialising in data management, biostatistics, and quality services. The speakers Marion Procter, Andrew Bailey and Christine Campbell are part of the biostatistics team at FSS.