We caught up with our senior statistician, Marion Procter, to learn about her journey into statistics and her involvement with the HERA trial. This study influenced changes in the standard of care for those with HER2-positive breast cancer.
Statistics in the blood
Growing up with a maths teacher mother, a physics lecturer father and brothers who all studied STEM-related subjects at university meant that by the time Marion was 14 years old, she was already aware that she wanted to pursue a career in statistics. At the same time, Marion decided that medical trials were how she wished to apply her future learning.
With this goal in mind, Marion chose school subjects (she studied English, Maths, Physics, Chemistry and French at Higher) and an undergraduate degree (an MSci in Statistics from the University of Glasgow) to support her plans. It also influenced her choice of studentship while at university.
A career centred on HER2-positive breast cancer clinical trials
While completing her final year of university, Marion spotted a job advertised by none other than Frontier Science Scotland. At that time, we were looking for a statistician to work on HERA, a large-scale global breast cancer medication trial. As well as fulfilling a long-held wish to work on clinical trials, this job offered Marion the opportunity to be mentored by Dr Richard Gelber, a renowned Harvard statistician. Dr Gelber, working for Frontier Science USA, was the senior statistician for HERA, and he remains on the FSS Board to this day.
Marion’s role in HERA included working with the sponsor on the Statistical Analysis Plan and carrying out formal analysis for the HERA trial. In this early role, Marion was one of the first to see the extraordinary results from the interim analysis of the HERA trial in 2005, which had a one-year median follow-up.
“I didn’t believe it,” she laughs. “You just don’t see results like that. And it was the first real efficacy analysis I had ever done. It took me quite a while to convince myself that what I was seeing was true.”
The results in question showed that one year of treatment with trastuzumab after adjuvant chemotherapy significantly improved disease-free survival among women with HER2-positive breast cancer. It wasn’t only Marion who was impressed: the results astounded even highly experienced statisticians and clinical trial experts. The results of the HERA trial were published in the New England Journal of Medicine and the resulting article, for which Marion was second author, remains her most cited publication — despite the successful 18-year career that has followed.
Marion worked on HERA until follow up ended in 2015, taking on more responsibility as time passed. She says she enjoyed being one of the few people involved in the entire study lifecycle. “It felt rewarding,” she affirms, “in the sense that I got to see all the questions answered.”
When asked what it is about working in statistics for clinical trials that is so appealing, Marion’s immediate response was, “You feel your work matters and you’re doing something useful. You’re actually helping patients.”
A collaborative approach benefits all
Since the initial results were published, Marion has been involved in many related research projects. She explains that all the partners – Roche, Breast International Group (BIG) and Institut Jules Bordet (IJB) (formerly known as BrEAST) – felt there was more scientific knowledge to be learnt from the data than just the main question about disease-free survival. They all wanted to make the most of the fact that so many patients had been willing to be part of a long-running trial.
As well as these spin-off research projects – and other unrelated studies, FSS has worked on two successive clinical trials to HERA. Marion herself has been involved with the APHINITY study since 2010, and other colleagues have been active in the ALTTO study. Like HERA, both examine the efficacy of HER2-positive breast cancer medication.
It’s clear that the HERA clinical trial continues to deliver benefits to this day, as the knowledge gained by those involved has influenced the design of successive studies. Marion mentions the lessons she learned about the benefit of close collaboration between all trial partners and, more specifically, how the design of the electronic case report form (eCRF) for APHINITY was influenced by the experience gained in HERA. .
Marion’s journey into statistics, and her dedication to HERA and subsequent trials, reflects the impactful and rewarding nature of statistical work in clinical trials – where every analysis contributes to improving patient outcomes.