Interview with Marta Bofill Roig, postdoctoral researcher in Biostatistics at EU-PEARL

 

  1. When and what started your scientific vocation?

I have always been a curious person and have been fascinated by science. But it was when I started my master’s degree in statistics that I became interested in research, particularly in statistics applied to medicine. This combines actual challenges in health with the need to adapt or produce new methods, and the programming to implement so that they can be used more easily.

  1. What is your area of expertise?

I studied mathematics and then did a master’s degree in statistics and operations research.  After that, I completed a PhD in statistical methods for clinical trial designs with multiple outcomes of interest[1],[2]. I now continue to work on clinical trial design and analysis, albeit in a broader way and focusing on adaptive designs.

  1. What attracted you to EU-PEARL?

The EU-PEARL project attracted me in different ways. Firstly, platform trials are a hot topic at the moment, which interested me even before I knew about the project. In addition, EU-PEARL involves academia, industry, hospitals and regulatory agencies. I found this very appealing and adequate to achieve sound results and a fantastic opportunity to work with and be part of an excellent network of researchers. Finally, as refers to the statistical part, this meant for me a new topic to work on and to learn a lot from.

I became interested in research during my master’s degree, particularly in statistics applied to medicine. This combines actual challenges in health with the need to adapt or produce new methods, and the programming to implement so that they can be used more easily.

  1. Which main challenge are you contributing to address?

I work on developing new methods and software for the analysis of platform trials. So far, I have been working mainly on methods for incorporating non-concurrent controls[3],[4]. In platform trials, treatment groups enter into the trial as they become available, which means that not all treatments are studied at the same time, and therefore patients are randomised at different times to the arms available at that moment. For those treatments added later, we are working on methods that incorporate previous data from randomised patients in the control group (so-called, non-concurrent control data) but adjust the analyses to avoid bias. I also collaborate on other research lines to design platform trials for Tuberculosis and Major Depressive Disorder[5], in which I help with statistics and simulations.

  1. What impact will the result of this research have?

As platform trials are a very new type of trial, they require new techniques to analyse the results or refinements of current methods. Our work can therefore help to this end. On the other hand, with the diseases specific working packages, we can get examples of how platform studies can contribute to concrete areas (e.g., Tuberculosis) and what aspects should be considered before setting them up. Hopefully, our ideas will be taken up in real platform trials. To ensure that the methods developed are well accepted by important stakeholders, we organize various sessions on this topic. For example, on February 24th, I co-organize a webinar to discuss the use of non-concurrent control data in platform trials with regulators from EMA, FDA and MHRA.

As platform trials are a very new type of trial, they require new techniques to analyse the results or refinements of current methods. Our work can therefore help to this end.

  1. Thinking about your personal experience in EU-PEARL, what learnings will you take away from your participation in the project?

I think one of the most valuable aspects is the collaborative work. This project allows me to work with many professionals in different sectors and learn from them. With respect to the working group on Scientific, Regulatory and Operational Methodology, I think it is exciting to follow discussions on the different topics being researched. Concerning the working packages on disease specific areas, interdisciplinary work to define what kind of platform trial design is appropriate for that particular disease and what needs to be done to make it happen is also very stimulating. Thanks to all this, I have the possibility to work closely with other researchers such as Stefan Gold and Ekkehard Glimm. Moreover, this project has allowed me to move abroad after finishing my PhD, which I believe fosters my research career and opens new windows for future collaborations.

Marta Bofill Roig is a Postdoctoral researcher at the Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna (MUW). 

 

[1] Bofill Roig, M., & Gómez Melis, G. (2021). A class of two-sample nonparametric statistics for binary and time-to-event outcomes. Statistical Methods in Medical Research, https://doi.org/10.1177/09622802211048030

[2] Bofill Roig, M., Shen, Y., & Gómez Melis, G. (2021). Design of phase III trials with long-term survival outcomes based on short-term binary results. Statistics in Medicine. https://doi.org/10.1002/sim.9018

[3] Bofill Roig, M., et al. (2021). On model-based time trend adjustments in platform trials with non-concurrent controls. https://arxiv.org/abs/2112.06574

[4] Bofill Roig, M., & Krotka P. (2021) Software for Non-concurrent controls in platform trials. https://github.com/MartaBofillRoig/NCC_timetrends

[5] Gold, S. M., et al. (2022). Platform trials and the future of evaluating therapeutic behavioural interventions. Nature Reviews Psychology. https://www.nature.com/articles/s44159-021-00012-0