Enabling statisticians to lead through innovation and excellence - sponsored by PSI
Have you ever considered to work with a placement student?
Do you consider to spend some time as a placement student yourself?
In this interview with Katie Thorn and Claire Brittain, we’re exploring factors, which help to make it a win for both sides. Both have worked very well together and share their stories. We step into questions such as:
[Read more…] about How to work effectively as and with a placement student – a success story with Katie and ClaireI recently talked to a statistician, that initiated a small company internal group of statisticians to drive forward methodological innovation projects. While this surely will help the individuals to learn more about statistical methods, it was less clear, why and on which topics the group should focus their activities on.
While most of our day-to-day activities consists of running clinical studies, submissions and directly related work, we also engage in such innovation work streams or process improvement working groups and other such activities.
Today, we’re giving you advice on how to best pick the right projects to work on as you usually have some influence on this.
Specifically we cover the following questions, you should ask yourself first:
[Read more…] about Questions to ask yourself before starting a new projectAs statisticians in the medical field, we’re used to study subgroups of patients with respect to all kinds of biological variables: from demographics to genomics. This provides us with a good understanding of how the benefit-risk profile for a given patient looks like.
However, the patient might have a completely different view on the importance of the different benefits and risks. And importantly, these preferences might be less driven by biologic factors and more by personal experiences and situations as well as psychological traits. How can we assess patient preferences in this regard?
Marco Boeri and I worked on such questions in the past and some work has been presented at last years PSI conference. In todays episode, we give you some insights into what’s possible and how you can approach this problem.
We’ll dive into questions like:
[Read more…] about Understanding heterogeneity for patient preference data and how it effects the benefit-risk ratio for treatmentsEstimands continue to be a hot topic, but many statisticians struggle to put it into practice. As statistician, we wonder about the correct interpretation and how to analyse different estimands.
In todays episode, we speak with Michael O’Kelly, an expert on this topic with lots of presentations around estimand (see e.g. the PSI events). He also won the award for Statistical Excellence in the Pharmaceutical Industry, jointly run by the RSS and Statisticians in the Pharmaceutical Industry (PSI).
In the interview we will dive deep into a specific approach – the composite strategy – and cover questions like:
[Read more…] about Useful tips to apply the composite estimands strategyOne of the most common questions I got asked during my nearly 2 decades of being a statistician sounds similar to this: “Which patients have the best response to treatment?”
I’m sure, we all face this situation sooner or later and not surprisingly lots of research has happened in the last years on this area. In todays episode, we will help you to understand one of the best approaches I have come across to solve this problem in a rigorous yet sophisticated way: the SIDES approach.
Both Andy Nicholls and I have applied this approach in the past and we’ll use an example, which he presented during a PSI webinar.
Listen to this episode to learn step by step how to apply the SIDES method.
[Read more…] about Subgroup identification using SIDES and its practical challengesPrespecified=good and post-hoc=bad. This is how we as statistician see it usually and I did too. However, over the past years I realized more and more, that it’s not that easy.
How many details do you need to have to call an analysis pre-specified? Should we label a request to analyse a certain subgroup by regulators as well as a fishing expedition to find a significant subgroup both in the same way: post-hoc?
[Read more…] about 50 shades of pre-specification
