The Effective Statistician - in association with PSI

Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry
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May 25, 2022 • 39min

Extrapolation to paedriatics

Interview with Andrew Thomson Stay tuned while Andrew and I talk about the following: What is extrapolation?What are source and target populations?The guidance states: “Where possible, quantitative methods should be used for the collation of available data and the investigation of potential modifiers of the treatment effect”. How could such quantitative methods look like?What are the major challenges?
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May 16, 2022 • 35min

How to integrate external data into your clinical studies: from theory to application

Interview with Gaëlle Saint-Hilary We also discuss the following points: What is dynamic borrowing?What are the impacts on sample size and effective sample size?How do we best make decisions based on the final results? Listen to this episode and share this with your friends and colleagues!
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May 10, 2022 • 29min

A pre-view into the PSI conference

Here are some of the points we talked about: Contents of the conferenceNetworking opportunitiesSpecial interest group involvementLearning and contributing ideas Estimands sessionsMachine learningHistorical data sessionsand more.. Hoping to see you in Gothenburg! Register here: https://b-com.mci-group.com/CommunityPortal/Registration/2022PSICON.aspx?registrantID=1bf7dac5-4dd2-45de-ae1e-110901512f47 References https://www.psiweb.org/conferences/agenda https://www.psiweb.org/conferences/social-programme
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May 3, 2022 • 60min

Patient-reported outcomes and the FDA Patient-Focused Drug Development Guidance

Interview with Rachael Lawrance Stay tuned as we also talk about the following points: What's in the 4 guidelinesWhat factors should be considered when constructing COA-based endpoints?Effect of disease type (e.g., acute, chronic) on endpoint selection – acute symptoms resolve within weeksTreatment objective (e.g., cure, symptom management)PopulationEndpointIntercurrent Events – What can affect your measurements interpretationPopulation level summary - What Is the Final Way All Data Are Summarized and  Analyzed? References: FDA Patient focused drug development guidancePFDD Guidance 4 workshop discussion documentPublic Workshop (Dec 2019)Meeting slides Listen to this episode and share this with your friends and colleagues!
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Apr 26, 2022 • 29min

Apps on prescription paid by the government

Interview with Dr. Stefan Walzer Stay tuned and listen while we talk about the following points: What are some of the risk classifications?How does the process work to get a DIGA on the list of reimbursed?What is required to get a DIGA on this list? Listen to this episode and share this with your friends and colleagues!
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Apr 18, 2022 • 44min

What does it take to develop good patient-reported outcomes?

Interview with Antoine Regnault Stay tuned and listen while we talk about the following points: How do capitalizing on existing instruments while improving them produce good patient-reported outcomes?What is an "Item Bank"?What is the data you need to gather first before developing new instruments and items? Listen to this episode and share this with your friends and colleagues!
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Apr 12, 2022 • 43min

What is the current state of Launch and Lifecycle work and how did it evolve?

Interview with Jenny Devenport This is a series of episodes and today's content is the first episode. Join Jenny and I while we dive into her career and discuss important points about the following: What is Launch and LifecycleHow as it evolved in the last 2 decades with respect toPhase IV studiesObservational studiesRWEHTAGlobal vs local positionsWhat is the relationship between HTA vs non-HTA areas and collaboration with stakeholdersCollaboration with the regulatory sideInvolvement in strategic evidence generationNumber of statisticians/programmers supporting this areaOrganization within or outside of statistics departments Outsourcing approaches (strategic parts, RWE and outcomes research, studies, NMA/health economics) Listen to this episode and share this with your friends and colleagues!
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Apr 5, 2022 • 40min

The best of causal inference

Interview with Miguel Hernan In today's episode, we will be diving deep into this interesting topic and talk specifically about the following: How did you get interested in causal inferencesIf we have an observational study with 2 arms and differences in baseline variables, what are the best ways to adjust for these?What does this look like for multiple treatment arms?In longer studies, we happen to see switches between different treatments. How do we compare treatments appropriately in these cases? References: Wikipedia: Miguel HernanHarvard TH Chan Listen to this episode and share this with your friends and colleagues!
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Mar 29, 2022 • 26min

Replay of Interview with Nigel Howitt on getting most out of a PSI membership

Interview with Nigel Howitt After a short introduction of Nigel and his experience with PSI, we will cover the following topics: https://cdn.podigee.com/podcast-player/podigee-podcast-player.html?id=pdg-1549a3b9&iframeMode=script How can someone, that is interested become a new PSI member?What rules are there for students?If you’re a data scientist in the pharma industry- is PSI the right association?How to get most out of PSI?What are the different ways, you can become more engaged within PSI?How can you get involved with one of the PSI committees? What’s the role of the SIGs and how do you get involved there?What Nigel is recommending new members of PSI as first steps?What are your highlights of the PSI conference in Amsterdam? Finally, we’ll also discuss how to get most out of the conference.
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Mar 22, 2022 • 45min

How to say NO

Interview with Liane Davey In this episode, Liane Davey, who is the author of the book "The Good Fight", and I will be discussing about how to say no effectively. I met her on Linkedin and we had a couple of messages and it was just really cool that we think the same way. Stay tuned because you'll surely love it! We discuss about the following points: How to say noHow to build boundariesHow to say it effectivelyHow do we embrace conflict: The Good Fight BookHow buffer in our schedule and "no" relate to each other Share this interesting episode with your friends and colleagues who'll surely love it too!

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