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Introduction to Benefit-Risk Assessment

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Interview with Maria Costa and Shahrul Mt-Isa

Benefit-risk assessments are made by various stakeholders including sponsors, regulators, payers, physicians, and patients throughout the life-cycle of a treatment.

The understanding of data plays a vital role in weighting positive and negative effects of medications.

In this episode, we give you an introduction to what benefit-risk (BR) assessment is in order for you to understand your role.

We also cover the following topics:

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Introduction to cluster analysis

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Not all patients are created equal, but are there subgroups that are more homogenous?

This episode follows the outline of a webinar, that I presented in 2018 during a PSI webinar. I’m introducing cluster analysis and why you as a statistician need to know about it.

The title of the presentation was “Not all patients are created equal, but are there subgroups that are more homogenous?”

If you wonder about questions like:

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Current trends in data science for pharma – findings from a qualitative survey and what we should do about it!

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Interview with Ursula Garczarek

Do you want to learn where the health sector might be heading in terms of data science?

Do you understand the opportunities and barriers in terms of the application of data science?

Are you prepared to learn the individual skills needed for these changes?

Then this interview with Ursula from Cytel provides you with the relevant answers. We are talking about:

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The rise of R and what role the AIMS SIG plays in it

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Do you think, R can’t be used for regulatory submissions?
Are you forced to use SAS but would like to use R instead?
Would you like to understand how you can make R submission proof?

Then this interview with Lyn Tailor and Craig McIlloney helps you. Both work on the PSI special interest group Application and Implementation of Methodologies in Statistics (AIMS) on this topics.

Furthermore, we cover the following topics:

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Best of the episodes from 2018 and outlook for 2019

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Happy Christmas! This episode is the last one in 2018 and we will distil the best of the last 40 episodes for you in this Christmas edition of the podcast.

It has been anamazing journey and we will talk about the challenges and the learnings as well as the achievements of the podcast itself. Thus, you’ll get a behind the scenes look into the podcasting work.

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The podcast is run in association with PSI