Introduction to Benefit-Risk Assessment

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:

  • What are the different situations, where BR becomes important?
  • What is the difference between qualitative and quantitative BR assessments?
  • Which relevant parties work on this topic?
  • What are good resources to get started with BR and how will they help?
  • What would you recommend as further readings and how can I get additional training?
  • What is the BR SIG doing and how to become a member?

About Maria Costa

Dr Maria Costa completed her PhD in Statistics at Warwick University in 2008 where she worked on developing new approaches for generalized additive and survival models using penalized spline functions. Dr Costa then became a Research Fellow at the Warwick Systems Biology Centre working on the connection between the circadian clock of plants and global warming as part of the ROBuST project.

Dr Costa has worked in the pharmaceutical industry since 2013, starting at GlaxoSmithKline R&D where she focused on developing methodology for quantitative Benefit-Risk assessment, as well as providing statistical consultancy on complex clinical trial designs to multiple projects across R&D. Since 2018 Dr Costa has joined Novartis Pharma as an Associate Director in Biostatistics.

Dr Costa is interested in the fields of benefit-risk assessment, Bayesian inference, adaptive designs, probability of success.

About Shahrul Mt-Isa

Dr Shahrul Mt-Isa is a Principal Scientist in the Health Technology Assessment (HTA) Statistics research group under the MSD Research Laboratories (MRL) Biostatistics and Research Decision Sciences (BARDS) organisation. He is responsible for statistical analyses in clinical study portfolios in antiviral, antibacterial, and oncology indications to support HTA dossiers submission globally.

He co-leads the MRL Benefit-Risk (BR) Strategic Initiative to innovate and implement novel methodologies and processes for BR Assessment. Externally, he is an active member of the EFPSI BR and HTA Special Interest Groups.

Prior to joining MSD, he was the Deputy Public Lead in the IMI-PROTECT BR Work Package (WP5) while serving as an academic statistician at the School of Public Health, Imperial College London, where he currently holds an Honorary Fellowship.


Click here to get to the pre-conference course of PSI 2019!

Click here to access the homepage of the BR SIG!

Read the aims of the SIG on the PSI homepage!

Link to a replay of the webinar about IMI PREFER and patient preferences!

Bayesian joint modelling of benefit and risk in drug development

The Case for a Bayesian Approach to Benefit-Risk Assessment:: Overview and Future Directions

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