For the implementation of quantitative benefit-risk approaches, the elicitation of patient preferences is key. However, it’s not clear, how to best do this. Tervonen et al. have compared swing weighting and discrete choice experiments (DCE) with respect to
- comprehension by study participants
- cognitive biases
- representatives of population preferences
- capturing heterogeneity
- reliability and validity
- robustness of the results.
This paper provides a very nice qualitative overview of these points. However, empirical studies comparing these approaches are still missing. Find the paper here:
“MCDA swing weighting and discrete choice experiments for elicitation of patient benefit-risk preferences: a critical assessment.”
Medical Device Innovation Consortium
The FDA will host a public workshop on Benefit-Risk for decision-making in drug development on the 18th of September.
This meeting will focus on:
- Regulatory and industry experiences with approaches to structured benefit-risk assessments.
- Approaches to incorporating patient perspectives into structured benefit-risk assessment.
- Exploration of methods to advance structured benefit-risk assessment.
The workshop is free and can be attended in person or through a webcast (details on how to register can be found in the link above).
July 12, 2017
Eva Katz, PhD, MPH, RD
Recently, we shared an example of adopting benefit risk methodology to schizophrenia studies (click here for more information). Now we are happy to announce that Eva Katz, the epidemiologist behind this nice case study, will give a webinar about it and there will be the possibility to have a discussion around this and how other areas can benefit from it.
The 1 hour event took place on September 26th. 4pm European time, 3pm UK time, 10am Eastern time in the US.
Here is a short bio of Eva:
Eva Katz, PhD, MPH, RD is Associate Director of Benefit-Risk and Epidemiology at Janssen Research & Development. In this role Dr. Katz serves as an internal consultant for benefit‐risk methodology and patient‐focused benefit‐risk assessment, guiding clinical teams across therapeutic areas in medication benefit-risk assessment using both qualitative and quantitative methods. As part of the efforts to integrate the patient experience in clinical trials, Dr. Katz has helped integrate patient and physician preference surveys within phase 3 clinical trials. Eva also participates in external task forces on benefit‐risk assessment methods and patient focused drug development. Prior to her role in Benefit-Risk, Dr. Katz was part of the patient reported outcomes team at Janssen where she worked cross‐functionally to develop strategy for development, selection and implementation of Patient‐Reported Outcomes (PROs) in phase 2 and phase 3 clinical trials of pharmaceutical products across therapeutic areas. Dr. Katz received her B.S. in Nutritional Science from Rutgers University, her M.P.H. from the University of California, Berkeley and her doctorate in Nutrition Epidemiology from the Gillings School of Global Public Health, University of North Carolina, Chapel Hill.
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