As part of the PDUFA V commitment, the FDA held a public workshop on benefit-risk assessment. Read the summary of the meeting here on the RAPS website. The slides are published on the FDA website, and you can get them here.
Patient preferences can help us to inform the weighting of different outcomes against each other.
In questions like “How much more efficacy is needed to outweight tolerability issues?” preferences by patients or other stakeholders could play a key role in quantitative benefit-risk assessments.
The 1-hour webinar takes place on October 24th at 4pm CET, 3pm UK time, and 10am ET in the US.
There will be lots of time for discussions after the presentation.
Registration is closed now. But register for our newsletter and you will not miss a future webinar!
Kevin Marsh will speak in our webinar about
Do patient preference have a role in Health Technology Assessment? Current practice and future potential
Abstract: Both regulators and payers are actively exploring how they might use quantitative estimates of patient preferences to support their decisions. This is evident in initiatives such as IMI PREFER.
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.
At the population approach group (PAGE) conference in Budapest, Hungary, 4 interesting presentations about benefit-risk were given and the abstracts as well as the slides are now online available here:
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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
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 takes 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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The Effects Table (ET) has become one of the most common tools in the area of Benefit-Risk Assessment. It displays a concise summary of the key benefits and risks of a new product compared to either placebo or an existing product. See here on more insights into what an effects table is and why it is helpful.
On initial inspection, it may look simple to create. However, those who have already tried to do the exercise know that it is not at all easy.
In our 1-hour webinar on the 12 of July 2017 (4:30pm CET, 3:30pm GMT, 10:30am EST) we had a presentation by Conny Berlin who is the industry project leader of the public-private IMI PREFER project and by Rachael L. DiSantostefano member of IMI PREFER. They talked about:
Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle: PREFER – an IMI Project
by Conny Berlin and Rachael L. DiSantostefano
The replay of the webinar including the Q&A is now available here:
The main objective of the IMI PREFER project is to strengthen patient-centric decision making throughout the life cycle of medicinal products by developing evidence-based recommendations to guide industry, Regulatory Authorities, HTA bodies, reimbursement agencies, academia, and health care professionals on how and when patient-preference studies should be performed and the results used to support and inform decision making.