A survey to assess the current status of structured Benefit-Risk assessment in the global drug and medical device industry-Reference-Cited by-同舟云学术

A survey to assess the current status of structured Benefit-Risk assessment in the global drug and medical device industry

Published:2023-06-14 Issue: Volume: Page:
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Author:

Gebel Martin¹,Renz Cheryl²,Rodriguez Lisa³,Simonetti Arianna⁴,Yang Hong³,Edwards Brian⁵,Higginson James Matthew⁶,Charpentier Nicola⁷,Colopy Michael⁸

Affiliation:

1. Bayer AG, Statistics & Data Insights

2. Convene Pharma Consulting, LLC

3. U.S. Food and Drug Administration

4. U. S. Food and Drug Administration

5. Husoteria Ltd. Ashtead

6. Merck KGaA

7. BioNTech (Germany)

8. UCB Pharma (United States)

Abstract

Abstract Background This industry survey was conducted to gain insight into the ways structured Benefit-Risk assessment (sBRA) of medical products is approached across drug or medical device developing companies, including frameworks and methods that are currently used and areas where future work is being planned. Methods A survey containing 28 questions covering five key areas of sBRA was set-up and shared with representatives from the participating companies. Each company was asked to complete a single survey response including inputs across the company’s multidisciplinary key representatives involved in benefit-risk assessment. Results Of the 26 participating companies, 21 are conducting sBRA. Qualitative frameworks were used by almost every company (19), while only 12 have used a quantitative method. Many companies have sBRA training (17), document templates (16), Standard Operating Procedures (SOPs)/checklists (13), and /or best practice manuals/examples (12) available. Software tools (15/26) and BR planning documents (11/26) were identified as areas into which many companies intend to put effort. Conclusions The industry survey confirmed a wide usage of sBRA by many companies involved in research and development. Nevertheless, sBRA is evolving and several future opportunities like the implementation of visualization tools were identified by the representatives of the pharmaceutical companies. Finally, challenges like the cross-functional comprehension of the added value of sBRA are still seen.

Publisher

Research Square Platform LLC

Reference26 articles.

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4. US Food and Drug Administration. (2013). Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making. Draft PDUFA V Implementation Plan. Fiscal Years 2013–2017. Available at: http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM329758.pdf.

5. US Food and Drug Administration. (2019). Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications. Guidance for Industry and Food and Drug Administration Staff. Avalaible at: https://www.fda.gov/media/99769/download.