PubMed · 12408009
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Andrea Callegaro, Maria Grazia Valsecchi. [Methodologic problems in the analysis of competing risks].. https://pubmed.ncbi.nlm.nih.gov/12408009/
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INTRODUCTION: A positive benefit-risk profile is a prerequisite for the market approval of medical devices. However, regulations are often criticized for providing limited information on benefit-risk assessment (BRA) despite growing expectations for quantitative methods. A clearer understanding of regulatory requirements, existing methodologies, and unresolved issues is needed. AREAS COVERED: Relevant regulatory documents referencing BRA for medical devices were systematically identified, with a primary focus on the European regulation followed by screening to extract BRA‑related requirements and any explicitly or implicitly described methods. The findings were analyzed and consolidated by BRA context, type, objective, methodological description, and implementation, thereby establishing a basis for the BRA methodological landscape. EXPERT OPINION: BRA is not a single concept, but a set of context‑dependent assessments across lifecycle of a medical device. BRA within clinical evaluation framed into BRAs of risk management holds a pivotal role and is supported by the most detailed methodological guidance, although BRAs in other contexts are important. A structured overview of existing BRA requirements clarifies their treatment across regulatory documents. By differentiating BRA contexts, types, objectives, and required methodological detail, the analysis supports a more transparent understanding of BRA and helps identify priorities for methodological refinement and interface clarification.
New technology, and in particular new molecular biology tools, have opened up access to new generations of vaccines or control tests. DNA vaccines are of particular interest since only the gene is injected and, as a consequence, specific risks are associated with this kind of vaccination. Some strategies are presented here to improve DNA vaccine efficacy, which can in some cases result in the reduction of the quantity of plasmid needed and therefore limits the risk. Specific tools to study the distribution of plasmids inside the body as well as tools to detect plasmid insertion inside the host genome have been developed. A final part of this paper will present briefly the new tools which have been or can be developed to detect contaminants in vaccines.
This study determines how the recent wave of litigation affected returns and systematic risk in the tobacco industry. We test for changes in stock prices coinciding with litigation announcements using a difference-in-difference event study methodology. Unfavorable information concerning litigation reduced tobacco returns. We find a decline in systematic risk as traditionally measured by the covariance between industry returns and returns to a diversified (efficient) portfolio. This decline may imply a substantial decline in the cost of equity capital of at least 2.2% after the period of litigation, which we attribute to common cost shocks experienced by the companies participating in the Master Settlement Agreement combined with the oligopolistic structure of the industry.