A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration (2011) / Chapter Skim
Currently Skimming:
7 Conclusions and Future Directions
7 Conclusions and Future Directions
Pages 139-148
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 139... ...
The decision focus of the framework, specifying and comparing the outcomes of specific decisions, did not come naturally to committee members who had more detailed scientific expertise related to FDA products and product categories. They were initially inclined to look more broadly at the effects of the product being considered, and some iteration and detailed discussion were necessary to narrow the focus of discussion to the comparison of specific options.
|
From page 140... ...
The decision analysts on the committee were able to focus the subjectmatter experts on a relatively constrained decision context, to identify the sequence of information needs, and to assist the subject-matter experts in making judgments about the array of possible effects on the basis of sparse data. The decision analysts, of course, could not provide the specialized and detailed knowledge necessary to identify and recognize the most relevant data for a specific decision context.
|
From page 141... ...
For example, estimates of the number of people exposed to the risk of foodborne illness caused by pathogens in leafy greens required an estimate of the number of people who consume leafy greens in a year, which could be based on readily available information on food consumption. In more complex cases, a series of estimates and relatively complex calculations were used to derive estimates for the attribute table.
|
From page 142... ...
To develop the final estimate, the committee had to identify and structure the various factors and their relationships, estimate each of the critical factors (by using a combination of descriptive histories, bounding analyses, and judgment) , and calculate the resulting numbers (in this case, using Monte Carlo simulation methods)
|
From page 143... ...
In all cases, assumptions were necessary about how to interpret the data to complete the risk-attribute table. Among the case studies, evaluating the potential strategic-investment decision of enhanced postmarket surveillance of implanted medical devices proved challenging with respect to data and the need to rely more heavily on "pure" expert judgments.
|
From page 144... ...
The framework provides a structured way to document the data and the associated expert judgments clearly; as the framework is used more extensively, some of the analyses and data sources used for earlier studies can be leveraged to make related studies less burdensome, although some new data and new expert judgments will probably be required. Using the Risk Characterization to Support Decision-Making The risk-attribute table provides a succinct comparison of the decision options that were evaluated and should be useful to decision-makers interested in understanding the key differences in the public-health consequences of those options.
|
From page 145... ...
On the basis of its experience in developing the case studies, the committee found that it is possible to characterize decision options by using the risk attributes and that they could be estimated by using existing data and expert judgment. The judgments that were required were not always easy, and committee members were not always comfortable in making them, but in the end the committee concluded that the case studies would provide useful, relevant, and sufficiently accurate information to be of use to a decision-maker.
|
From page 146... ...
FUTURE DIRECTIONS As a result of its efforts to develop the risk-characterization framework and the case studies, the committee offers the following suggestions concerning implementation of the framework: FDA should consider using the concepts defined by the riskcharacterization framework and particularly the risk attributes defined in the present report as a common language for discussing risk-related aspects of various decisions. In risk-related decisions, considering the outcomes of alternative decisions in terms of the attributes identified in the present report will begin to establish consistency in risk vocabulary throughout the agency and will build a base of understanding that will enable more detailed use of the approach for evaluating and comparing decision options in the future.
|
From page 147... ...
Presentation at the 5th Meeting on Ranking FDA Product Categories Based on Health Consequences, Phase II, February 3, 2010, Washington, DC. Charles, C., A
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.