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Appendix D: Decision Conferencing and Multicriteria Decision Analysis
Pages 255-260

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From page 255... ... Instead, the committee highlights in this appendix two decision tools that incorporate key considerations of benefit–risk assessment relevant to regulatory decision-making: decision conferencing, which is a social process intended to engage all the relevant stakeholders to provide scientific judgments at key points in the decision-making process, and multicriteria decision analysis (MCDA) , which is a technical model for making decisions that have multiple objectives (Walker et al., 2005) Read the entire page →
From page 256... ... Although quantitative estimates result ing from benefit–risk assessment may appear to provide objective information about optimal regulatory decisions, assumptions used in the model are often based on individual judgments about the quality of evidence related to benefits and risks, as discussed in Chapter 3, or based on individual values or preferences for different health endpoints. Using a process like decision conferencing helps to frame the issues and identify the relevant data and evidentiary gaps to guide later data-gathering and thereby improves the efficiency and transparency of the benefit–risk assessment process (Phillips, 2006) Read the entire page →
From page 257... ... Those four steps help to ensure that all participants understand and are in agreement about the need for a regulatory decision, the criteria by which benefit– risk balance is judged, the evidence and its uncertainties, the values and preferences of different stakeholders, and the consequences of different regulatory decisions. The outputs or information synthesis of the benefit–risk assessment stage of the framework should include model inputs and model outputs (Linkov and Seager, 2011) Read the entire page →
From page 258... ... LIMITATIONS OF USING MODELING APPROACHES FOR BENEFIT AND RISK ASSESSMENTS MCDA is a useful tool for benefit–risk assessment, but it has its limitations, both in its own right and as an aid to regulatory decision-making. Using a quantitative MCDA approach to benefit–risk assessment forces participants to be explicit about how they evaluate existing evidence regarding the effectiveness of a drug and its associated harms and about the degree of uncertainty regarding benefits and risks. Read the entire page →
From page 259... ... 2008. Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use. Read the entire page →

From page 255...

... Instead, the committee highlights in this appendix two decision tools that incorporate key considerations of benefit–risk assessment relevant to regulatory decision-making: decision conferencing, which is a social process intended to engage all the relevant stakeholders to provide scientific judgments at key points in the decision-making process, and multicriteria decision analysis (MCDA) , which is a technical model for making decisions that have multiple objectives (Walker et al., 2005)

Read the entire page →

From page 256...

... Although quantitative estimates result ing from benefit–risk assessment may appear to provide objective information about optimal regulatory decisions, assumptions used in the model are often based on individual judgments about the quality of evidence related to benefits and risks, as discussed in Chapter 3, or based on individual values or preferences for different health endpoints. Using a process like decision conferencing helps to frame the issues and identify the relevant data and evidentiary gaps to guide later data-gathering and thereby improves the efficiency and transparency of the benefit–risk assessment process (Phillips, 2006)

Read the entire page →

From page 257...

... Those four steps help to ensure that all participants understand and are in agreement about the need for a regulatory decision, the criteria by which benefit– risk balance is judged, the evidence and its uncertainties, the values and preferences of different stakeholders, and the consequences of different regulatory decisions. The outputs or information synthesis of the benefit–risk assessment stage of the framework should include model inputs and model outputs (Linkov and Seager, 2011)

Read the entire page →

From page 258...

... LIMITATIONS OF USING MODELING APPROACHES FOR BENEFIT AND RISK ASSESSMENTS MCDA is a useful tool for benefit–risk assessment, but it has its limitations, both in its own right and as an aid to regulatory decision-making. Using a quantitative MCDA approach to benefit–risk assessment forces participants to be explicit about how they evaluate existing evidence regarding the effectiveness of a drug and its associated harms and about the degree of uncertainty regarding benefits and risks.

Read the entire page →

From page 259...

... 2008. Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use.

Read the entire page →

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Appendix D: Decision Conferencing and Multicriteria Decision Analysis Pages 255-260

Appendix D: Decision Conferencing and Multicriteria Decision Analysis
Pages 255-260