Value-of-information (VOI) analysis is a potentially useful tool for deciding whether further research is needed (Claxton et al., 2001; NRC, 2009). VOI helps determine whether or not it is worthwhile to collect additional information or conduct additional research, prior to making a decision (Ginnelly et al., 2005). The expected VOI is calculated by weighing the change in the potential net benefits to the population from the decisions from obtaining that information. If the information would not alter a regulatory decision, the VOI is zero (Ginnelly et al., 2005; Raiffa, 1968). Even if not formally applied, it provides a very helpful conceptual framework for deciding when and what types of research are needed by linking this determination to subsequent decision-making.
VOI analysis can be used to identify when and how a decision-maker’s preferred option might be changed if the decision-maker were able to incorporate additional information into the decision (NRC, 2009). In other words, VOI analysis describes the relationship between the knowledge that might come from the considered source of information and its potential for improving decision outcomes, and it can help to establish a threshold for specific regulatory decisions. The analysis enables regulators, given the current state of knowledge, to evaluate the likely health benefits of various courses of action, including a decision to gather more information.
VOI analysis allows decision-makers to weigh the value of additional evidence against the potential risks posed by delaying a regulatory decision until the information is available (NRC, 2009). That assessment is an important part of the benefit–risk management decision-making process, it helps to determine whether to seek a postmarketing commitment (PMC) or postmarketing requirement (PMR).
VOI analysis has important limitations. It does not measure the scientific merit and broader utility of a study and therefore is not a substitute for the analysis of these issues. For the same reason, traditional VOI is helpful for determining whether to seek a PMC or require a PMR and less well suited to determine which types of studies are most appropriate for producing the evidence sought.
• when a drug is expected to have a different benefit–risk profile under real-world conditions or in specific patient groups;
• when a drug belongs to a class in which a substantial safety signal has previously been identified; and
• •when evidence emerges in the postmarketing setting that suggests a lack of benefit.