Decision conferencing is a tool that brings key experts and stakeholders together to generate a shared understanding of a challenge, create a sense of common purpose, and gain commitment to a way forward (Phillips, 2006) to aid evaluation and assessment of the benefits and risks associated with a drug (Walker et al., 2005). Decision conferencing has four basic elements: attendance by key stakeholders (for example, regulators; methodologists who have expertise in design, conduct, and analysis of observational studies and clinical trials; decision scientists; physicians who have relevant clinical expertise; patients; and the public); impartial facilitation to guide discussions of estimates of benefit and risk, degree of uncertainty, and values and preferences for health endpoints; on-the-spot modeling with continuous display of the developing model; and an interactive and iterative group process (Phillips, 2006). When quantitative benefit–risk assessments are needed in situations in which disagreements about appropriate regulatory action arise, a neutral facilitator can guide the group through the stages of discussing the issues, developing models for evaluating the issues, and eliciting assumptions about the quality of evidence regarding benefits and risks and about underlying ethical values and preferences for health endpoints without contributing to the content of discussions. Although quantitative estimates resulting 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).
The decision-conferencing process could be integrated into FDA’s current processes and requirements under the Federal Advisory Committee Act,1 and it is similar to initiatives that FDA currently has planned. For example, FDA is working with stakeholders, using faculty of the George Washington University as facilitators, to develop guidance material for approving obesity drugs (McCaughan, 2011). Decision conferencing in benefit–risk assessment has four advantages:
• It facilitates and focuses thinking about a complex challenge.
• It helps to establish common purpose among participants and commitment to move forward.
• It promotes transparency and a shared understanding of how stakeholders define benefits, risks, degree of uncertainty, ethical values regarding outcomes, and potential regulatory actions for managing risk.
1Federal Advisory Committee Act, PL 920-463, 86 Stat. 770 (1972).