predictors of health outcomes). To encourage wide participation, the focus of the initiative would be on the qualification process itself, not on any particular type of biomarker.
While the breakout group did not explicitly identify “risk mitigation” from the draft assessment tool as a key factor to consider when evaluating whether to enter into a public–private partnership aimed at developing a biomarker qualification process, it did address risk. Specifically, the group discussed the risk associated with not considering the legal issues that would have to be taken into account to ensure that this type of initiative, and the qualified biomarkers resulting from it, would actually be applicable in the market (i.e., that there would be no postmarket issues around how claims substantiated by the qualification process are being communicated). Likewise, while the group did not explicitly pick “commonality of interests” from the draft assessment tool as a key metric of acceptability, clearly it was an important focus of the conversation.
The calorie reduction breakout group progressed the furthest in terms of identifying a goal for a public–private partnership around a specific issue and identifying key metrics of acceptability from the assessment tool. Many group members supported a focus of their hypothetical partnership on a behavioral research project on calorie reduction. These members identified two specific goals: (1) gauge people’s awareness of “know your number,” possibly using EPODE as a model, and (2) conduct a natural experiment on the impact of front-of-package calorie labeling, using the introduction of front-of-package labeling as a baseline and conducting multicenter clinical trials to evaluate the impact of reduced-calorie products in different communities.
From the draft assessment tool, many group members identified “level of authentic trust,” “commonality of interests,” and “risk mitigation” as key factors to consider when thinking about whether to engage in a behavioral research partnership; “clarity of roles, responsibilities, and accountabilities” as an important factor to consider when evaluating development of the partnership; and “evaluation,” not just of the research but also of the partnership itself, as a key factor to consider when assessing whether the partnership has reached its goal(s).
Reflections on Applying the Draft Assessment Tool to Possible Partnership Projects
Most participants reflected that discussing cross-sectoral collaboration in the context of concrete issues, such as those addressed during the