5.2. Regulating an Open Science
Background: Following the Supreme Court’s ruling in Prometheus v. Mayo that basically excluded biomarker diagnostics from being patented, the field is now operating under an “open science” model. Under such a model, no stakeholder is responsible for controlling or directing research activities, and therefore, the many uncertainties about how to use and interpret biomarker test results have to be resolved through the passive mechanisms of scientific coordination (e.g., publication, conferences, word-of-mouth). In previous work, we have argued that these passive mechanisms are insufficient to deal with the increased complexity of components and procedures that make up a biomarker diagnostic. There is therefore a need for novel mechanisms that can help structure and guide an “open scientific community” toward more systematic and efficient testing of novel biomarker technologies.
Aim: To model the effects of various regulatory interventions on replication, validation, and efficiency of biomarker diagnostic development.
Approach: We will use our collected empirical data on the patterns of research activities to construct a dynamic, agent-based model for how researchers operating under an “open science” model explore the parameter space of a biomarker ensemble. We can then simulate the effects of various regulatory interventions on efficiency and scientific coordination in this space to generate hypotheses for future regulatory policies. For example, does a scientific community converge on the optimal biomarker ensemble more quickly if each investigator is given more information about what the others are doing? Does the community converge more quickly if the regulator grants investigators exclusive rights and responsibilities over certain regions of the parameters space?