title: Optimal global value of information trials: better aligning manufacturer and decision maker interests and enabling feasible risk sharing.
abstract: Risk sharing arrangements relate to adjusting payments for new health technologies given evidence of their performance over time. Such arrangements rely on prospective information regarding the incremental net benefit of the new technology, and its use in practice. However, once the new technology has been adopted in a particular jurisdiction, randomized clinical trials within that jurisdiction are likely to be infeasible and unethical in the cases where they would be most helpful, i.e. with current evidence of positive while uncertain incremental health and net monetary benefit. Informed patients in these cases would likely be reluctant to participate in a trial, preferring instead to receive the new technology with certainty. Consequently, informing risk sharing arrangements within a jurisdiction is problematic given the infeasibility of collecting prospective trial data. To overcome such problems, we demonstrate that global trials facilitate trialling post adoption, leading to more complete and robust risk sharing arrangements that mitigate the impact of costs of reversal on expected value of information in jurisdictions who adopt while a global trial is undertaken. More generally, optimally designed global trials offer distinct advantages over locally optimal solutions for decision makers and manufacturers alike: avoiding opportunity costs of delay in jurisdictions that adopt; overcoming barriers to evidence collection; and improving levels of expected implementation. Further, the greater strength and translatability of evidence across jurisdictions inherent in optimal global trial design reduces barriers to translation across jurisdictions characteristic of local trials. Consequently, efficiently designed global trials better align the interests of decision makers and manufacturers, increasing the feasibility of risk sharing and the expected strength of evidence over local trials, up until the point that current evidence is globally sufficient.
authors.affiliation: Australian Health Services Research Institute, Sydney Business School, University of Wollongong, Room 255, Building 40, Wollongong, NSW, 3522, Australia. Simon_Eckermann@uow.edu.au
authors.forename: Simon
authors.initials: S
authors.lastname: Eckermann
authors.forename: Andrew R
authors.initials: AR
authors.lastname: Willan
mesh_terms: D020811:Biomedical Technology / Q000191:economics; D003299:Cooperative Behavior; D003657:Decision Making; D004059:Diffusion of Innovation; D004345:Drug Industry / Q000191:economics / Q000458:organization & administration*; D006801:Humans; D007258:Informed Consent; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods*; D012107:Research Design; D035842:Research Subjects / Q000523:psychology; D020414:Risk Sharing, Financial; D057170:Translational Research, Biomedical / Q000191:economics / Q000458:organization & administration