Clinical biomarker innovation: when is it worthwhile?

Contains fulltext : 208980.pdf (publisher's version ) (Open Access

For the good of society: using, expanding and organizing the evaluation toolbox of health technologies under development

Contains fulltext : 212440.pdf (publisher's version ) (Open Access)Radboud University, 10 december 2019Promotor : Wilt, G.J. van der Co-promotores : Grutters, J.P.C., Tummers, M.J.G.M

Early Assessment of Proof-of-Problem to Guide Health Innovation

Contains fulltext : 204566.pdf (publisher's version ) (Closed access

Exploring the risk-reward balance in focal therapy for prostate cancer-a contribution to the debate

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Value Assessment Frameworks for HTA Agencies: The Organization of Evidence-Informed Deliberative Processes

Priority setting in health care has been long recognized as an intrinsically complex and value-laden process. Yet, health technology assessment agencies (HTAs) presently employ value assessment frameworks that are ill fitted to capture the range and diversity of stakeholder values and thereby risk compromising the legitimacy of their recommendations. We propose "evidence-informed deliberative processes" as an alternative framework with the aim to enhance this legitimacy. This framework integrates two increasingly popular and complementary frameworks for priority setting: multicriteria decision analysis and accountability for reasonableness. Evidence-informed deliberative processes are, on one hand, based on early, continued stakeholder deliberation to learn about the importance of relevant social values. On the other hand, they are based on rational decision-making through evidence-informed evaluation of the identified values. The framework has important implications for how HTA agencies should ideally organize their processes. First, HTA agencies should take the responsibility of organizing stakeholder involvement. Second, agencies are advised to integrate their assessment and appraisal phases, allowing for the timely collection of evidence on values that are considered relevant. Third, HTA agencies should subject their decision-making criteria to public scrutiny. Fourth, agencies are advised to use a checklist of potentially relevant criteria and to provide argumentation for how each criterion affected the recommendation. Fifth, HTA agencies must publish their argumentation and install options for appeal. The framework should not be considered a blueprint for HTA agencies but rather an aspirational goal-agencies can take incremental steps toward achieving this goal