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. 2020 Oct 16;7:582634. doi: 10.3389/fmed.2020.582634

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Copyright © 2020 Ofori-Asenso, Hallgreen and De Bruin.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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Perspective of health technology assessment (HTA) assessors and regulators regarding areas where alignment in evidentiary requirement could occur*. (A) Acceptable primary end point. (B) Inclusion of active comparator arm in the trial. (C) Use of patient reported outcomes. (D) Use of health-related quality of life measures. (E) Choice and use of surrogate measures. (F) Criteria considered in choice of comparator: therapeutic. (G) Use of subgroup analyses. (H) Inclusion and choice of secondary efficacy parameters. (I) Definition of unmet medical need. (J) Use of biomarkers to monitor patient outcomes. HTA, health technology assessment. *Graph produced by author using data from Wang et al. (25) in which a questionnaire-based survey was conducted among regulators (n = 7) and HTA agencies (n = 8) between August and September 2016.