Marc Clausen1, Chloe Mighton1, Ruhi Kiflen1, Agnes Sebastian1, Wei Fang Dai1, Rebecca E Mercer1, Jaclyn M Beca1, Wanrudee Isaranuwatchai1, Kelvin K W Chan1, Yvonne Bombard2. 1. Li Ka Shing Knowledge Institute (Clausen, Mighton, Sebastian, Isaranuwatchai, Bombard), St. Michael's Hospital, Unity Health; Institute of Health Policy, Management and Evaluation (Mighton, Sebastian, Beca, Isaranuwatchai, Bombard), University of Toronto; Canadian Cancer Society (Kiflen); Cancer Care Ontario (Dai, Mercer, Beca, Chan), Ontario Health; Canadian Centre for Applied Research in Cancer Control (Dai, Mercer, Beca, Isaranuwatchai, Chan); Sunnybrook Health Sciences Centre (Chan), Toronto, Ont. 2. Li Ka Shing Knowledge Institute (Clausen, Mighton, Sebastian, Isaranuwatchai, Bombard), St. Michael's Hospital, Unity Health; Institute of Health Policy, Management and Evaluation (Mighton, Sebastian, Beca, Isaranuwatchai, Bombard), University of Toronto; Canadian Cancer Society (Kiflen); Cancer Care Ontario (Dai, Mercer, Beca, Chan), Ontario Health; Canadian Centre for Applied Research in Cancer Control (Dai, Mercer, Beca, Isaranuwatchai, Chan); Sunnybrook Health Sciences Centre (Chan), Toronto, Ont. yvonne.bombard@utoronto.ca.
Abstract
BACKGROUND: Real-world evidence (RWE) can provide postmarket data to inform whether funded cancer drugs yield expected outcomes and value for money, but it is unclear how to incorporate RWE into Canadian cancer drug funding decisions. As part of the Canadian Real-World Evidence Value for Cancer Drugs (CanREValue) Collaboration, this study aimed to explore stakeholder perspectives on the current state of RWE in Canada to inform a Canadian framework for use of RWE in cancer drug funding decisions. METHODS: This was a qualitative descriptive study. Qualitative semistructured interviews were conducted from April to July 2018. Participants were Canadian and international stakeholders who had experience with RWE and drug funding decision-making. Thematic analysis was used to analyze data. RESULTS: Thirty stakeholders participated in the study. Five themes were identified. Stakeholders indicated that RWE had value in cancer drug funding decisions. However, a cultural shift is needed to adopt RWE in decision-making. Further, the Canadian infrastructure for real-world data is currently inadequate for decision-making, and there is a need for committed investment in building capacity to collect and analyze RWE. Finally, there is a need for increased collaboration among key stakeholders. INTERPRETATION: The findings of this study suggest that if RWE is to be used in drug funding decisions, there is a need for a cultural shift, improved data infrastructure, committed investment in capacity building and increased stakeholder collaboration. Together with local stakeholder engagement, application of these findings may contribute to optimizing implementation of RWE. Copyright 2020, Joule Inc. or its licensors.
BACKGROUND: Real-world evidence (RWE) can provide postmarket data to inform whether funded cancer drugs yield expected outcomes and value for money, but it is unclear how to incorporate RWE into Canadian cancer drug funding decisions. As part of the Canadian Real-World Evidence Value for Cancer Drugs (CanREValue) Collaboration, this study aimed to explore stakeholder perspectives on the current state of RWE in Canada to inform a Canadian framework for use of RWE in cancer drug funding decisions. METHODS: This was a qualitative descriptive study. Qualitative semistructured interviews were conducted from April to July 2018. Participants were Canadian and international stakeholders who had experience with RWE and drug funding decision-making. Thematic analysis was used to analyze data. RESULTS: Thirty stakeholders participated in the study. Five themes were identified. Stakeholders indicated that RWE had value in cancer drug funding decisions. However, a cultural shift is needed to adopt RWE in decision-making. Further, the Canadian infrastructure for real-world data is currently inadequate for decision-making, and there is a need for committed investment in building capacity to collect and analyze RWE. Finally, there is a need for increased collaboration among key stakeholders. INTERPRETATION: The findings of this study suggest that if RWE is to be used in drug funding decisions, there is a need for a cultural shift, improved data infrastructure, committed investment in capacity building and increased stakeholder collaboration. Together with local stakeholder engagement, application of these findings may contribute to optimizing implementation of RWE. Copyright 2020, Joule Inc. or its licensors.
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