Integrating Personalized Medicine in the Canadian Environment: Efforts Facilitating Oncology Clinical Research

Abstract

There is currently a rapid evolution of clinical practices based on the introduction of patient stratification and molecular diagnosis that is likely to improve health outcomes. Building on a strong research base, complemented by strong support from clinicians and health authorities, the oncology field is at the forefront of this evolution. Yet, clinical research is still facing many challenges that need to be addressed in order to conduct necessary studies and effectively translate medical breakthroughs based on personalized medicine into standards of care. Leveraging its universal health care system and on resources developed to support oncology clinical research, Canada is well positioned to join the international efforts deployed to address these challenges. Available resources include a broad range of structures and funding mechanisms, ranging from direct clinical trial support to post-marketing surveillance. Here, we propose a clinical model for the introduction of innovation for precision medicine in oncology that starts with patients' and clinicians' unmet needs to initiate a cycle of discovery, validation, translation and sustainability development.

Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options

“…– Network of Centres of Excellence (academia, industry, government and non-profit organisations) [ 44 ]…”

“…– Operationalisation and streamlining of research are made on a national level, while healthcare decisions are made within provincial boundaries [ 44 ]…”

“…Barriers to financing research in PM were identified that related to the discordance between research prioritisation decisions on national and local levels [ 44 ] (Table 3 ), legal, intellectual property rights and privacy/ethics issues (such as lack of harmonisation of legal and ethical guidelines concerning data and sample sharing, as well as licensing concerns which require dedicated policies to help overcome them) [ 45 , 48 ]. Other reported barriers included the lack of strong links between potential industry and academic partners [ 48 ] and performance requirements focused on direct practical applicability rather than scientific advancement [ 30 ].…”

A survey of experts on personalized medicine landscape in European Union and China

“…It depends, also, on the level of discordance between research prioritization at national or international agenda. The latter, alongside with lack of harmonization of legal and ethical guidelines are considered by the experts as the main barriers to financing research in PM [ 17 , 18 ]. Healthcare systems have fragmented legislations and PM policies and programmes vary significantly among countries.…”

Challenges and solutions to system-wide use of precision oncology as the standard of care paradigm

“…Although public-private financing agreements (Polychronakos, 2012 ; Power et al, 2014 ) and performance-based reimbursement (De Souza et al, 2012 ) mechanisms were suggested as potential strategies (Koleva-Kolarova et al, 2022 ), the successful implementation of these strategies faced various issues. Among these, the disconnect between academic and private sectors (Gurwitz et al, 2009 ), the misalignment in research priorities nationally and internationally (Syme et al, 2015 ) as well as the ethical and legal issues surrounding data and sample sharing (Vis et al, 2017 ). Other issues revolve around generating outcome data and the inability to implement risk-sharing agreements across different healthcare systems, compounded with the health technology assessment frameworks, which are not fit to the uncertainty of precision oncology interventions (Regier et al, 2022 ).…”