Open science precision medicine in Canada: Points to consider

Current Oncology, 2022

Canada's healthcare system, like others worldwide, is immersed in a process of evolution, attempting to adapt conventional frameworks of health technology assessment (HTA) and funding models to a new landscape of precision medicine in oncology. In particular, the need for real-world evidence in Canada is not matched by the necessary infrastructure and technologies required to integrate genomic and clinical data. Since healthcare systems in many developed nations face similar challenges, we adopted a solutions-based approach and conducted a search of worldwide programs in personalized medicine, with an emphasis on precision oncology. This search strategy included review articles published between 1 January 2016 and 1 March 2021 and hand-searches of their reference lists for relevant publications back to 1 December 2005. Thirty-nine initiatives across 37 countries in Europe, Australasia, Africa, and the Americas had the potential to lead to real-world data (RWD) on the clinical utility of oncology biomarkers. We highlight four initiatives with helpful lessons for Canada: Genomic Medicine France 2025, UNICANCER, the German Medical Informatics Initiative, and CANCER-ID. Among the 35 other programs evaluated, the main themes included the need for collaboration and systems to support data harmonization across multiple jurisdictions. In order to generate RWD in precision oncology that will prove acceptable to HTA bodies, Canada must take a national approach to biomarker strategy and unite all stakeholders at the highest level to overcome jurisdictional and technological barriers.

Nature Genetics, 2019

The Nordic region, comprising primarily Denmark, Estonia, Finland, Iceland, Norway and Sweden, has many of the necessary characteristics for being at the forefront of genome-based precision medicine. These include egalitarian and universal healthcare, expertly curated patient and population registries, biobanks, large population-based prospective cohorts linked to registries and biobanks, and a widely embraced sense of social responsibility that motivates public engagement in biomedical research. However, genome-based precision medicine can be achieved only through coordinated action involving all actors in the healthcare sector. Now is an opportune time to organize scientists in the Nordic region, together with other stakeholders including patient representatives, governments, pharmaceutical companies, academic institutions and funding agencies, to initiate a Nordic Precision Medicine Initiative. We present a roadmap for how this organization can be created. The Initiative should facilitate research, clinical trials and knowledge transfer to meet regional and global health challenges.

The Hastings Center report, 2017

The United States' ambitious Precision Medicine Initiative proposes to accelerate exponentially the adoption of precision medicine, an approach to health care that tailors disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It aims to achieve this by creating a cohort of volunteers for precision medicine research, accelerating biomedical research innovation, and adopting policies geared toward patients' empowerment. As strategies to implement the PMI are formulated, critical consideration of the initiative's ethical and sociopolitical dimensions is needed. Drawing on scholarship of nationalism and democracy, we discuss the PMI's construction of what we term "genomic citizenship"; the possible normative obligations arising therefrom; and the ethical, legal, and social challenges that will ensue. Although the PMI is a work in progress, discussion of the existing and emerging issues can facilitate the de...

European journal of cancer (Oxford, England : 1990), 2017

The increasing number of drugs targeting specific proteins implicated in tumourigenesis and the commercial promotion of relatively affordable genome-wide analyses has led to an increasing expectation among patients with cancer that they can now receive effective personalised treatment based on the often complex genomic signature of their tumour. For such approaches to work in routine practice, the development of correspondingly complex biomarker assays through an appropriate and rigorous regulatory framework will be required. It is becoming increasingly evident that a re-engineering of clinical research is necessary so that regulatory considerations and procedures facilitate the efficient translation of these required biomarker assays from the discovery setting through to clinical application. This article discusses the practical requirements and challenges of developing such new precision medicine strategies, based on leveraging complex genomic profiles, as discussed at the Innovat...

Journal of Law and the Biosciences, 2016

and Director of the Centre for Law and Genetics. The broad theme of her research is the regulation of biotechnology and human genomics and genetics. She is particularly interested in the commercialization of genetic knowledge and patenting of

Frontiers in Public Health

Ethnicity & disease, 2018

Patient and community engagement in under-resourced communities is a key issue for precision medicine research. We report proceedings from a community-academic partnered conference in Los Angeles to promote community understanding of precision medicine and generate engagement recommendations. Planning group review of planning, presentations, and audience discussions from facilitator notes and participant survey data from a one-day conference. Community-academic planning broadened community participation and presentations. More than 80% of survey participants indicated they would participate in the national precision medicine initiative, and most were willing to share diverse sources of data. Discussions identified trust concerns related to historical research abuses, data privacy, potential effects of findings on health care, personal safety, research procedures, the time-frame for benefit, and confusion about different initiatives. Concerns were balanced by belief in science to imp...

Public Health Genomics

Introduction: Precision medicine research investigates the differences in individuals’ genetics, environment, and lifestyle to tailor health prevention and treatment options as part of an emerging model of health care delivery. Advancing precision medicine research will require effective communication across a wide range of scientific and health care disciplines and with research participants who represent diverse segments of the population. Methods: A multidisciplinary group convened over the course of a year and developed precision medicine research case examples to facilitate precision medicine research discussions with communities. Results: A shared definition of precision medicine research as well as six case examples of precision medicine research involving genetic risk, pharmacogenetics, epigenetics, the microbiome, mobile health, and electronic health records were developed. Discussion/Conclusion: The precision medicine research definition and case examples can be used as pl...

Briefings in bioinformatics, 2015

The 'precision medicine (systems medicine)' concept promises to achieve a shift to future healthcare systems with a more proactive and predictive approach to medicine, where the emphasis is on disease prevention rather than the treatment of symptoms. The individualization of treatment for each patient will be at the centre of this approach, with all of a patient's medical data being computationally integrated and accessible. Precision medicine is being rapidly embraced by biomedical researchers, pioneering clinicians and scientific funding programmes in both the European Union (EU) and USA. Precision medicine is a key component of both Horizon 2020 (the EU Framework Programme for Research and Innovation) and the White House's Precision Medicine Initiative. Precision medicine promises to revolutionize patient care and treatment decisions. However, the participants in precision medicine are faced with a considerable central challenge. Greater volumes of data from a wid...

Today's Esquire, 2022

The ultimate path that precision medicines will take is unclear, although it is already apparent that diseases that hitherto were classed as ‘untreatable’ can potentially be treated (and, in a few cases, are being treated). These conditions are genetic diseases and certain cancers. While scientific thinking has advanced and technologies have followed suit, the ethical issues that stem from these innovations are lagging. These ethical issues relate to privacy, data security, and law. To tailor treatments for patients requires the capture and analysis of vast amount of patient-centric data. However, doubts are being expressed as to how well-equipped global health systems are to handle such data and over the level of maturity that exists in terms of ethical and legal regulation. Sandle, T. (2022) Lagging Behind? Are Regulations Keeping Pace With The Precision Medicine Revolution?, Today’s Esquire, 14th November 2022 at: https://www.todaysesquire.com/2022/11/14/lagging-behind-are-regulations-keeping-pace-with-the-precision-medicine-revolution/