Tania Bubela
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View article: Patient and population impacts of multigene panel and pembrolizumab coverage in metastatic melanoma
Patient and population impacts of multigene panel and pembrolizumab coverage in metastatic melanoma Open
Background Targeted treatment or immunotherapy may yield increased, durable responses for melanoma patients. Whether patient-level benefits translate to population health is unknown. This study sought to estimate patient and population imp…
View article: How life-cycle real-world evidence can bridge evidentiary gaps in precision oncology
How life-cycle real-world evidence can bridge evidentiary gaps in precision oncology Open
Precision oncology uses omics-based diagnostic technologies to inform histology-agnostic cancer treatment. To date, health system implementation remains limited owing to high uncertainty in regulatory and reimbursement evidence submissions…
View article: Putting the substance in substantial evidence: an evidence-based approach to flexible drug regulation
Putting the substance in substantial evidence: an evidence-based approach to flexible drug regulation Open
For new drugs or indications, substantial evidence of clinical effectiveness is required for market authorization. In most jurisdictions, substantial evidence is not explicitly defined. Health regulators exercise discretion and are increas…
View article: Delphi-driven consensus definition for mesenchymal stromal cells and clinical reporting guidelines for mesenchymal stromal cell–based therapeutics
Delphi-driven consensus definition for mesenchymal stromal cells and clinical reporting guidelines for mesenchymal stromal cell–based therapeutics Open
By applying a Delphi method to establish a consensus definition for MSCs and reporting guidelines for MSC-based clinical trials, this work represents a significant advance in improving transparency and reproducibility in the conduct and re…
View article: “I Just Assumed This Was Already Being Done”: Canadian Patient Preferences for Enhanced Data Sharing for Precision Oncology
“I Just Assumed This Was Already Being Done”: Canadian Patient Preferences for Enhanced Data Sharing for Precision Oncology Open
PURPOSE In Canada, health data are siloed, slowing bioinnovation and evidence generation for personalized cancer care. Secured data-sharing platforms (SDSPs) can enable data analysis across silos through rapid concatenation across trial an…
View article: Precision medicine: drowning in a regulatory soup?
Precision medicine: drowning in a regulatory soup? Open
As US President Barack Obama noted in his 2015 State of the Union address, precision medicine promises to deliver ‘the right treatments, at the right time, every time to the right person’ which ‘gives us one of the greatest opportunities f…
View article: From Patchwork to Framework: Expert Interview Insights on Establishing a Bioethics Council for Canada
From Patchwork to Framework: Expert Interview Insights on Establishing a Bioethics Council for Canada Open
Canada has historically relied on a system of ad hoc committees for ethical guidance on public health and science policy, unlike the more centralized approach of more than 140 countries worldwide. Here, drawing on interviews with leaders a…
View article: Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic
Key challenges in bringing CRISPR-mediated somatic cell therapy into the clinic Open
Genome editing using clustered regularly interspersed short palindromic repeats (CRISPR) and CRISPR-associated proteins offers the potential to facilitate safe and effective treatment of genetic diseases refractory to other types of interv…
View article: Canadian newspaper coverage on harm reduction featuring bereaved mothers: A mixed methods analysis
Canadian newspaper coverage on harm reduction featuring bereaved mothers: A mixed methods analysis Open
A growing body of evidence suggests that news media which includes a sympathetic portrayal of a mother bereaved by substance use can increase public support for harm reduction initiatives. However, the extent to which such news media cover…
View article: Asynchronous online focus groups for research with people living with amyotrophic lateral sclerosis and family caregivers: usefulness, acceptability and lessons learned
Asynchronous online focus groups for research with people living with amyotrophic lateral sclerosis and family caregivers: usefulness, acceptability and lessons learned Open
Background People with amyotrophic lateral sclerosis (ALS) face disability- and travel-related barriers to research participation. We investigate the usefulness and acceptability of asynchronous, online focus groups (AOFGs) for research in…
View article: Public Biological Databases and the Sui Generis Database Right
Public Biological Databases and the Sui Generis Database Right Open
The sui generis database right is an intellectual property right created in the European Union to stimulate investment in the curation of databases. Since its inception, communities engaged in research and development efforts have question…
View article: Use and misuse of research: Canada’s response to covid-19 and its health inequalities
Use and misuse of research: Canada’s response to covid-19 and its health inequalities Open
View article: How Canada’s decentralised covid-19 response affected public health data and decision making
How Canada’s decentralised covid-19 response affected public health data and decision making Open
Canada's public health system was reformed after its 2003 severe acute respiratory syndrome (SARS) outbreak, which was the worst outside of Asia with 438 cases and 44 deaths. 1 Ensuing national and provincial inquiries led to the creation …
View article: What do people affected by amyotrophic lateral sclerosis want from health communications? Evidence from the <scp>ALS</scp> Talk Project
What do people affected by amyotrophic lateral sclerosis want from health communications? Evidence from the <span>ALS</span> Talk Project Open
Introduction/Aims Health communication is central to effective, supportive amyotrophic lateral sclerosis (ALS) clinical care. Guidance for ALS communication is limited, focuses on diagnosis disclosure, and frequently relies on expert conse…
View article: Index
Index Open
This comprehensive Research Handbook explores empirical legal studies of intellectual property law. It covers research from four continents and offers unique conclusions to aid in the creation and understanding of policies and legislation.
View article: Lessons from Canada’s notice of compliance with conditions policy for the life-cycle regulation of drugs
Lessons from Canada’s notice of compliance with conditions policy for the life-cycle regulation of drugs Open
Innovative health technologies are not well regulated under current pathways, leading regulators to adopt contextual, life-cycle regulatory models, which authorize drugs based on earlier clinical evidence subject to the conduct of post-mar…
View article: Should Canada adopt managed access agreements in Canada for expensive drugs?
Should Canada adopt managed access agreements in Canada for expensive drugs? Open
Drugs are increasingly authorized based on less mature evidence, leaving payors faced with significant clinical and cost-effectiveness uncertainties. As a result, payors must often choose between reimbursing a drug that may not turn out to…
View article: Do-It-Yourself and Commercial Automated Insulin Delivery Systems in Type 1 Diabetes: An Uncertain Area for Canadian Health-care Providers
Do-It-Yourself and Commercial Automated Insulin Delivery Systems in Type 1 Diabetes: An Uncertain Area for Canadian Health-care Providers Open
© This manuscript version is made available under the CC-BY-NC-ND 4.0 license https://creativecommons.org/licenses/by-nc-nd/4.0/. Deposited by shareyourpaper.org and openaccessbutton.org. We've taken reasonable steps to ensure this content…
View article: A perspective on life-cycle health technology assessment and real-world evidence for precision oncology in Canada
A perspective on life-cycle health technology assessment and real-world evidence for precision oncology in Canada Open
View article: Amyotrophic lateral sclerosis (ALS) health charities are central to ALS care: perspectives of Canadians affected by ALS
Amyotrophic lateral sclerosis (ALS) health charities are central to ALS care: perspectives of Canadians affected by ALS Open
ALS Societies provide patients with critical practical, informational, and emotional support and play an overarching role as patient/research navigators. Patient-centred outcomes support patient referral to ALS Societies. Communication abo…
View article: “I have such a hard time hitting myself, I thought it’d be easier”: perspectives of hospitalized patients on injecting drugs into vascular access devices
“I have such a hard time hitting myself, I thought it’d be easier”: perspectives of hospitalized patients on injecting drugs into vascular access devices Open
View article: Covid-19 threat and coping: application of protection motivation theory to the pandemic experiences of people affected by amyotrophic lateral sclerosis
Covid-19 threat and coping: application of protection motivation theory to the pandemic experiences of people affected by amyotrophic lateral sclerosis Open
View article: CAPTURE ALS: the comprehensive analysis platform to understand, remedy and eliminate ALS
CAPTURE ALS: the comprehensive analysis platform to understand, remedy and eliminate ALS Open
The absence of disease modifying treatments for amyotrophic lateral sclerosis (ALS) is in large part a consequence of its complexity and heterogeneity. Deep clinical and biological phenotyping of people living with ALS would assist in the …
View article: The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada
The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada Open
Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval…
View article: Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness
Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness Open
International drug regulators use conditional drug approval mechanisms to facilitate faster patient access to drugs based on a lower evidentiary standard typically required of drug approvals. Faster and earlier access is justified by limit…
View article: Legal and Regulatory Enablers and Barriers to Conditional Regulatory and Reimbursement Alternatives in Canadian Health Systems
Legal and Regulatory Enablers and Barriers to Conditional Regulatory and Reimbursement Alternatives in Canadian Health Systems Open
View article: Communication About End of Life for Patients Living With Amyotrophic Lateral Sclerosis: A Scoping Review of the Empirical Evidence
Communication About End of Life for Patients Living With Amyotrophic Lateral Sclerosis: A Scoping Review of the Empirical Evidence Open
Background: Communication about end of life, including advance care planning, life-sustaining therapies, palliative care, and end-of-life options, is critical for the clinical management of amyotrophic lateral sclerosis patients. The empir…
View article: ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update
ISSCR Guidelines for Stem Cell Research and Clinical Translation: The 2021 update Open
View article: Let’s do better: public representations of COVID-19 science
Let’s do better: public representations of COVID-19 science Open
COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflict…
View article: Identifying and understanding factors that affect the translation of therapies from the laboratory to patients: a study protocol
Identifying and understanding factors that affect the translation of therapies from the laboratory to patients: a study protocol Open
Background: The process of translating preclinical findings into a clinical setting takes decades. Previous studies have suggested that only 5-10% of the most promising preclinical studies are successfully translated into viable clinical a…