the
cancer
collab
orative
lecollab
oratoire
cancer
The COVID19 pandemic has also been a major catalyst for innovation, resulting in unprecedented transformation and adoption of digital health and process innovations. In just a few months, the COVID19 crisis brought about years of change in the way companies in all sectors and regions do business, accelerating digitization of customer and supply chain interactions, as well as internal operations.35a The COVID19 pandemic has dramatically transformed the world we live in, affecting every aspect of our lives, including the way we work, learn, and interact with others. During this challenging time, disruptive innovations have played a crucial role in enabling us to adapt to this new normal. These technologies have revolutionized the way we communicate, access healthcare, and conduct business, allowing us to stay connected and productive while staying safe and socially distant. From remote work and virtual education to telemedicine and e-commerce, disruptive innovations have had a profound impact on our daily lives during the pandemic.
DIGITAL TRANSFORMATION
The digital transformation has been accelerated by the pandemic and suggests that it could continue to accelerate beyond the current recovery. Growing evidence shows that the pandemic has pushed firms in all sectors to overhaul their business models more aggressively than planned. An unprecedented catalyst for digital transformations across all sectors, as organizations sought to adapt to the new reality of remote work, social distancing, and reduced physical interactions. From healthcare to education, entertainment to retail, and finance to manufacturing, the pandemic has accelerated the adoption of innovative digital technologies that have fundamentally changed the way we live, work, and interact with each other. These digital transformations have not only helped businesses and organizations survive the pandemic but have also paved the way for a more connected, efficient, and resilient future.
The slow adoption of innovative health technologies prior to the pandemic can be attributed to a combination of disparate regulations, prolonged procurement processes, and poor access to funding that have prevented numerous enterprises from introducing digital innovations to revolutionize healthcare. This underscores the unhurried pace at which the commercialization of health tech had been unfolding in Canada.
DIGITAL HEALTH
The pandemic has led to considerable growth of the digital health industry in Canada, with jurisdictions removing bureaucracy that had impeded digital innovation. COVID19 forced both providers and regulatory bodies to turn to alternative ways of providing healthcare while limiting exposure to the virus. This has led to reduced bureaucracy around procurement, privacy and security, and billing codes to support payment for virtual care. Within weeks of the onset of the pandemic, virtual care, through the use of telephone and video visits, rose from less than 2% of all ambulatory visits at the start of 2020 to as high as 70% by mid May of the same year.35
Virtual care is a component of digital health, but important distinctions exist between digital health and virtual care. Digital health is defined as “the use of information technology/electronic communication tools, services and processes to deliver healthcare services or to facilitate better health.” While virtual care is “any interaction between patients and/or members of their circle of care, occurring remotely, using any forms of communication or information technologies.” Virtual care is a subset of digital health that includes provision of care over many media, including video, audio, and asynchronous messaging.35A Digital health also includes giving patients ownership of their personal health data and ensuring data interoperability across Canada.
Digital health is an increasingly essential component of a high performing healthcare system. Digital health care technologies promise benefits across Canada’s public health care system including cancer care. However, digital health innovation is relatively nascent in cancer care, which represents the fastest growing area of healthcare spending. Opportunities for digital health innovation in oncology include patient facing technologies that improve patient experience, safety, and patient clinician interactions; clinician facing technologies that improve their ability to diagnose pathology and predict adverse events; and quality of care and research infrastructure to improve clinical workflows, documentation, decision support, and clinical trial monitoring.36
According to the government of canada’s website ‘policymakers should enable public health care providers to best leverage the forces of competition. By ensuring that providers can adopt the newest innovations, the Canadian health care system can foster the development of the next generation of digital products and services. Such procompetitive policies will allow health care providers to offer the best quality care to their patients, regardless of whether it is delivered through a digital service or an in person visit. To foster competition in the digital future, Canada’s public health care policy needs to be modernized. When policymakers adapt rules, it is important that health care providers are given the flexibility to choose the tool or method of care that is most appropriate. In turn, this will allow providers to take advantage of competition in driving investments in innovation. This leads to better patient outcomes, lower costs, and a more promising future for the Canadian public health care system.’37 Despite the federal government's acknowledgment of the critical importance of digital health, the current, fragmented, provincial approach to health care creates barriers to the efficient procurement of technologies, interoperability, and data sharing, hindering actual innovation. This heavily siloed system not only disadvantages the healthcare system and Canadian digital health companies but also patients who depend on lifesaving innovations and quality of life improvements offered by these technologies in a growing global digital health industry.
The rapid shift towards digital healthcare has implications for healthcare systems in Canada, including the potential to improve the efficiency and quality of care, reduce costs, and enhance patient outcomes. However, the widespread adoption of digital technologies requires significant investments in infrastructure, training, and governance.
In addition, the shift towards digital healthcare may exacerbate existing health inequalities, as patients who lack access to technology or have low health literacy may be left behind. Healthcare systems must address these challenges to ensure that digital technologies benefit all patients and improve health equity.
ROLLING REVIEWS
The need for increased regulatory agility was recognized during the pandemic, and Health Canada has recognized this need as an opportunity to modernize and streamline its regulatory processes. A rolling review is a regulatory process in which health authorities review data from clinical trials for a vaccine or treatment as it becomes available, rather than waiting for the full data set to be submitted at the end of the trial. This allows regulators to start the review process early and speed up the overall timeline for approval.
The operational pressures of the pandemic have necessitated rapid decision making and flexibility, and regulatory agencies around the world have responded by offering new ways of working to help combat the pandemic. The rolling review procedure is an important and successful example of this, allowing Health Canada to expedite the regulatory approval process for COVID19 vaccines and treatments while still ensuring that they meet rigorous safety and efficacy standards.
The success of the rolling review process during the pandemic has also demonstrated the potential for greater regulatory agility in the future. Health Canada has indicated that it plans to build on the lessons learned during the pandemic and to continue to modernize its regulatory processes to better meet the needs of patients and industry stakeholders.
CERTAIN UNCERTAINTY
During the pandemic, Canadian regulators, health technology assessment (HTA) bodies, and payors have demonstrated a willingness to embrace uncertainty and adopt innovative strategies to respond to unforeseen challenges. Health Canada implemented expedited review processes for certain medical devices and drugs to
ensure timely access to critical therapies.
On March 30, 2020, Health Canada pursuant to subsection 30.1(1)38 of the Food and Drugs Act made the annexed Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID19, which addressed the exceptional importation of drugs, medical devices, and foods for a special dietary purpose (e.g., infant formula) in relation to COVID19. The March 30 Interim Order allowed certain drugs and devices that do not fully meet regulatory requirements to be imported and sold in Canada. In September 2021 new amendments to the Food and Drug Regulations in Canada were published to create a permanent pathway for the exceptional importation and sale of foreign authorized drugs and medical devices into Canada in response to a shortage. These regulations entered into force on March 2, 2022.
As part of the government’s broad response to the pandemic, Health Canada introduced innovative and agile regulatory measures.39 Adaptive regulatory pathways that allowed for the approval of treatments and vaccines based on limited clinical data were implemented, with a commitment from manufacturers to continue to collect and analyze data as it became available. This approach allowed for quicker access to potentially lifesaving treatments and vaccines while still ensuring the ongoing evaluation of their safety and efficacy.40
Health Canada also utilized international data and evidence from other regulatory agencies to inform their decision making, rather than relying solely on their own data. This allowed for a more efficient review process and reduced duplication of efforts. Through the European Medicines Agency's (EMA) Opening our Procedures at EMA to Non EU authorities (OPEN) project, Health Canada was able to participate in the EMA’s assessment of COVID19 related medicinal products, including vaccines. And through the International Coalition of Medicines Regulatory Authorities (ICMRA) a global organization that brings together regulatory authorities from around the world to collaborate and share information on the development and regulation of medicines, including vaccines and treatments for COVID19. With the aim to expedite and streamline the development, authorization, and availability of COVID19 treatments and vaccines worldwide. ICMRA members are also focused on improving regulatory processes and decision making to enhance the efficiency and effectiveness of the regulatory system. This includes sharing best practices, developing new regulatory tools and approaches, and collaborating with other stakeholders to address regulatory challenges related to COVID19 and other health threats.41
Canadian decision makers relied on a range of tools and approaches, including scenario planning, modelling, data analysis, and expert consultations to mitigate the unprecedented levels of uncertainty, complexity, and ambiguity brought on by the pandemic. These tools and approaches have helped decision makers to better understand the potential consequences of different policy options and to identify the most effective strategies for controlling the spread of COVID19 while minimizing harm to individuals and the economy.
In addition, decision makers in Canada have sought to engage the public and other stakeholders in the decision making process to ensure that their decisions are informed by diverse perspectives and the latest scientific evidence. This has included regular updates and briefings from government officials, consultations with key stakeholders, and open forums for public input. (see CanCovid above)
In the world of healthcare, uncertainty in regulatory, HTA and reimbursement processes is a certainty. These decisions often involve complex and evolving criteria. Effective communication is critical in navigating this uncertainty and minimizing the risk of ineffectiveness. Lacking or poorly received communication amongst stakeholders can lead to misunderstanding, mistrust, and delays in decision making, which ultimately impacts patients. To avoid ineffectiveness, it is essential for stakeholders to engage in transparent and open communication, working in collaboration towards a shared goal of improving patient outcomes in a resilient and sustainable health system.
VALUE BASED HEALTHCARE
The COVID19 pandemic has provided healthcare systems with an opportunity to deliver better value to patients by adopting a value based healthcare approach. Despite the challenges encountered during the pandemic, healthcare systems have made significant strides towards establishing a patient centered and data driven model for delivering healthcare. They have defined centralized goals based on patient outcomes and collaborated with various stakeholders, such as policymakers, providers, payors, and life science companies. The pandemic has also validated the key features of value based healthcare, which were previously deemed too complex to implement. Through a targeted approach and focus on outcomes, healthcare systems have improved how they manage the disease and have conducted successful vaccination programs.42
The pandemic has proven that delivering value based healthcare is not abstract or challenging but can quickly succeed when stakeholders align towards the common goal of achieving improved patient outcomes. Healthcare system stakeholders can build on this momentum by exploiting the lessons from the COVID19 response and transforming their organizations and healthcare models to achieve higher value care strategically and comprehensively.
CLINICAL TRIALS
Like every other aspect of healthcare, clinical trials have also been profoundly impacted by the pandemic, leading to widespread disruption and delays in ongoing clinical trials. The COVID19 pandemic has prominently highlighted many fundamental issues that exist in clinical trial research under the current system and its incentive structures, and data sharing. The problems and limitations that have existed for clinical trial research have arguably become much more visible, spurring a wave of innovation and adoption of innovative technologies and trial designs in response to the pandemic. The pandemic also highlighted the extent to which our current site based clinical trial model is costly, limits populations served and burdens trial participants.
One of the most significant changes to clinical trial design in response to the pandemic has been the widespread adoption of virtual visits and remote monitoring. With many clinical trial sites shut down or operating at reduced capacity, virtual visits and remote monitoring have become essential tools for maintaining study integrity and participant safety. These technologies allow patients to participate in clinical trials from the comfort of their own homes, reducing the need for in person visits (and minimizing the risk of COVID19 exposure). The adoption of decentralized trial models has also been implemented, this allowed participants to receive study treatments and assessments in their own homes or at local healthcare facilities. These models can be particularly useful for studies that require frequent monitoring or administration of study treatments, as they reduce the need for participants to travel to study sites. Decentralized trials can also be more cost effective than traditional trials. The importance of patient centricity in clinical research, which was widely recognized during the pandemic has led to the adoption of novel approaches to patient engagement and communication. With many participants hesitant to visit hospitals or clinics due to the risk of COVID19 exposure, clinical trial sponsors have had to be more proactive in their communication with participants. This has included providing clear and timely updates on study progress and safety, as well as offering flexible study timelines and procedures to accommodate participant needs.
Regulatory authorities have also had to adapt to the pandemic related changes in clinical research. In many cases, they have provided guidance on remote monitoring and data collection, as well as expediting review of COVID19 related treatments and vaccines. These adaptations have helped to ensure that clinical research can continue despite the pandemic related challenges.43
The adoption of new technologies and trial designs in response to the pandemic has the potential to transform the field of clinical research in the long term. Drawing on the lessons learned from COVID19 pandemic to describe how the research community has responded to the outbreak and the need to embrace coordination
and collaboration instead of competition in medical and public health research. Decentralized trial models and virtual visits could make clinical research more accessible and patient friendly, particularly for participants who live in remote or underserved areas. Remote monitoring and data collection could also lead to more efficient and cost effective clinical trials.
