Real World Data (RWD) is information routinely collected by the health care system around health care encounters and clinical observations. Unlike data collected in the controlled environments of clinical trials, RWD is information collected in real world settings, using interventions and technologies that are currently available to patients or incorporated into standard care practices.
Real World Evidence (RWE) studies investigate the impact of an intervention or technology on health outcomes and resource utilization in clinical conditions outside of the controlled clinical trial setting. The evidence is generated from routinely collected health data to evaluate the safety, effectiveness, and value of newly introduced or existing health technologies and/or other interventions.
RWE is playing a growing role in technology adoption, as well as health policy and clinical practice decision-making, recognizing some of the limitations of traditional controlled clinical trials. Governments and health service providers are using RWE to improve health outcomes in priority areas, and to monitor the post-market safety and effectiveness of new or existing health technologies and innovations. This information is also being used to support coverage and procurement decisions, as well as to assess return on investment of public dollars. Additionally, clinicians are increasingly using this information in the development of clinical guidelines and decision-support tools, and, with quality RWE, technology developers may improve market access over time.
Quality RWE is used to greatly enhance the safety and efficacy of Alberta’s health care system. Alberta has one of the largest, most mature, detailed and comprehensive health system data depositories in Canada. As such, Alberta is poised to become a global leader in RWE generation. To realize this potential, the Universities of Alberta and Calgary, along with the Institute of Health Economics, have led the formation of the Alberta RWE Consortium. Consortium membership also includes Alberta Innovates, Alberta Health, Alberta Economic Development and Trade, and Alberta Health Services.
The Consortium engages key provincial stakeholders involved in RWE generation and utilization in order to advance provincial capabilities, ensure high-quality projects managed to timelines and budget, and (where capacity is limiting) help focus projects and provincial resources on joint priorities between sponsors and the province.
The Consortium is co-chaired by the Director, Health Technology Assessment Unit of the University of Calgary, the Assistant Dean, Health Outcomes of the University of Alberta, and the Executive Director and CEO of the Institute of Health Economics. Additional organizations that are members of the Consortium include the Government of Alberta (the Ministry of Health and the Ministry of Economic Development and Trade), Alberta Health Services, and Alberta Innovates.
The Consortium serves to significantly enhance the quality of Alberta RWE capabilities and evidence that is generated. It will ensure that the best pan-provincial teams are assembled and that research questions are feasible and the most informative, and will create peer review opportunities for quality assurance at all stages of a project. The Consortium also provides professional project management to support project delivery on time and within budget, with effective communication with sponsors throughout. Where capacity is limiting, the Consortium will engage in projects that represent areas of joint priority for sponsors and the province.
The Consortium is primarily concerned with projects that are evaluations of safety, effectiveness, and/or value of a technology or other intervention that is currently used in clinical practice (i.e., not an intervention being tested in a randomized controlled trial in a limited patient population).
Lack of Consortium involvement/support for an RWE project does not preclude an organization or individual from conducting RWE analyses utilizing Alberta data. Rather, the intent is that sponsors and those that generate RWE will seek out the support of the Consortium in the interest of accessing resources, expertise, processes, and data that will increase the quality of their RWE products. In addition, it is expected that, as the Consortium matures, its leadership of a project will constitute a marker of quality that will be valuable to those that utilize results to make decisions.
Study sponsors, be they industry, public sector, or not-for-profit organizations, will benefit from projects contracted with and managed by the Consortium as they will, by design, assemble the best pan-provincial team and implement SOPs that ensure high-quality analyses and reporting. Consortium-led projects are designed to produce evidence from robust data sources that is intended to provide assurances of high quality and rigour to those that utilize it for decision-making. Additionally, Consortium-led projects will have a KT component provincially to support implementation of evidence into policy and practice.
Those that produce RWE will benefit from working on a Consortium-led project as they will have access to supportive project and budget management services, streamlined contracting with industry and other sponsors, and opportunity for peer feedback on methodologies and analytic plans, analyses, and reports, with the intent to strengthen the evidence generated.
Alberta has the largest integrated health delivery system in Canada. Available data ranges from administrative to clinical, and covers a broad spectrum of data types, therapeutic areas, and health system sectors. A key first step in Consortium-led projects is a feasibility analysis in order to ensure that required linked data is available to support answering a project’s research question(s).
Albertans place a high value on their right to privacy and confidentiality. The province protects and controls health system data through a rigorous data-protection regulatory framework. Those working on Consortium-led projects (e.g., data custodians and researchers) are legally obligated to be in strict compliance with provincial and federal privacy legislation, as well as established organizational privacy and security policies. For more information about health data protection legislation please see the following resources/links:
- Provincial health data legislation in Alberta
- Health Information Act (HIA)– establishes the rules for the collection, use, disclosure, and protection of health information by custodians. It also provides individuals with a right of access to their health information, the right to request a correction or amendment to their health information, and oversight over the legislation.
- Health Information Regulation – provides additional rules for the collection, use, disclosure, and protection of health information by custodians.
- Alberta Electronic Health Record Regulation – details requirements for the Alberta Electronic Health Record, also known as Alberta Netcare.
- Designation Regulation – designates the research ethics boards approved for the purposes of Division 3 of the HIA.
- Alberta’s Queen’s Printer – the official source for copies of Alberta legislation, including the HIA and its regulations.
For more information please see: http://www.health.alberta.ca/about/Health-Information-Act.html
- Legislation and regulations guiding research access to real world data
For more information please see: https://www.albertahealthservices.ca/research/Page13995.aspx.
The Consortium supports researchers to strengthen the quality of RWE that is generated. Researchers working with the Consortium do not provide any patient-level, identifiable or non-identifiable data to industry or any other sponsor. Rather, the RWE generated and made available to sponsors will include aggregate analyses and summary statistics upon which conclusions can be derived. In doing so, no legislative processes will be bypassed – requests for data for use by research teams will be done through appropriate, secure channels in accordance with provincial privacy legislation. Data accessed by research teams working with the Consortium will be collected, used, disposed, and disclosed only according to strict legislation that preserve patient privacy.
Will the Consortium serve as a way to bypass regular checks and balances of the provincial health system with regard to data access?
No. Requests for data will be done through appropriate, secure channels in accordance with provincial privacy legislation. Data accessed by research teams working with the Consortium will be collected, used, disposed, and disclosed only according to strict legislation that preserve patient privacy. The Consortium is committed to maintaining the highest standards of conduct in the protection of the privacy and confidentiality of individuals’ personal and health information.
The first point of contact for organizations interested in conducting an RWE study involving the Consortium is the Secretariat, which is the Institute of Health Economics. Please email enquires to firstname.lastname@example.org