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Real World Evidence (RWE) 201 – Canada – Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making

RWE 201 – Canada – Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making


Health Canada released its position (May 2023) on the Canadian Agency for Drugs and Technologies in Health (CADTH) Guidance for Reporting Real-World Evidence (RWE) to Support Decision-making.

The CADTH RWE guidance, developed in collaboration with Health Canada and other stakeholders, aims to promote the use of high-quality real-world data (RWD) and RWE in drug development and regulatory decision-making. It also emphasizes the importance of transparent and comprehensive reporting of RWE studies to assess reliability and reproducibility.

While traditional clinical trials remain the primary source of evidence for regulatory decision-making, Health Canada acknowledges the value of RWD and RWE.

The agency is open to receiving submissions that rely on high-quality RWD and RWE in certain situations, such as:

  1. Expanding evidence-based indications for populations often excluded from clinical trials, including children, older adults, and expectant mothers
  2. Addressing diseases with limited treatment options or rare conditions
  3. Supporting post-market safety and effectiveness evaluations
  4. Informing the design of future clinical trials

The CADTH guidance provides a framework (and checklist) for reporting RWE studies, which can help researchers and healthcare professionals better understand the potential benefits and limitations of RWE in regulatory decision-making.

By promoting the use of high-quality RWD and RWE, the guidance aims to improve the overall quality of evidence available for drug development and regulatory decisions, ultimately benefiting patients and healthcare systems.

As a real-world evidence researcher or regulatory compliance specialist, you may find this guidance useful in your work, as it can help you provide actionable and engaging insights to researchers and healthcare professionals. By understanding and implementing the CADTH guidance, you can contribute to the development of more effective and efficient regulatory compliance solutions in the field of real-world evidence.

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Real World Evidence (RWE) 201 – Canada – Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making2023-09-03T16:42:17+00:00

Real World Evidence (RWE) 201 – Canada – Methods and Guidelines for Reporting Real World Evidence

RWE 201 – Canada – Methods and Guidelines for Reporting Real World Evidence


Guidance for Reporting Real-World Evidence (RWE) [published May 2023] is a comprehensive document developed by the Canadian Agency for Drugs and Technologies in Health (CADTH) and Health Canada to provide clear guidance on the conduct, reporting, and appraisal of RWE studies for regulatory approval and health technology assessment (HTA) in Canada.

Guidance Objectives:

  1. Ensure regulators and HTA agencies have ample information for evaluating a study’s appropriateness for decision-making.
  2. Establish core RWE study reporting standards that align globally.
  3. Prioritize transparent reporting while acknowledging RWD and RWE challenges.

Implementation: Given the diverse sources and uses of RWD, this guidance offers flexibility for various RWE applications. Some RWE studies might not need all components described here. The guidance anticipates updates as the RWE field evolves.

RWE Utility:

While randomized controlled trials (RCTs) are the gold standard for establishing the safety and efficacy of health technologies, they often lack wider applicability due to specific target populations. RWE, derived from RWD, has benefits like the inclusion of under-represented populations in trials, such as children, older adults, and diverse ethnic groups. Its expanded sample sizes and longer follow-ups offer a richer dataset than clinical trials, providing insights into healthcare provider and patient perspectives about accessibility and usability of health technologies. For instance, RWE is instrumental in pharmacovigilance and monitoring adverse events.

RWE Limitations: Concerns include biases, confounding factors, and the lack of rigorous outcome ascertainment as seen in clinical trials. Clear standards are essential for transparent reporting of RWE.

RWE Guidance Structure: Guidance is provided for the reporting of 12 study components as follows:

  1. Research Questions and Study Design
  2. Setting and Context
  3. Data Specifications, Access, Cleaning Methods, and Linkage
  4. Data Sources, Data Dictionary, and Variables
  5. Participants
  6. Exposure Definitions and Comparators
  7. Outcomes
  8. Bias, Confounding, and Effect Modifiers or Subgroup Effects
  9. Statistical Methods
  10. Study Findings
  11. Interpretation and Generalizability
  12. Limitations

In summary, this recent guidance aims to harmonize global and Canadian reporting standards for RWE through expert consensus. It includes a Recommendations Checklist to ensure compliance and is designed to be adaptable across different types of RWE studies, laying the groundwork for best practices and methodological rigor in using RWE for regulatory and HTA purposes.

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Real World Evidence (RWE) 201 – Canada – Methods and Guidelines for Reporting Real World Evidence2023-08-30T08:52:31+00:00

Real World Evidence (RWE) 201 – Health Canada’s 15 Key Elements for Protocol Development

RWE 201 – Health Canada’s 15 Key Elements for Protocol Development


Health Canada acknowledges that RWE can be particularly useful in areas where conducting controlled clinical trials is challenging or not feasible. By leveraging RWE, regulatory authorities can gain additional insights into drug safety and efficacy, ultimately improving access to safe and effective drugs for patients.

Protocol development is a critical step in ensuring the quality and validity of RWE studies. When designing a research protocol, several key elements should be considered:

[1] Research Question: Define the objectives, aims, and rationale, supplemented by a literature review.

[2] Milestones: Include timelines for data collection, progress reports, and study registration.

[3] Research Design: Clearly specify data type, measures of occurrence, and adverse events reporting.

[4] Study Populations: Define the study group and discuss its generalizability.

[5 & 6] Exposure & Outcome Measurement: Define, measure, and validate the exposure and outcomes pertinent to the study.

[7] Bias Mitigation: Identify potential biases and strategies to counter them.

[8] Effect Measure Modification: The protocol should address the collection of items that could modify the effect being studied and explain how they are included in the analysis.

[9] Data Sources: Describe sources and methods of data collection, including coding systems.

[10] Statistical Analysis: Detail statistical approaches, handling of missing data, and sensitivity analyses.

[11] Data Management: Outline storage, software, and quality control mechanisms.

[12] Feasibility & Limitations: Discuss the study’s viability and prospective mitigation strategies.

[13] Ethics & Data Protection: Emphasize participant protection, confidentiality, and ethical compliance.

[14] Amendments & Deviations: Document any changes to the original protocol.

[15] Communication Plan: Address how study results will be communicated and ensure transparency.

Data Quality in RWE:

[1] Prospective Data: Ensure transparency, defined procedures, and documentation for high-quality data.

[2] Retrospective Data: Despite its challenges, maintain high standards and traceability to the source.

In conclusion, these key elements of protocol development provide a framework for conducting high-quality RWE studies. Protocol development and data quality are crucial factors in ensuring the validity and reliability of RWE studies. By following good research practices and addressing elements such as research question, milestones, study design, data sources, statistical analysis, and data management, stakeholders can generate high-quality evidence to support regulatory submissions. Incorporating RWE into the drug product life cycle improves access to safe and efficacious drugs for patients, ultimately benefiting public health [1].



[1] Health Canada – Elements of Real World Data/Evidence Quality throughout the Prescription Drug Product Life Cycle (March 2019)


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Real World Evidence (RWE) 201 – Health Canada’s 15 Key Elements for Protocol Development2023-08-20T18:01:03+00:00
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