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#1 Practical RWE – The Importance of Harmonised Definitions (RWR, RWD, RWE)

#1 Practical RWE – The Importance of Harmonised Definitions (RWR, RWD, RWE)

 

Definitions are crucial in the context of real-world research (RWR), real-world data (RWD), and real-world evidence (RWE) for several reasons:

  1. Clarity and Precision: In research, clear definitions ensure that everyone understands exactly what is being discussed. This is particularly important in RWD and RWE, where the data comes from a variety of sources and might be interpreted in different ways.
  2. Consistency: Definitions help maintain consistency across studies. In the realms of RWD and RWE, where studies often use data collected for other purposes, having standard definitions allows for more reliable comparisons and aggregations of data.
  3. Data Quality: Good definitions help ensure high-quality data. In real-world research, where data is not collected in controlled experimental settings (e.g., randomised controlled trials), clear definitions are essential for filtering and processing data effectively.
  4. Regulatory Compliance: In many fields, particularly in healthcare and pharmaceuticals, RWE is used to support regulatory decisions. Precise definitions are critical to meet the regulatory standards for evidence.
  5. Interdisciplinary Communication: RWD and RWE often involve collaboration across various disciplines. Clear definitions facilitate better communication and understanding among diverse groups of researchers, clinicians, policymakers, and other stakeholders.
  6. Replicability and Scalability: Well-defined concepts and methods enable other researchers to replicate studies or scale up research projects. This is vital for the advancement of science and policy-making.
  7. Data Integration: In real-world research, data often comes from multiple sources. Consistent definitions allow for more effective integration and analysis of this heterogeneous data.
  8. Targeted Interventions and Policies: In applied research, such as public health or market research, clear definitions help in designing more effective interventions and policies, as they allow for a precise understanding of the phenomena being addressed.

In essence, definitions lay the groundwork for accurate, consistent, and meaningful research, especially in areas where the data and its sources are as diverse and complex as in RWD and RWE.

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#1 Practical RWE – The Importance of Harmonised Definitions (RWR, RWD, RWE)2024-01-09T17:38:50+00:00

Real World Evidence (RWE) 101 – ICH GCP (R3) – Real World Evidence Context

RWE 101 – ICH GCP (R3) – Real World Evidence Context

Revision 2 of ICH GCP caused confusion to those of us who work with non-interventional studies. The glossary claimed that a ‘clinical trial’ was synonymous with a ‘clinical study’ (Section 1.12 of ICH GCP(R2)). This works if you conduct clinical trials (they are a type of clinical study), but not if you conduct non-interventional studies, which are a type of ‘clinical study other than a clinical trial’ (Article 2.2(4) of Regulation EU/536/2014).

The (draft) Revision 3 of ICH GCP, makes it clear “This guideline applies to interventional clinical trials of investigational products that are intended to be submitted to regulatory authorities. This guideline may also be applicable to other interventional clinical trials of investigational products that are not intended to support marketing authorisation applications in accordance with local requirements.”

Also, the new definition of ‘clinical trial’ provided in the Glossary, removes any confusion regarding clinical trial vs clinical study.

Clinical Trial = Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s); and/or to identify any adverse reactions to an investigational product(s); and/or to study absorption, distribution, metabolism and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.

The emphasis in ICH GCP(R3) is on ‘interventional’ investigations, although the term ‘intervention’ is missing from the Glossary…as well as most national clinical trial regulations. This may cause trialists some difficulties in the coming years when asked ‘what makes my non-interventional study…interventional?’

This revision to the clinical trial definition and explicit emphasis on ‘interventional clinical trials’ is a positive (constructive) move in the context of real world evidence as it removes the previously unnecessary confusion caused by revision 2 (i.e., clinical trial = clinical study).

The concept paper for Annex 2 was published on 28 April 2023, with the draft expected in 12 – 18 months. Annex 2 is of relevance to RWE because it will include additional considerations on how GCP principles may be applied across a variety of trial designs and data sources, where applicable. This will include:

1. Decentralised elements, where some or all trial-related activities occur at locations other than traditional clinical trial sites, and data collection may occur remotely.

2. Pragmatic elements, reflecting trials that closely resemble routine clinical practice.

3. Real-world data (RWD) sources [not including observational studies], for example, the use of registries, electronic health records (EHR), hospital data, pharmacy and medical claims data or wearables

Next? Is it time for similar harmonised guidelines for ‘non-interventional studies’?

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Real World Evidence (RWE) 101 – ICH GCP (R3) – Real World Evidence Context2023-08-09T15:27:28+00:00

Real World Evidence (RWE) 101 – The Importance of Regulatory Definitions

RWE 101 – The Importance of Regulatory Definitions

“Words are powerful”

Regulatory definitions are important in the context of real-world evidence (RWE) studies and real-world research for several reasons:

[1] Consistency: Regulatory definitions provide a consistent framework for generating and evaluating RWE across different stakeholders, including regulatory agencies, industry, and academia. By providing a clear and consistent definition of RWE, stakeholders can ensure that they are using the same language and criteria for evaluating the quality and relevance of RWE.

[2] Standards: Regulatory definitions help establish standards for the use of RWE in regulatory decision-making. For example, regulatory definitions may specify the types of RWE that are acceptable for use in regulatory submissions, the study designs that are appropriate for generating RWE, and the quality standards that must be met to ensure the reliability and validity of RWE.

[3] Decision-making: Regulatory definitions facilitate regulatory decision-making by providing a clear framework for evaluating the quality and relevance of RWE. By establishing clear criteria for evaluating RWE, regulatory agencies can make more informed decisions about the safety, efficacy, and quality of healthcare products.

[4] Transparency: Regulatory definitions promote transparency by providing a clear and consistent framework for generating and evaluating RWE. This can help ensure that stakeholders are aware of the criteria used to evaluate RWE and can provide input into the development of regulatory definitions.

[5] Compliance: Regulatory definitions help ensure compliance with regulatory requirements. By providing a clear definition of RWE and the standards for generating and evaluating it, stakeholders can ensure that their studies and research meet regulatory requirements.

In summary, regulatory definitions are important in the context of RWE studies and real-world research because they provide consistency, establish standards, facilitate decision-making, promote transparency, and ensure compliance with regulatory requirements. By providing a clear and consistent framework for generating and evaluating RWE, regulatory definitions can help stakeholders make more informed decisions about the safety, efficacy, and quality of healthcare products.

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Real World Evidence (RWE) 101 – The Importance of Regulatory Definitions2023-08-07T12:42:16+00:00
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