#11 Practical RWE – Documentation: Non-Interventional Study Protocols


Having dedicated protocol templates for non-interventional studies (RWE studies) and clinical trials is a must rather than a ‘nice to have’ for several reasons:

  1. Different Objectives and Designs: Clinical trials and non-interventional studies have distinct objectives and designs. Clinical trials are designed to test the efficacy and safety of a new treatment under controlled conditions. In contrast, non-interventional RWE studies observe and analyse the outcomes of treatments in real-world settings without the researcher influencing or altering standard care practices.
  2. Regulatory Compliance: Clinical trials are subject to stringent regulatory requirements, including those set by the FDA, EMA, and other health authorities. These regulations ensure patient safety and data integrity and require specific protocol elements, such as detailed inclusion and exclusion criteria, randomization procedures, and stringent data collection methods. RWE studies, while also regulated, have different compliance requirements.
  3. Data Collection and Analysis: Clinical trials often involve rigorous data collection and analysis methods, including controlled environments, placebo controls, and double-blinding. RWE studies, on the other hand, typically rely on data from healthcare databases, patient registries, or routine clinical practice. Dedicated templates ensure that the protocols for each study type include appropriate guidelines for data collection, handling, and analysis.
  4. Risk Management: Different study types have different risk profiles. Clinical trials often involve unapproved treatments, requiring detailed risk management plans. RWE studies might involve fewer direct risks to participants but require careful consideration of data privacy and ethical concerns in observational settings. Separate templates can ensure that risk management is appropriately addressed in each type of study.
  5. Stakeholder Expectations: Clinical trials are often viewed as the gold standard for evidence generation, whereas RWE studies provide complementary insights into how treatments work in everyday clinical practice. Having distinct templates helps in clearly communicating the purpose, scope, and limitations of each study type to stakeholders.
  6. Efficiency and Clarity: Dedicated templates streamline the protocol development process for each study type. They ensure that researchers consider all relevant aspects and adhere to best practices specific to the study design. This clarity and efficiency can expedite the study approval process, reduce administrative burdens, and enhance the quality of the research.

In summary, having separate protocol templates for non-interventional studies and clinical trials is essential for aligning with specific study objectives, meeting regulatory requirements, ensuring appropriate data collection and analysis methods, managing risks effectively, meeting stakeholder expectations, and enhancing overall research efficiency and clarity.

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