Real World Evidence (RWE) 101 – Protocol Design and ISPE GPP

RWE 101 – Protocol Design and ISPE GPP

The International Society for Pharmacoepidemiology (ISPE) Guidelines for Good Pharmacoepidemiology Practices (GPP) are a set of best practices for the conduct of pharmacoepidemiologic research, which includes the creation and analysis of real-world evidence (RWE).
ISPE GPP provides a benchmark for quality in pharmacoepidemiology studies, covering all aspects of the research process from study design and conduct to communication of study results. They provide guidance on maintaining ethical standards, ensuring data quality and integrity, managing study data and documents, managing and reporting adverse events, and many other facets of study conduct. Regulatory bodies in the USA, Canada, EU and Germany recommend that ISPE should be considered by marketing authorisation holders and investigators for the development of study protocols, the conduct of studies and the writing of study reports.
In the context of RWE and RWE study protocols, ISPE GPP is particularly important for the following reasons:
1. Enhanced Credibility and Quality of Studies: Adhering to ISPE GPP can help to ensure that RWE studies are designed and conducted to a high standard, which enhances their credibility and the reliability of their results.
2. Consistency and Comparability: ISPE GPP provide a consistent framework for RWE studies, which can facilitate comparison between studies and encourage uniformity in research practices. For example:
– Section II of ISPE GPP provides detailed guidance on protocol design and context
– Section IV covers study conduct and study reporting
3. Ethical Conduct: The guidelines provide recommendations for maintaining ethical standards throughout the research process, including the protection of study participants and the use of their data.
4. Regulatory Compliance: RWE is being increasingly used by regulatory agencies to inform decisions about the safety and effectiveness of treatments. Adhering to ISPE GPP can help to ensure that studies meet the standards expected by these agencies.
5. Transparency: The guidelines promote transparency in the reporting of study methods and results, which is crucial for the interpretation and validation of RWE.
6. Archiving: In the absence of national requirements or guidance, ISPE GPP recommends that study-related materials be maintained for at least five years after final report or first publication of study results.
In essence, following ISPE GPP can ensure that RWE studies are conducted to a high scientific and ethical standard, increasing their value to healthcare providers, regulators, and patients.

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