The International Society of Pharmacoepidemiology (ISPE) Good Pharmacoepidemiology Practices (GPP) provides guidance for the conduct and reporting of pharmacoepidemiologic studies. The key points of ISPE GPP include:
Study Design and Conduct: ISPE GPP emphasizes the importance of study design and conduct to ensure the validity and reliability of study results. The guide provides guidance on study design, sample selection, data collection, and analysis.
Data Sources and Quality: ISPE GPP provides guidance on the selection and use of data sources, such as administrative databases, electronic health records, and patient registries. The guide emphasizes the importance of data quality and the need to validate data sources and ensure data completeness.
Ethical Considerations: ISPE GPP emphasizes the importance of ethical considerations in pharmacoepidemiologic studies, including informed consent, confidentiality, and protection of human subjects.
Reporting and Dissemination of Results: ISPE GPP provides guidance on the reporting and dissemination of study results, including the need to provide clear and transparent reporting of study methods, results, and limitations.
Collaboration and Communication: ISPE GPP emphasizes the importance of collaboration and communication among researchers, stakeholders, and the public to ensure the appropriate use and interpretation of study results.
Share this story...
Real World Evidence (RWE) 101 – NICE Real World Evidence Framework
RWE 101 - NICE Real World Evidence Framework The UK's National Institute for Health and Care Excellence (NICE) has developed a Real World Evidence (RWE) Framework to help evaluate [...]
Real World Evidence (RWE) 101 – The Role of RWE in Health Technology Assessments (HTAs)
RWE 101 - The Role of RWE in Health Technology Assessments (HTAs) Real-world evidence (RWE) is becoming increasingly important in the context of health technology assessment (HTA), which is [...]
Real World Evidence (RWE) 101 – Verifying the Source of Data (Not to be Confused with Source Data Verification…Yup! Confusing!)
RWE 101 - Verifying the Source of Data (Not to be Confused with Source Data Verification...Yup! Confusing!) Verifying the source of data is critical in the context of real [...]
Real World Evidence (RWE) 101 – Challenges in RWE Generation (Regulatory Grade RWE?)
RWE 101 - Challenges in RWE Generation (Regulatory Grade RWE?) Real-world evidence (RWE) refers to data derived from real-world sources such as electronic health records, claims data, and patient-generated [...]
Real World Evidence (RWE) 101 – Challenges Pharma Companies Face when Using RWE to Support Marketing Authorisations
RWE 101 - Challenges Pharma Companies Face when Using RWE to Support Marketing Authorisations Real-world evidence (RWE) studies include observational studies that uses data collected in real-world settings to [...]
Real World Evidence (RWE) 101 – Acknowledgement of the Limitations of Clinical Trials and RWE Studies
RWE 101 - Acknowledgement of the Limitations of Clinical Trials and RWE Studies Clinical trials are experiments designed to test the safety and efficacy of new treatments or [...]







