RWE 101 – ISPE GPP
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 – Registry vs Registry-Based Study
RWE 101 - Registry vs Registry-Based Study In the context of real-world evidence, a registry is a collection of data on a particular disease, medical condition, or [...]
Real World Evidence (RWE) 101 – Pregnancy Registries
RWE 101 - Pregnancy Registries A pregnancy registry is a type of real-world evidence collection system that collects data from pregnant women who have been exposed to [...]
Real World Evidence (RWE) 101 – Diversity
RWE 101 - Diversity Diversity in the context of real-world research refers to the inclusion of individuals from different backgrounds, including but not limited to race, ethnicity, gender, [...]
Real World Evidence (RWE) 101 – The Patient Voice
RWE 101 - The Patient Voice The patient voice refers to the perspectives, opinions, and experiences of patients and their families or caregivers in the context of [...]
Real World Evidence (RWE) 101 – ISPE GPP
RWE 101 - ISPE GPP The International Society of Pharmacoepidemiology (ISPE) Good Pharmacoepidemiology Practices (GPP) provides guidance for the conduct and reporting of pharmacoepidemiologic studies. The key [...]
Real World Evidence (RWE) 101 – EMA Good Pharmacovigilance Practices (GVPs)
RWE 101 - EMA Good Pharmacovigilance Practices (GVPs) The European Medicines Agency's (EMA) Good Pharmacovigilance Practices (GVPs) provide a framework for the monitoring and reporting of adverse drug [...]
