Real World Evidence (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 – 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 [...]
Real World Evidence (RWE) 101 – Non-Interventional Studies vs Market Health Research
RWE 101 - Non-Interventional Studies vs Market Health Research Key differences between a non-interventional study (NIS) and market health research include:1. Research Objective: NIS are conducted to examine real-world [...]
Real World Evidence (RWE) 101 – Real World Evidence (RWE) 101 – Audits vs Inspections
RWE 101 - Real World Evidence (RWE) 101 - Audits vs Inspections In the context of regulatory compliance for Real-World Evidence (RWE), both audits and inspections play crucial roles, [...]
Real World Evidence (RWE) 101 – A Career of Many Pathways
RWE 101 - A Career of Many Pathways Real-world evidence (RWE) refers to the information on health care that is derived from analysis of real-world data (RWD). RWE [...]
Real World Evidence (RWE) 101 – Evolution of Regulatory Affairs
RWE 101 - Evolution of Regulatory Affairs Real-world evidence (RWE) and real-world data (RWD) are increasingly influencing regulatory affairs in the biopharmaceutical and healthcare industry. This change has been [...]
Real World Evidence (RWE) 101 – Project Managers
RWE 101 - Project Managers Real-World Evidence (RWE) observational studies and clinical trials are both key elements of medical research, but they involve very different methodologies, aims, and requirements. [...]