Real-World Data and Real-World Evidence (RWD/RWE) have been utilized not only for drug safety assessment but also for efficacy evaluation for drug approval at global basis. Over the years, many real examples of RWD/RWE utilization for regulatory purposes such as new drug approvals or safety measures have been accumulated with more diversifications in terms of data source, methodology, and study region. Scientific discussions toward international harmonization have been more active in related academic conferences and scientific journals. This research topic is proposed as a platform for sharing experiences and knowledge on RWD/RWE utilization for efficient development and better benefit/risk assessment of a drug, aiming to promote common understanding about recent advancement of RWD/RWE utilization in drug development and evaluation including advantage, limitation, and challenge. Global sharing of experiences and perspectives on the RWD/RWE utilization facilitates scientific discussions and contributes to promoting international harmonization in this area. We welcome all types of articles including original research, review, and general commentary. The expected articles in this research topic include the following but are not limited to: • Pharmacoepidemiological study to examine the efficacy and/or safety of a drug in the pre- or post- marketing stage• Methods for better analysis and interpretation of drug efficacy and/or safety based on RWD/RWE• Outcome validation study for examining the efficacy and/or safety of a drug • Remained challenges for promoting RWD/RWE utilization in drug development and/or drug evaluation• Impacts of RWE for regulatory decision-making such as drug approval and safety measure• Advancement of drug evaluation process or framework with the use of RWD/RWE for better decision-makingK. Arnold Chan is employed by TriNetX. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
Real-World Data and Real-World Evidence (RWD/RWE) have been utilized not only for drug safety assessment but also for efficacy evaluation for drug approval at global basis. Over the years, many real examples of RWD/RWE utilization for regulatory purposes such as new drug approvals or safety measures have been accumulated with more diversifications in terms of data source, methodology, and study region. Scientific discussions toward international harmonization have been more active in related academic conferences and scientific journals. This research topic is proposed as a platform for sharing experiences and knowledge on RWD/RWE utilization for efficient development and better benefit/risk assessment of a drug, aiming to promote common understanding about recent advancement of RWD/RWE utilization in drug development and evaluation including advantage, limitation, and challenge. Global sharing of experiences and perspectives on the RWD/RWE utilization facilitates scientific discussions and contributes to promoting international harmonization in this area. We welcome all types of articles including original research, review, and general commentary. The expected articles in this research topic include the following but are not limited to: • Pharmacoepidemiological study to examine the efficacy and/or safety of a drug in the pre- or post- marketing stage• Methods for better analysis and interpretation of drug efficacy and/or safety based on RWD/RWE• Outcome validation study for examining the efficacy and/or safety of a drug • Remained challenges for promoting RWD/RWE utilization in drug development and/or drug evaluation• Impacts of RWE for regulatory decision-making such as drug approval and safety measure• Advancement of drug evaluation process or framework with the use of RWD/RWE for better decision-makingK. Arnold Chan is employed by TriNetX. All other Topic Editors declare no competing interests with regards to the Research Topic subject.