| dc.description.abstract | The present scoping review aimed to study how uncertainty is defined in the drug regulatory field. Articles in which uncertainties were described from a regulatory perspective were analysed. Further, only records written in English available through the Utrecht University Library were included. Pubmed and Embase were searched until 16th January of 2023. Systematic literature reviewer programs Rayyan and AsReview were used to eliminate duplicates and screen articles based on title and abstract. To reduce bias, articles for which relevancy was questioned were peer reviewed. A flowchart summarizing the decision making as well as four tables summarizing the findings were included. In total, 103 articles discussing and/or defining uncertainty in regulatory sciences were identified. From the articles the following different main classifications of uncertainty were observed: clinical, regulatory, benefit-risk, economic, quality uncertainty, and market uncertainty, which also contained subclassifications. The present scoping review presented the lack of consistency across articles, the grey areas between the different classifications, and the intrinsic subjectivity of the topic. In conclusion, there was no clear definition of uncertainty in drug regulatory sciences. Drug regulators should provide a clear definition of uncertainties and clarify the context in which they arise. | |
