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KMID : 0370220220660020066
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Yakhak Hoeji
2022 Volume.66 No. 2 p.66 ~ p.75
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Focus Group Interview of Stakeholders to Derive Checklists for Future Real-world Data and Real-world Evidence Use in Regulatory Decision Making for Drugs
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Ahn Hyeong-Soo
Kwon Sol
Lee Han-Kil
Kang Hye-Young
Han Eun-A
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Abstract
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The limitations of randomized clinical trials (RCTs) have been highlighted in regulatory decision-making. Thus,the requirement for real-world data (RWD) and real-world evidence (RWE) is growing. However, the definition of RWDis ambiguous in domestic laws and regulations, and drug safety management systems that use RWD are insufficient. Weconducted focus group interviews (FGIs) regarding the definition of RWD and the approaches national institutions orindustries must adopt to introduce RWD/RWE in regulatory decisions for the entire drug life cycle. Experts from academia,industry, government, and medical fields who have experience with RWD/RWE research were requested to participate inFGIs by email. The participants were classified into three groups (academia, industry, and government and medicalprofessionals). Online discussions were conducted for each group. A total of 16 stakeholders were recruited for the FGIs:five from academia, seven from industry, three from government agencies, and one from the medical field. Mostparticipants agreed with the opinion that RWD has not been collected through traditional clinical trials and should bedefined comprehensively. The experts also suggested that national institutions and industries should prepare guidelines andinfrastructure regarding RWD collection, RWE generation, and RWD/RWE management. In conclusion, national institutionsand industries should set short- and long-term goals to introduce RWD/RWE in regulatory decision-making.
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KEYWORD
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Focus group interview, Real-world data, Real-world evidence, Regulatory decision making
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