2021
DOI: 10.1002/cpt.2272
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Understanding Use of Real‐World Data and Real‐World Evidence to Support Regulatory Decisions on Medical Product Effectiveness

Abstract: RWE has potential to provide efficient and relevant information on the effectiveness of medical products, complementing the data generated in clinical trials; however, how RWE can support regulatory decision-making is unclear, potentially limiting its use. The objective of this study was to identify and characterize instances where RWE was included in the evidence package to support the effectiveness of a medical product regulated by U.S. Food and Drug Administration. A retrospective landscape analysis was con… Show more

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Cited by 46 publications
(40 citation statements)
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“…FDA has the longest historical record of accepting RWE into regulatory decision making, dating back to 1958 (37) and has the most sophisticated platform set up at multiple levels to generate and evaluate impact of RWE on product effectiveness and safety. However due to inconsistencies in review across different FDA divisions, recent reviews commented that trying to parse out whether RWE submitted was substantial, supportive, or other has not always been feasible (12,37). EMA on the other hand savoyed a more holistic approach working on multiple fronts in establishing the evidentiary value of RWE.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…FDA has the longest historical record of accepting RWE into regulatory decision making, dating back to 1958 (37) and has the most sophisticated platform set up at multiple levels to generate and evaluate impact of RWE on product effectiveness and safety. However due to inconsistencies in review across different FDA divisions, recent reviews commented that trying to parse out whether RWE submitted was substantial, supportive, or other has not always been feasible (12,37). EMA on the other hand savoyed a more holistic approach working on multiple fronts in establishing the evidentiary value of RWE.…”
Section: Discussionmentioning
confidence: 99%
“…(13) and more recently Mahendraratnam et. al (37) were the only recent publications on how RWE might have impacted regulatory decision made at a product level by FDA and EMA. The current publication is the first review article to provide insight into the use of RWE in the review of products approved by Health Canada in 2020 and 2021.…”
Section: Discussionmentioning
confidence: 99%
“…Norway and Sweden that required among others that medicines were 'medically justified' before marketing as early as 1928. 7,78,79 However, it would require another major safety crisis before the contours of current regulatory systems were established in other countries. In 1956, thalidomide was first marketed in Federal Republic of Germany and thereafter in many other countries over the world, 52,55 for a variety of indications and known under various brand names including Contergan, Softenon, Distaval, Talimol, and Kevadon.…”
Section: 2mentioning
confidence: 99%
“…Beoordeling van Verpakte Geneesmiddelen' -later renamed 'College ter Beoordeling van Geneesmiddelen' (Medicines Evaluation Board) -that already required preauthorisation evidence of quality, safety and efficacy. 78,83 However, the Act was only carried into effect in 1963 in response to the thalidomide crisis. 78,84 Notably, the Board was the only European regulatory agency with an executive committee whose opinion was binding.…”
Section: 2mentioning
confidence: 99%
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