Journal: BMJ
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BMJ
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BMJ
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Publications 1 - 5 of 5
- Could artificial intelligence make doctors obsolete?Item type: Journal Article
BMJGoldhahn, Jörg; Rampton, Vanessa; Spinas, Giatgen A. (2018) - Robots, radiologists, and resultsItem type: Other Journal Item
BMJRampton, Vanessa; Ko, Athena (2022) - Rethinking research processes to strengthen co-production in low and middle income countriesItem type: Journal Article
BMJBeran, David; Pesantes, Maria Amalia; Berghusen, Maria Claudia; et al. (2021) - Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort studyItem type: Journal Article
BMJVokinger, Kerstin Noëlle; Glaus, Camille E.G.; Kesselheim, Aaron S.; et al. (2023)Objective: To analyze the therapeutic value of supplemental indications compared with first indications for drugs approved in the US and Europe. Design: Retrospective cohort study. Setting: New and supplemental indications approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) between 2011 and 2020. Main outcome measures: Proportion of first and supplemental indications rated as having high therapeutic value using ratings from the French and German national, independent health authorities. Results: The cohort study included 124 first and 335 supplemental indications approved by the FDA and 88 first and 215 supplemental indications approved by the EMA between 2011 and 2020; the largest subset was for cancer disorders. Therapeutic ratings were available for 107 (86%) first and 179 (53%) supplemental indications in the US and for 87 (99%) first and 184 (86%) supplemental indications in Europe. Among FDA approved indications with available ratings, 41% (44/107) had high therapeutic value ratings for first indications compared with 34% (61/179) for supplemental indications. In Europe, 47% (41/87) of first and 36% (67/184) of supplemental indications had high therapeutic value ratings. Among FDA approvals, when the sample was restricted to the first three approved indications, second indication approvals were 36% less likely to have a high value rating (relative ratio 0.64, 95% confidence interval 0.43 to 0.96) and third indication approvals were 45% less likely (0.55, 0.29 to 1.01) compared with the first indication approval. Similar findings were observed for Europe and when weighting by the inverse number of indications for each drug. Conclusions: The proportion of supplemental indications rated as having high therapeutic value was substantially lower than for first indications. When first or supplemental indications do not offer added therapeutic value over other available treatments, that information should be clearly communicated to patients and physicians and reflected in the price of the drugs. - Vaccine wastage as collateral damage in Ukrainian conflictItem type: Other Journal Item
BMJTsagkaris, Christos; Laubscher, Lily; Vladychuk, Valeriia (2022)
Publications 1 - 5 of 5