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Open clinical trial data for all? A view from regulators.
Eichler HG, Abadie E, Breckenridge A, Leufkens H, Rasi G. Eichler HG, et al. Among authors: rasi g. PLoS Med. 2012;9(4):e1001202. doi: 10.1371/journal.pmed.1001202. Epub 2012 Apr 10. PLoS Med. 2012. PMID: 22505851 Free PMC article.
Access to patient-level trial data--a boon to drug developers.
Eichler HG, Pétavy F, Pignatti F, Rasi G. Eichler HG, et al. Among authors: rasi g. N Engl J Med. 2013 Oct 24;369(17):1577-9. doi: 10.1056/NEJMp1310771. Epub 2013 Oct 21. N Engl J Med. 2013. PMID: 24144395 Free article. No abstract available.
Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?
Eichler HG, Bloechl-Daum B, Broich K, Kyrle PA, Oderkirk J, Rasi G, Santos Ivo R, Schuurman A, Senderovitz T, Slawomirski L, Wenzl M, Paris V. Eichler HG, et al. Among authors: rasi g. Clin Pharmacol Ther. 2019 Apr;105(4):912-922. doi: 10.1002/cpt.1226. Epub 2018 Oct 14. Clin Pharmacol Ther. 2019. PMID: 30178490 Free PMC article.
Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth.
Eichler HG, Pignatti F, Schwarzer-Daum B, Hidalgo-Simon A, Eichler I, Arlett P, Humphreys A, Vamvakas S, Brun N, Rasi G. Eichler HG, et al. Among authors: rasi g. Clin Pharmacol Ther. 2021 May;109(5):1212-1218. doi: 10.1002/cpt.2083. Epub 2020 Nov 12. Clin Pharmacol Ther. 2021. PMID: 33063841 Free PMC article. Review.
The risks of risk aversion in drug regulation.
Eichler HG, Bloechl-Daum B, Brasseur D, Breckenridge A, Leufkens H, Raine J, Salmonson T, Schneider CK, Rasi G. Eichler HG, et al. Among authors: rasi g. Nat Rev Drug Discov. 2013 Dec;12(12):907-16. doi: 10.1038/nrd4129. Epub 2013 Nov 15. Nat Rev Drug Discov. 2013. PMID: 24232377 Review.
107 results