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• W4255838115 abstract "We appreciate the responses to our Journal Club1Radecki R.P. Spiegel R.J. Adventures with andexanet alfa in efficacy, effectiveness, and one-armed studies: May 2019 Annals of Emergency Medicine Journal Club.Ann Emerg Med. 2019; 73: 545-547Abstract Full Text Full Text PDF Scopus (4) Google Scholar article by Drs. Milling and Connolly, and by Dr. Pallin. Publications in this section of Annals are intended to be succinct and broadly educational; it is not always possible to delve into the nuances and details of a topic. In response to Drs. Milling and Connolly's concerns, we regret any personal offense members of the study team may have felt by our mention of the ethical considerations of single-arm studies. Our point was that in this rapidly shifting field, equipoise should be assessed not only at trial inception but also continuously as new and alternative treatments emerge.2Freedman B. Equipoise and the ethics of clinical research.N Engl J Med. 1987; 317: 141-145Crossref PubMed Scopus (1693) Google Scholar Dr. Pallin's thoughtful comments highlight the challenges of drug development, Food and Drug Administration oversight, and the implications for the comparative clinical trial design. We, too, agree that postpublication peer review is necessary to help protect patients. Adventures With Andexanet Alfa in Efficacy, Effectiveness, and One-Armed Studies: May 2019 Annals of Emergency Medicine Journal ClubAnnals of Emergency MedicineVol. 73Issue 5PreviewConnolly SJ, Crowther M, Eikelboom JW, et al. Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. N Engl J Med. 2019; http://doi.org/10.1056/NEJMoa1814051 . Full-Text PDF Andexanet ResponseAnnals of Emergency MedicineVol. 74Issue 5PreviewWe read with interest the Annals Journal Club entry on andexanet alfa by Radecki and Spiegel.1 There are several issues with the discussion that we would like to address. First, the authors state that the preclinical work for idarucizumab was extensive enough arguably to make a placebo arm in the ReverseAD trial unethical. By implication, the authors contend andexanet had no such preclinical work and therefore the lack of a control arm in the ANNEXA-4 study was unethical. This is inaccurate. The development programs for both drugs had extensive preclinical programs in animals and cohorts of nonbleeding human beings. Full-Text PDF FDA Approval of Andexanet Alfa Based on a Single-Arm Trial: If There Is a Villain, Who Is It?Annals of Emergency MedicineVol. 74Issue 5PreviewA recent Annals Journal Club piece critiqued ANNEXA-4, sponsored by Portola Pharmaceuticals, the manufacturer of andexanet, arguing that it was unethical to conduct a single-arm trial, and that a placebo-controlled design should have been used.1,2 I was a coauthor on the critiqued article and chaired the sponsor’s Medical Advisory Panel that preceded Food and Drug Administration (FDA) approval and the drug’s launch, for pay. Full-Text PDF" @default.
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• W4255838115 doi "https://doi.org/10.1016/j.annemergmed.2019.05.035" @default.
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