DOI: 10.1101/19003467Aug 1, 2019Paper

Patient Benefit and Risk in Anticancer Drug Development: A Systematic Review of the Ixabepilone Trial Portfolio

MedRxiv : the Preprint Server for Health Sciences
B. G. CarlisleJonathan Kimmelman


OBJECTIVE: To describe the patient burden and benefit, and the dynamics of trial success in the development of ixabepilone, a drug that was approved in the US but not in Europe. DATA SOURCES: Trials were captured by searching Embase and MEDLINE on July 27, 2015. STUDY SELECTION: Inclusion: 1) primary trial reports, 2) interventional trials, 3) human subjects, 4) phase 1 to phase 3, 5) trials of ixabepilone in monotherapy or combination therapy of 6) pre-licensure cancer indications. Exclusion: 1) secondary reports, 2) interim results, 3) meta-analyses, 4) retrospective/observational studies, 5) laboratory analyses (ex vivo tissues), 6) reviews, 7) letters, editorials, guidelines, interviews, abstract-only and poster presentations. DATA EXTRACTION AND SYNTHESIS: Data were independently double-extracted and differences between coders were reconciled by discussion. MAIN OUTCOMES AND MEASURES: We measured risk using the number of drug-related adverse events that were grade 3 or higher, benefit by objective response rate and trial outcomes by whether studies met their primary endpoint with acceptable safety. RESULTS: We identified 39 publications of ixabepilone monotherapy and 23 primary publications of combination therapy, represen...Continue Reading

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