Dose-level toxicity and efficacy outcomes from dose-finding clinical trials in oncology

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data http://eprints.org/relation/isVersionOf http://edata.bham.ac.uk/id/document/1917 http://eprints.org/relation/isVolatileVersionOf http://edata.bham.ac.uk/id/document/1917 http://eprints.org/relation/isIndexCodesVersionOf http://edata.bham.ac.uk/id/document/1917 archive 117 disk0/00/00/03/37 2019-05-07 11:18:43 2020-12-15 15:22:03 2019-05-07 11:18:43 data_collection show Brock Kristian K.Brock@bham.ac.uk 0000-0002-3921-0166 Homer Victoria Soul Gurjinder Potter Claire Chiuzan Cody Lee Shing Dose-level toxicity and efficacy outcomes from dose-finding clinical trials in oncology 10col_mede Clinical trial, Phase I, Phase 1, Dose-finding, dose finding, toxicity, DLT, dose limiting toxicity, MTD, maximum tolerable dose, RP2D, recommended phase 2 dose, AE, adverse event, efficacy, response, RECIST, 3+3, CRM, EWOC https://github.com/brockk/dosefindingdata This dataset contains information on the outcomes observed at each dose-level in a large number of dose-finding clinical trials in oncology. These trials typically seek to identify a maximum tolerable dose or a recommended phase 2 dose. A common rule-based method for conducting such trials is the 3+3 algorithm. A common model-based alternative is the continual reassessment method (CRM). Each of these methods assumes that as dose is increased, the probabilities of toxicity and efficacy will each increase monotonically. If this assumption is violated, both methods may recommend inappropriate doses. For instance, if the probability of efficacy does not increase in dose but the probability of toxicity does, the 3+3 and CRM designs may recommend a dose that is unjustifiably high. The same is true of any design that assumes that "more is better". We collated this dataset to investigate the appropriateness of the monotonicity assumptions in dose-finding clinical trials. See README or https://github.com/brockk/dosefindingdata for more information. v1.1 is a minor update correcting typos. 2019-05-05 published University of Birmingham 10.25500/edata.bham.00000337 Dataset research-data@contacts.bham.ac.uk Cancer Research UK Clinical Trials Unit Institute of Cancer and Genomic Sciences other yes yes yes TRUE Principal Statisticican Brock Kristian K.Brock@bham.ac.uk https://github.com/brockk/dosefindingdata web https://github.com/brockk/dosefindingdata IsDocumentedBy en