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- W4313645223 abstract "For the overall ordered programme of clinical trials to be scientifically sound, there needs to be a substantial amount of commonality across the trials in terms of endpoints, estimands, definitions of analysis sets, recording of covariates and so on. Statistical thinking and practice in the pharmaceutical industry is very much determined by the regulatory guidelines that are in place. This chapter looks at the results of that planning in terms of the statistical methods section of the protocol and, following on from that, what happens from a statistical standpoint once the trial is ongoing through to the final reporting of that trial and construction of the regulatory package. The statistics groups involved in analysing and reporting each trial have a role in compiling the regulatory submission. Outside of the clinical report and regulatory submission, the results of trials need to be published in the medical literature and presented at conferences and meetings." @default.
- W4313645223 created "2023-01-07" @default.
- W4313645223 date "2023-01-03" @default.
- W4313645223 modified "2023-09-26" @default.
- W4313645223 title "The role of statistics and statisticians" @default.
- W4313645223 doi "https://doi.org/10.1002/9781119867418.ch21" @default.
- W4313645223 hasPublicationYear "2023" @default.
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