Clinical trials
Pawlik, Timothy M.

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  • Clinical trials
  • 紀錄類型: 書目-電子資源 : Monograph/item
    正題名/作者: Clinical trials/ edited by Timothy M. Pawlik, Julie A. Sosa.
    其他作者: Pawlik, Timothy M.
    出版者: Cham :Springer International Publishing : : 2020.,
    面頁冊數: vi, 258 p. :ill., digital ;24 cm.
    內容註: History of Clinical Trials -- Ethics (COI, informed consent) -- Generating a Testable Hypothesis and Underlying Principles of Clinical Trials -- Trial Design: Overview of Study Designs (phase I, II, III, IV, factorial design) -- Defining the Study Cohort: Inclusion and Exclusion criteria (establishing eligibility and exclusion criteria, how should one define a cohort, balance between being inclusive versus selective / efficacy versus effectiveness trials) -- Building your Clinical Trial Research Team (how to assemble the team: database manager, research nurse) -- Clinical Trials: Ensuring Quality and Standardization (GCP, reporting of AE's, establishing SOPs, CRF's) -- Device versus Drug Clinical Trials: Similarities and Important Differences -- Statistics - Setting the Stage (Sample Size, Power, Randomization, Type II error, Treatment allocation/stratification) -- Statistics - Handling the Data (Intention to Treat analyses, Subgroups analyses, expressing the data (relative risk), handling missing data) -- Data Safety Monitoring Board: Interim Analyses, Stopping Rules -- Planning for Data Monitoring and Audit -- Clinical Trials: The Budget -- Regulatory Issues (compliance issues, IRB, FDA) -- Publishing your Clinical Trial (authorship, manuscript preparation, journal selection) -- Pragmatic clinical trials -- Cooperative trials -- International trials -- Inclusion of Patient Reported Outcomes -- Participation in clinical trials/as a clinical trialist for the community surgeon.
    Contained By: Springer eBooks
    標題: Surgery - Research -
    電子資源: https://doi.org/10.1007/978-3-030-35488-6
    ISBN: 9783030354886
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