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Fast Facts: Clinical Trials in Oncology

出版社
出版日期
2020/12/18
閱讀格式
EPUB
書籍分類
學科分類
ISBN
9781912776740

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Written by leading experts, 'Fast Facts: Clinical Trials in Oncology' will enhance the reader’s ability to critically evaluate published evidence. Assuming little or no prior knowledge, the book sets out clearly the fundamental features of clinical trials. The key attributes of Phase I–III trials of pharmaceutical products are described, as are trials of surgical procedures, radiation therapy and advanced therapies. The processes and documentation required to set up and conduct a trial are outlined, and the authors describe how trial data and real-world evidence are used to improve care. Although this concise colorful book focuses on oncology, the principles apply equally to interventions in other areas of practice. It will prove invaluable to medical, pharmaceutical and allied health professionals who want, or need, an overview of how contemporary clinical trials are designed and conducted.
  • Cover
  • Title Page
  • Copyright
  • Contents
  • List of abbreviations
  • Introduction
  • 1. Fundamental features of clinical trials
    • What is a clinical trial?
    • Objectives
    • Patients
    • Interventions
    • Comparator (control)
    • Randomization
    • Outcome measures (also called endpoints)
    • Follow-up
    • Sample size
    • Translational research
    • Statistical analyses
  • 2. Phase I trials
    • Purpose
    • Participants
    • Trial designs
    • Outcome measures
    • Sample size
    • Conduct
    • Interpreting and reporting results
  • 3. Phase II trials
    • Participants
    • Common designs
    • Outcome measures
    • Sample size
    • Trials using biomarkers
    • Trial analyses and interpretation
    • Conduct
  • 4. Phase III trials
    • Participants
    • Setting
    • Interventions
    • Blinding
    • Trial design
    • Trial outcome measures
    • Study size
    • Analysis and interpretation of results
    • Subgroup analyses
    • Trials using biomarkers
    • Overall interpretation of benefit
  • 5. Trials of non-drug interventions
    • Surgery
    • Radiation therapy
    • Cell and gene therapy
  • 6. Setting up and conducting trials
    • Critical roles
    • Regulations and guidelines
    • Documentation
    • Ethics approval
    • Regulatory approval
    • Manufacturing and distribution of trial drugs
    • Registering the trial
    • Conducting the trial
    • Monitoring study sites
    • Audit and inspection
    • Ongoing independent review and monitoring
    • Statistical analysis plan
    • Closing the trial
    • Why trials ‘fail’
  • 7. Publishing trial results, changing clinical practice, and supporting evidence
    • Reporting and publishing trial results
    • Marketing authorization
    • Market access (reimbursement)
    • Health economic evaluation
    • Systematic reviews and meta-analyses
    • Real-world evidence/data
  • Index
  • 出版地 德國
  • 語言 德文

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