Design and analysis of clinical trials with time-to-event endpoints

  • 2.
    1. What is the question? The design of every clinical trial starts with a primary clinical research question
      2. . 2.
    2. Minimizing variation
      3. . 2.
    3. Randomization and stratification
      4. . 2.
    4. Blinding
      5. . 2.
    5. Placebos/Shams
      6. . 2.
    6. Selection of a control group
      7. . 2.
    7. Selection of a population and entry criteria
      8. . 2.
    8. Selection of endpoints

  • How do you Analyse a clinical trial?

    Box: Key questions to ask when assessing clinical data

    1. What are the study's limitations?
    2. Does this apply to my patient?
    3. Is my patient sufficiently similar to the patients in the studies examined?
    4. Does the treatment have a clinically relevant benefit that outweighs the harms?
    5. Is another treatment better?

  • How do you select clinical trial endpoints?

    The selection of the primary endpoint is made to address the primary objective of the trial.
    The primary end-point should be clinically relevant, interpretable, sensitive to the effects of intervention, practical and affordable to measure, and ideally can be measured in an unbiased manner..

  • What are the different types of study designs in clinical trials?

    Clinical trials are further divided into randomized clinical trial, non‐randomized clinical trial, cross‐over clinical trial and factorial clinical trial..

  • What are the endpoints of a clinical trial design?

    An endpoint is a targeted outcome of a clinical trial that is statistically analyzed to help determine the efficacy and safety of the therapy being studied.
    Endpoints for a clincial trial may include one or more clinical outcome assessment and/or surrogate endpoint..

  • What are time to event endpoints in clinical trials?

    For time-to-event endpoints power is driven by the number of “events” (e.g., for survival, the event is death; for time-to-relapse the event is relapse).
    Numbers of events are driven by the rate at which they occur, the interval subjects were accrued and how long each subject was observed since study-entry..

  • The design of a clinical trial describes a sequence and structure of activities aiming to reveal a cause and effect relationship – defined in the research question.
    All trials begin with a single group of participants (the COHORT) who are selected to represent a defined disease population.
  • The selection of the primary endpoint is made to address the primary objective of the trial.
    The primary end-point should be clinically relevant, interpretable, sensitive to the effects of intervention, practical and affordable to measure, and ideally can be measured in an unbiased manner.
Design and Analysis of Clinical Trials with Time-to-Event Endpoints provides a thorough presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest.

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