Clinical Trials Homework Help

Clinical Trials Homework Help

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The Domain

  • Historical remarks, some diseases and discoveries
  • Steps(phases)in drug development
  • Scope of clinical trials: new drugs, generics, devices, psychiatric therapy, alternative medicine.
  • Role of statistics

Planning a Clinical Trial – Statistican’s Inputs

  • Principles of design of experiments (replication, local control, randomization)
  • Power and sample size
  • Bias reduction (blinding)
  • Commonly used designs

Statistical Analysis Plan (SAP) of Clinical Trial

  • Trial objectives, hypotheses, choice of techniques, nature of endpoints
  • End point Binary: A Randomizated Evaluation of First-Dollar Coverage for Post-MI Secondary Preventive Therapies (Post-MI FREEE)
  • End point – Normal: accuracy study of SoftTouch (a non-invasive device for measurement of peripheral blood biomarkers)
  • End point – count data: Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)
  • End point – non-Normal: TBTC Study 27/28 PK: Moxifloxacin Pharmacokinetics During TB Treatment

Illustrative Statistical Analysis of Clinical Trial Data

  • One sample problem – reduction in blood pressure
  • Two sample problem – anorexia
  • K-sample problem – drowsiness due to antihistamines
  • Cochrane’s Q test – allergic response
  • Analysis of Time-concentration data in pharmacokinetic study

Pharmacokinetics (PK) and Bioavailability

  • Basic concepts of PK
  • PK analysis of time-concentration data (bioavailability assessment)
    • Oral administration
    • Estimation of Cmax, Tmax, AUC, Ke, Ka
    • Intravenous administration
  • Dose-response modeling
    • Types of dose-response relationships
      • Michaelis-Menton model for saturating relationship
      • Power model: A model that includes three shapes

Inference for Pharmocokinetic (PK) data

  • Normality testing of PK parameters (AUC, Cmax)
  • Transformations for achieving normality (AUC, Cmax)
  • Parametric (AUC, Cmax) and Non-parametric tests (Tmax)
  • Bootstrap confidence interval for t1/2

Analysis of Dose-Response Data

  • Estimation of median effective dose
  • Testing of dose proportionality in power model

Bioequivalence Studies-Parallel Design

  • Statistical equality vs. clinical equivalence
  • Testing bioequivalence (AUC)
  • CI approach (AUC)
  • Testing bioequivalence (Cmax)
  • CI approach (Cmax)

Bioequivalence Studies 2 x 2 (Crossover Design)

  • What is crossover design?
  • Analysis of illustrative data using two sample tests
    • Test for carry over effect
    • Test for period effect
    • Test for treatment difference
  • Testing equivalence using CI
    • Parallel vs. crossover design

Treatment Comparisons

  • R fundamentals associated with clinical trials
  • A simple simulated clinical trial
  • Statistical models for treatment comparisons
  • Incorporating covariates

Survival Analysis

  • Time-to-event data structure
  • Statistical models for survival data
  • Right-censored data analysis
  • Interval-censored data analysis

Analysis of Data from Longitudinal Clinical Trials

  • Trial designs and data structure
  • Statistical models and analysis

Analysis of Bioequivalence Clinical Trials

  • Data from bioequivalence clinical trials
  • Bioequivalence clinical trial endpoints
  • Statistical methods to analyze bioequivalence

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