Textbook of clinical trials
Ethical Issues
Helsinki agreement
Informed consent
Investigational Review Board (IRB)
HIPAA and patient privacy
Regulatory issues and pathways in clinical trials
1572
Investigational new drug (IND) application
Investigational new drug or device exemption
510K pathway
Designing Clinical Trials
Randomized controlled trials versus observational studies
Phase 1 trials
Pharmacokinetic (PK) and pharmcodynamic (PD) assessment
Phase 2 trials
Advancing from phase 2 to a phase 3 trial
Phase 3 trials
Parallel versus dose escalation studies
Hypothesis Generation
Inclusion and exclusion criteria
Stratification
Primary endpoint
Secondary endpoints and exploratory endpoints
Surrogate endpoints
Sample size and power calculations
Protocol creation
Abbreviations used in clinical trials
Operationalizing Clinical Trials
Principal investigator role
Executive committee role
Steering committee role
Nurse coordinator clinical research associate role
Monitor role
Sponsor role
Randomization service
Central laboratory facility
EKG core laboratory
Angiographic core laboratory
MRI core laboratory
Genetics core laboratory
Biomarker core laboratory
Identification of sites
Randomization
Blinding
Recruitment of study participants
Electronic data collection
Schedule of events
Concommittant medications
Clinical events committee
Adverse event, serious adverse event and serious unexpected events
Data safety monitoring board (DSMB)
Minimizing incomplete follow up of patients
Protocol adherence
Storage and handling of investigational product
Data management and designing an electronic data capture form
Source documents
Study completion and close out
Protocol amendments
Publication committee
Statistical Analysis of Clinical Trials
Cleaning a dataset
Summary statistics
Intent to treat versus modified intent to treat versus as treated
Student's t tests and analysis of variance
Chi square analysis and Fisher's exact test
Logistic regression
Multivariate modeling
Survival analysis
Handling missing data
Subgroup and interaction analyses
Net clinical benefit analyses
Cost effectiveness analyses
Quality adjusted life year analyses
Interim analyses and futility analyses
Reporting results and how to write a manuscript
Meta-analysis
Positive publication bias
"Study Tools"
GFR calculation