Textbook of clinical trials

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Ethical Issues Helsinki agreement Informed consent Investigational Review Board (IRB) HIPAA reidentification of patients and patient privacy

Regulatory issues and pathways in clinical trials The 1572 form and investigator responsibilities 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 Concomitant medications Clinical event committee or event adjudication committee Adverse events, serious adverse events and serious unexpected events Data safety monitoring board (DSMB) Study drug discontinuation, withdrawal of consent, incomplete follow up and lost to follow up 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 TIMI Risk Score Grace Risk Score