Textbook of clinical trials

Ethical Issues

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Helsinki agreement

Informed consent

Investigational Review Board (IRB)

HIPAA deidentification and reidentification of patients and patient privacy

Regulatory Issues and Pathways in Clinical Trials

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The 1572 form and investigator responsibilities

Investigational new drug (IND) application

Investigational new drug or device exemption

510K pathway

Designing Clinical Trials

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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

Composite endpoints

Surrogate endpoints

Sample size and power calculations

Protocol creation

Abbreviations used in clinical trials

Operationalizing Clinical Trials

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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 (CEC)

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 the 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

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Cleaning a dataset

Summary statistics

Intent to treat versus modified intent to treat versus as treated

Student's t tests and analysis of variance (ANOVA)

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

How to write a manuscript

Meta-analysis

Positive publication bias

Study Tools

Bleeding:  ACUITY HORIZONS bleeding criteria  ●  Bleeding Academic Research Consortium  ●  CURE bleeding criteria  ●  GRACE bleeding criteria  ●  GUSTO bleeding criteria  ●  PLATO bleeding criteria  ●  STEEPLE bleeding criteria  ●  TIMI bleeding criteria

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Calculators:  GFR calculation ●  Wells score calculation ●  Caprini score calculation ●  CHA2DS2-VASc score calculation ●  DAPT score calculation ●  TIMI risk score calculation

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Differential Diagnosis:  D/D of Anemia ●  D/D of CK elevation ●  D/D of Chest Pain

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Other:  Abbreviations ●  Hy's law

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Risk Score:  GRACE risk score ●  TIMI risk score

Course Slides

Download the slides here:

• Lecture 1: Introduction to Clinical Trials & Study Design
• Lecture 2: Early Phase Clinical Trials
• Lecture 3: Phase 2 Studies and Moving From Phase 2 to Phase 3
• Lecture 4: Dose Finding Studies
• Lecture 5: Phase II Trial Design