Textbook of clinical trials: Difference between revisions
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===[[Textbook of clinical trials|Back to top]]=== | ===[[Textbook of clinical trials|Back to top]]=== | ||
'''Ethical Issues''' | |||
'''Helsinki agreement]]''' | |||
==== [[Informed consent]] | ==== [[Informed consent]]''' | ||
==== [[Institutional Review Board|Investigational Review Board]] ([[IRB]]) ==== | ==== [[Institutional Review Board|Investigational Review Board]] ([[IRB]]) ==== | ||
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==== HIPAA reidentification of patients and patient privacy ==== | ==== HIPAA reidentification of patients and patient privacy ==== | ||
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==== [[510K Pathway|510K pathway]] ==== | ==== [[510K Pathway|510K pathway]] ==== | ||
=== '''Designing Clinical Trials''' === | === '''Designing Clinical Trials''' === | ||
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==== [[Protocols|Protocol creation]] ==== | ==== [[Protocols|Protocol creation]] ==== | ||
[[Abbreviations used in clinical trials]] | [[Abbreviations used in clinical trials]] | ||
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==== Publication committee ==== | ==== Publication committee ==== | ||
=== '''Statistical Analysis of Clinical Trials''' === | === '''Statistical Analysis of Clinical Trials''' === | ||
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==== Positive publication bias ==== | ==== Positive publication bias ==== | ||
=== '''Study Tools''' === | === '''Study Tools''' === | ||
Revision as of 13:35, 25 October 2019
Back to top
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