Textbook of clinical trials: Difference between revisions
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HIPAA reidentification of patients and patient privacy | HIPAA reidentification of patients and patient privacy | ||
'''Regulatory issues and pathways in clinical trials''' | '''Regulatory issues and pathways in clinical trials''' | ||
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[[510K Pathway|510K pathway]] | [[510K Pathway|510K pathway]] | ||
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'''Designing Clinical Trials''' | '''Designing Clinical Trials''' | ||
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[[Phase II clinical trial|Phase 2 trials]] | [[Phase II clinical trial|Phase 2 trials]] | ||
Advancing from phase 2 to a phase 3 trial | Advancing from phase 2 to a phase 3 trial | ||
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[[Stratification]] | [[Stratification]] | ||
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[[Primary end point|Primary endpoint]] | [[Primary end point|Primary endpoint]] | ||
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[[Abbreviations used in clinical trials]] | [[Abbreviations used in clinical trials]] | ||
'''Operationalizing Clinical Trials''' | '''Operationalizing Clinical Trials''' | ||
Principal investigator role | Principal investigator role | ||
Executive committee role | Executive committee role | ||
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Nurse coordinator clinical research associate role | Nurse coordinator clinical research associate role | ||
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Monitor role | Monitor role | ||
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[[Randomization]] | [[Randomization]] | ||
[[Blinding]] | [[Blinding]] | ||
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[[Electronic data capture|Electronic data collection]] | [[Electronic data capture|Electronic data collection]] | ||
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Schedule of events | Schedule of events | ||
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Protocol adherence | Protocol adherence | ||
Storage and handling of investigational product | Storage and handling of the investigational product | ||
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Data management and designing an electronic data capture form | Data management and designing an electronic data capture form | ||
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Study completion and close out | Study completion and close out | ||
Protocol amendments | Protocol amendments | ||
Publication committee | Publication committee | ||
'''Statistical Analysis of Clinical Trials''' | '''Statistical Analysis of Clinical Trials''' | ||
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[[Student's t-test|Student's t tests]] and [[analysis of variance]] | [[Student's t-test|Student's t tests]] and [[analysis of variance]] | ||
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[[Chi-square test|Chi square analysis]] and [[Fisher's exact test]] | [[Chi-square test|Chi square analysis]] and [[Fisher's exact test]] | ||
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Net clinical benefit analyses | Net clinical benefit analyses | ||
Cost effectiveness analyses | Cost effectiveness analyses | ||
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Interim analyses and [[Futility in clinical research|futility analyses]] | Interim analyses and [[Futility in clinical research|futility analyses]] | ||
Reporting results | Reporting results | ||
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How to write a manuscript | |||
[[Meta-analysis]] | [[Meta-analysis]] |
Revision as of 14:01, 25 October 2019
Ethical Issues Helsinki agreement 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 |
Designing Clinical Trials Randomized controlled trials versus observational studies Pharmacokinetic (PK) and pharmcodynamic (PD) assessment Advancing from phase 2 to a phase 3 trial Parallel versus dose escalation studies |
Secondary endpoints and exploratory endpoints Sample size and power calculations 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 |
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 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 Cleaning a dataset Summary statistics Intent to treat versus modified intent to treat versus as treated |
Chi square analysis and Fisher's exact test 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 Positive publication bias
Study Tools GFR calculationTIMI Risk ScoreGrace Risk Score |