Textbook of clinical trials: Difference between revisions
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'''Ethical Issues''' | '''Ethical Issues''' | ||
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[[510K Pathway|510K pathway]] | [[510K Pathway|510K pathway]] | ||
'''Designing Clinical Trials''' | '''Designing Clinical Trials''' | ||
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[[Inclusion criteria|Inclusion]] and [[exclusion criteria]] | [[Inclusion criteria|Inclusion]] and [[exclusion criteria]] | ||
[[Stratification]] | [[Stratification]] | ||
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Nurse coordinator clinical research associate role | Nurse coordinator clinical research associate role | ||
Monitor role | Monitor role | ||
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[[Electronic data capture|Electronic data collection]] | [[Electronic data capture|Electronic data collection]] | ||
Schedule of events | Schedule of events | ||
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Storage and handling of the investigational product | Storage and handling of the investigational product | ||
Data management and designing an electronic data capture form | Data management and designing an electronic data capture form | ||
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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]] | ||
(ANOVA) | (ANOVA) | ||
[[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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Reporting results | Reporting results | ||
How to write a manuscript | How to write a manuscript | ||
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[[The GRACE risk score|Grace Risk Score]] | [[The GRACE risk score|Grace Risk Score]] | ||
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Revision as of 15:30, 25 October 2019
Ethical Issues
Helsinki agreement
Investigational Review Board (IRB)
HIPAA deidentification and 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
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
Inclusion and exclusion criteria
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
Recruitment of study participants
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
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
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