Textbook of clinical trials: Difference between revisions

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=== '''Ethical Issues''' ===


'''Ethical Issues'''
==== [[Helsinki agreement]] ====


[[Helsinki agreement]]
==== [[Informed consent]] ====


[[Informed consent]]
==== [[Institutional Review Board|Investigational Review Board]] ([[IRB]]) ====


[[Investigational Review Board (IRB)]]
==== [[HIPAA|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'''
==== [[Form 1572|The 1572 form and investigator responsibilities]] ====


[[The 1572 form and investigator responsibilities]]
==== [[Investigational new drug application|Investigational new drug (IND) application]] ====


[[Investigational new drug (IND) application]]
==== [[Investigational new drug or device exemption]] ====


Investigational new drug or device exemption
==== [[510(k)|510K pathway]] ====


510K pathway
===  '''Designing Clinical Trials''' ===


==== [[Randomized controlled trials]] versus [[observational studies]] ====


'''Designing Clinical Trials'''
==== [[Phase I trial|Phase 1 trials]] ====
 
[[Pharmacokinetic]] (PK) and pharmcodynamic (PD) assessment
Randomized controlled trials versus observational studies
 
Phase 1 trials  
 
Pharmacokinetic (PK) and pharmcodynamic (PD) assessment
 
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


Phase 3 trials
==== [[Phase III trials|Phase 3 trials]] ====
 
[[Parallel study|Parallel]] versus dose escalation studies
Parallel versus dose escalation studies
 
Hypothesis generation


Inclusion and exclusion criteria
==== [[Hypothesis|Hypothesis generation]] ====


Stratification
==== [[Inclusion criteria|Inclusion]] and [[exclusion criteria]] ====


Primary endpoint
==== [[Stratification]] ====


Secondary endpoints and exploratory endpoints
==== [[Primary end point|Primary endpoint]] ====


Surrogate endpoints
==== Secondary endpoints and [[Exploratory research|exploratory endpoints]] ====


Sample size and power calculations
==== [[Surrogate endpoint|Surrogate endpoints]] ====


Protocol creation
==== [[Sample size]] and [[Statistical power|power calculations]] ====


==== [[Protocols|Protocol creation]] ====
[[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


Steering committee role
==== Executive committee role ====


Nurse coordinator clinical research associate role
==== Steering committee role ====


Monitor role  
==== Nurse coordinator clinical research associate role ====


Sponsor role
==== Monitor role ====


Randomization service
==== Sponsor role ====


Central laboratory facility
==== Randomization service ====


EKG core laboratory
==== Central laboratory facility ====


Angiographic core laboratory
==== EKG core laboratory ====


MRI core laboratory
==== Angiographic core laboratory ====


Genetics core laboratory
==== MRI core laboratory ====


Biomarker core laboratory
==== Genetics core laboratory ====


Identification of sites
==== Biomarker core laboratory ====


Randomization
==== Identification of sites ====


Blinding
==== [[Randomization]] ====


Recruitment of study participants
==== [[Blinding]] ====


Electronic data collection
==== [[Recruitment status|Recruitment of study participants]] ====


Schedule of events
==== [[Electronic data capture|Electronic data collection]] ====


Concomitant medications
==== Schedule of events ====


Clinical event committee or event adjudication committee
==== Concomitant medications ====


Adverse events, serious adverse events and serious unexpected events
==== Clinical event committee or event adjudication committee ====
Data safety monitoring board (DSMB)


Study drug discontinuation, withdrawal of consent, incomplete follow up and lost to follow up patients
==== Adverse events, serious adverse events and serious unexpected events ====


Protocol adherence
==== Data safety monitoring board (DSMB) ====


Storage and handling of investigational product
==== Study drug discontinuation, withdrawal of consent, incomplete follow up and lost to follow up patients ====


Data management and designing an electronic data capture form
==== Protocol adherence ====


Source documents
==== Storage and handling of investigational product ====


Study completion and close out
==== Data management and designing an electronic data capture form ====


Protocol amendments
==== Source documents ====


Publication committee
==== Study completion and close out ====


==== Protocol amendments ====


'''Statistical Analysis of Clinical Trials'''
==== Publication committee ====


Cleaning a dataset
===  '''Statistical Analysis of Clinical Trials''' ===


Summary statistics
==== Cleaning a dataset ====


Intent to treat versus modified intent to treat versus as treated
==== Summary statistics ====


Student's t tests and analysis of variance
==== [[Intention to treat analysis|Intent to treat]] versus [[Modified intention to treat analysis|modified intent to treat]] versus as treated ====


Chi square analysis and Fisher's exact test
==== [[Student's t-test|Student's t tests]] and [[analysis of variance]] ====


Logistic regression
==== [[Chi-square test|Chi square analysis]] and [[Fisher's exact test]] ====


Multivariate modeling
==== [[Logistic regression]] ====


Survival analysis  
==== [[Multivariate analysis|Multivariate modeling]] ====


Handling missing data
==== [[Survival analysis]] ====


Subgroup and interaction analyses
==== Handling [[missing data]] ====


Net clinical benefit analyses
==== Subgroup and [[Interaction (statistics)|interaction analyses]] ====


Cost effectiveness analyses
==== Net clinical benefit analyses ====


Quality adjusted life year analyses
==== Cost effectiveness analyses ====


Interim analyses and futility analyses
==== Quality adjusted life year analyses ====


Reporting results and how to write a manuscript
==== Interim analyses and [[Futility in clinical research|futility analyses]] ====


Meta-analysis
==== Reporting results and how to write a manuscript ====


Positive publication bias
==== [[Meta-analysis]] ====


==== Positive publication bias ====


'''Study Tools'''
===  '''Study Tools''' ===


GFR calculation
==== [[GFR|GFR calculation]] ====


TIMI Risk Score
==== [[TIMI risk score|TIMI Risk Score]] ====


Grace Risk Score
==== [[The GRACE risk score|Grace Risk Score]] ====

Revision as of 19:55, 24 October 2019

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

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

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