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===[[Textbook of clinical trials|Back to top]]===
===[[Textbook of clinical trials|Back to top]]===


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


'''Helsinki agreement]]'''
[[Informed consent]]


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


==== [[Institutional Review Board|Investigational Review Board]] ([[IRB]]) ====
HIPAA reidentification of patients and patient privacy


==== HIPAA reidentification of patients and patient privacy ====




Line 17: Line 17:


=== '''Regulatory issues and pathways in clinical trials''' ===
=== '''Regulatory issues and pathways in clinical trials''' ===
[[Form 1572|The 1572 form and investigator responsibilities]]


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


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


==== [[Investigational new drug or device exemption]] ====
[[510K Pathway|510K pathway]]


==== [[510K Pathway|510K pathway]] ====






===  '''Designing Clinical Trials''' ===
===  '''Designing Clinical Trials''' ===
[[Randomized controlled trials]] versus [[observational studies]]


==== [[Randomized controlled trials]] versus [[observational studies]] ====
[[Phase I trial|Phase 1 trials]]


==== [[Phase I trial|Phase 1 trials]] ====
[[Pharmacokinetic]] (PK) and pharmcodynamic (PD) assessment
[[Pharmacokinetic]] (PK) and pharmcodynamic (PD) assessment


==== [[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


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


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


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


==== [[Stratification]] ====
[[Primary end point|Primary endpoint]]


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


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


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


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


==== [[Protocols|Protocol creation]] ====
[[Abbreviations used in clinical trials]]
[[Abbreviations used in clinical trials]]


Line 61: Line 64:


===  '''Operationalizing Clinical Trials''' ===
===  '''Operationalizing Clinical Trials''' ===
Principal investigator role


==== Principal investigator role ====
Executive committee role


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


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


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


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


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


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


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


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


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


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


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


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


==== Identification of sites ====
[[Randomization]]


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


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


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


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


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


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


==== Clinical event committee or event adjudication committee ====
Adverse events, serious adverse events and serious unexpected events


==== Adverse events, serious adverse events and serious unexpected events ====
Data safety monitoring board (DSMB)


==== Data safety monitoring board (DSMB) ====
Study drug discontinuation, withdrawal of consent, incomplete follow up and lost to follow up patients


==== Study drug discontinuation, withdrawal of consent, incomplete follow up and lost to follow up patients ====
Protocol adherence


==== Protocol adherence ====
Storage and handling of investigational product


==== Storage and handling of investigational product ====
Data management and designing an electronic data capture form


==== Data management and designing an electronic data capture form ====
Source documents


==== Source documents ====
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''' ===
Cleaning a dataset


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


==== Summary statistics ====
[[Intention to treat analysis|Intent to treat]] versus [[Modified intention to treat analysis|modified intent to treat]] versus as treated


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


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


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


==== [[Logistic regression]] ====
[[Multivariate analysis|Multivariate modeling]]


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


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


==== Handling [[missing data]] ====
Subgroup and [[Interaction (statistics)|interaction analyses]]


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


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


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


==== Quality adjusted life year analyses ====
Interim analyses and [[Futility in clinical research|futility analyses]]


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


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


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


==== Positive publication bias ====




Revision as of 13:39, 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


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

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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