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<div style="-moz-column-count:4; column-count:4;">
===[[Textbook of clinical trials|Back to top]]===
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=== '''Ethical Issues''' ===


==== [[Helsinki agreement]] ====
'''Ethical Issues'''
----
[[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 deidentification and reidentification of patients and patient privacy|HIPAA deidentification and reidentification of patients and patient privacy]]


{{ColBreak}}
'''Regulatory Issues and Pathways in Clinical Trials'''
----
[[Form 1572|The 1572 form and investigator responsibilities]]


[[Investigational new drug application|Investigational new drug (IND) application]]


=== '''Regulatory issues and pathways in clinical trials''' ===
[[Investigational new drug or device exemption]] 


==== [[Form 1572|The 1572 form and investigator responsibilities]] ====
[[510K Pathway|510K pathway]]


==== [[Investigational new drug application|Investigational new drug (IND) application]] ====
'''Designing Clinical Trials'''
----
[[Randomized controlled trials]] versus [[observational studies]]


==== [[Investigational new drug or device exemption]] ====
[[Phase I trial|Phase 1 trials]]


==== [[510K Pathway|510K pathway]] ====
[[Pharmacokinetic]] (PK) and [[Pharmacodynamic assessment|pharmcodynamic (PD) assessment]]


{{ColBreak}}
[[Phase II clinical trial|Phase 2 trials]]


===  '''Designing Clinical Trials''' ===
[[Advancing from phase 2 to a phase 3 trial]]


==== [[Randomized controlled trials]] versus [[observational studies]] ====
[[Phase III trials|Phase 3 trials]]


==== [[Phase I trial|Phase 1 trials]] ====
[[Parallel versus dose escalation studies]]
[[Pharmacokinetic]] (PK) and pharmcodynamic (PD) assessment


==== [[Phase II clinical trial|Phase 2 trials]] ====
[[Hypothesis|Hypothesis generation]]
Advancing from phase 2 to a phase 3 trial


==== [[Phase III trials|Phase 3 trials]] ====
[[Inclusion criteria|Inclusion]] and [[exclusion criteria]]
[[Parallel study|Parallel]] versus dose escalation studies


==== [[Hypothesis|Hypothesis generation]] ====
[[Stratification]]


==== [[Inclusion criteria|Inclusion]] and [[exclusion criteria]] ====
[[Primary end point|Primary endpoint]]


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


==== [[Primary end point|Primary endpoint]] ====
[[Composite endpoint |Composite 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]]
{{ColBreak}}


'''Operationalizing Clinical Trials'''
----
[[Principal investigator role]]


===  '''Operationalizing Clinical Trials''' ===
[[Executive committee role]]


==== Principal investigator 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 status|Recruitment of study participants]]


==== [[Blinding]] ====
[[Electronic data capture|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 (CEC)]]


==== Concomitant medications ====
[[Adverse events, serious adverse events and serious unexpected events]]


==== Clinical event committee or event adjudication committee ====
[[Data safety monitoring board (DSMB)]]


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


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


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


==== Protocol adherence ====
[[Database|Data management]] and [[Electronic data capture|designing an electronic data capture form]]


==== Storage and handling of investigational product ====
[[Source document|Source documents]]


==== Data management and designing an electronic data capture form ====
[[Study closeout|Study completion and close out]]


==== Source documents ====
[[Protocol amendment|Protocol amendments]]


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


==== Protocol amendments ====
'''Statistical Analysis of Clinical Trials'''
----
[[Data cleansing|Cleaning a dataset]]


==== Publication committee ====
[[Summary statistics]]


{{ColBreak}}
[[Intention to treat analysis|Intent to treat]] versus [[Modified intention to treat analysis|modified intent to treat]] versus as treated


===  '''Statistical Analysis of Clinical Trials''' ===
[[Student's t-test|Student's t tests]] and [[analysis of variance|analysis of variance (ANOVA)]]


==== Cleaning a dataset ====
[[Chi-square test|Chi square analysis]] and [[Fisher's exact test]]


==== Summary statistics ====
[[Logistic regression]]


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


==== [[Student's t-test|Student's t tests]] and [[analysis of variance]] ====
[[Survival analysis]]


==== [[Chi-square test|Chi square analysis]] and [[Fisher's exact test]] ====
[[missing data|Handling missing data]]


==== [[Logistic regression]] ====
[[Subgroup analysis|Subgroup]] and [[Interaction (statistics)|interaction analyses]]


==== [[Multivariate analysis|Multivariate modeling]] ====
[[Net clinical benefit|Net clinical benefit analyses]]


==== [[Survival analysis]] ====
[[Cost-effectiveness analysis|Cost effectiveness analyses]]


==== Handling [[missing data]] ====
[[Quality-adjusted life year|Quality-adjusted life year analyses]]


==== Subgroup and [[Interaction (statistics)|interaction analyses]] ====
[[Interim analysis|Interim analyses]] and [[Futility in clinical research|futility analyses]]


==== Net clinical benefit analyses ====
[[Reporting results]]


==== Cost effectiveness analyses ====
[[How to write a manuscript]]


==== Quality adjusted life year analyses ====
[[Meta-analysis]]


==== Interim analyses and [[Futility in clinical research|futility analyses]] ====
[[Publication bias|Positive publication bias]]
</div>


==== Reporting results and how to write a manuscript ====
==Study Tools==
<div style="font-family: Arial; font-size: 13px; width: 60%;">
'''Bleeding:'''&nbsp;
[[ACUITY HORIZONS bleeding criteria]] &nbsp;●&nbsp; 
[[Bleeding Academic Research Consortium]] &nbsp;●&nbsp;
[[CURE bleeding criteria]] &nbsp;●&nbsp;
[[GRACE bleeding criteria]] &nbsp;●&nbsp;
[[GUSTO bleeding criteria]] &nbsp;●&nbsp;
[[PLATO bleeding criteria]] &nbsp;●&nbsp;
[[STEEPLE bleeding criteria]] &nbsp;●&nbsp;
[[TIMI bleeding criteria]]
----
'''Calculators:'''&nbsp;
[[Glomerular filtration rate|GFR calculation]]&nbsp;●&nbsp;
[[Wells score for PE (modified)|Wells score calculation]]&nbsp;●&nbsp;
[[Caprini score|Caprini score calculation]]&nbsp;●&nbsp;
[[CHA2DS2-VASc Score|CHA2DS2-VASc score calculation]]&nbsp;●&nbsp;
[[DAPT score|DAPT score calculation]]&nbsp;●&nbsp;
[[TIMI Risk Score for STEMI|TIMI risk score calculation]]
----
'''Differential Diagnosis:'''&nbsp;
[[Anemia|D/D of Anemia]]&nbsp;●&nbsp;
[[Creatine kinase|D/D of CK elevation]]&nbsp;●&nbsp;
[[Chest pain differential diagnosis|D/D of Chest Pain]]
----
'''Other:'''&nbsp;
[[Abbreviations]]&nbsp;●&nbsp;
[[Hy's law]]
----
'''Risk Score:'''&nbsp;
[[The GRACE risk score|GRACE risk score]]&nbsp;●&nbsp;
[[TIMI Risk Score|TIMI risk score]]
</div>


==== [[Meta-analysis]] ====
==Course Slides==
 
'''Download the slides here:'''<br>
==== Positive publication bias ====
===[[Media:Clinical Research Course Syllabus as of 4.9.21.pdf|Clinical Research Course Syllabus]]===
{{ColBreak}}
{| class="wikitable"
 
|+
===  '''Study Tools''' ===
!Lecture
 
!Topic
==== [[GFR|GFR calculation]] ====
!Presenter
 
|-
==== [[TIMI risk score|TIMI Risk Score]] ====
|Lecture 1
 
|[[Media:Why do we randomize patients (1).ppt| Introduction to Clinical Trials & Study Design]]
==== [[The GRACE risk score|Grace Risk Score]] ====
|C. Michael Gibson
|-
|Lecture 2
|[[Media:Where innovation goes to die updated.ppt|Description of Trial Phases - I]]
|C. Michael Gibson
|-
|Lecture 3 and 4
|[[Media:Phase 2.ppt|Description of Trial Phases - II]]
|C. Michael Gibson
|-
|Lecture 5
|[[Media:DoseFindingStudy V3.ppt|Study Design - I]]
|Gerald Chi
|-
|Lecture 6
|[[Media:(Serge Korjian).pptx|Study Design II]]
|Serge Korjian
|-
|Lecture 7
|[[Media:Phase 3 Design.pptx|Study Design Part III]]
|Arzu Kalayci
|-
|Lecture 8
|[[Media:PERFUSE Clinical Trial Course - Protocol 1of4 wo Notes.pptx|Clinical Trial Protocol Lecture 1 of 4]]
|Clara Fitzgerald
|-
|Lecture 9
|[[Media:CTC Randomization AKK.PPTX|Developing a Study Protocol - II]]
|Arzu Kalayci
|-
|Lecture 10
|[[Media:Data Collection v2.pptx|Developing a Study Protocol - III]]
|Gerald Chi
|-
|Lecture 11
|[[Media:PERFUSE Clinical Trial Course - Protocol Amendments 1.19.21.pptx|Part 1:Clinical Trial Protocol Violations & Amendments]]
[[Media:Intro to Observational Studies & Cohort 1.19.21.pptx|Part 2: Introduction to Observational Studies and Cohort]]
|Clara Fitzgerald
|-
|Lecture 12
|[[Media:Cross-sectional study v2.pptx|Cross-sectional studies]]
|Gerald Chi
|-
|Lecture 13
|[[Media:ExploratoryDataAnalysis.ppt|Exploratory Data Analysis: A statistician perspective]]
|Gheorghe Doros
|-
|Lecture 14
|[[Media:Power v2.pptx|Statistical Perspective II: power and sample size]]
|Gerald Chi
|-
|Lecture 15
|[[Media:Association OR RR v2.pptx|Statistical Perspective III: measures of association]]
|Gerald Chi
|-
|Lecture 16
|[[Media:CTC Regression AKK.pptx|Statistical Perspective IV: Overview of regression models]]
|Arzu Kalayci
|-
|Lecture 17
|[[Media:PERFUSE Clinical Trial Course - Ethics Part 1 Posted.pptx|Ethics of clinical trial I]]
|Clara Fitzgerald
|-
|Lecture 18
|[[Media:PERFUSE Clinical Trial Course - Ethics Part 2.pptx|Ethics of clinical trial II]]
|Sonia Ammu
|-
|Lecture 19
|[[Media:PERFUSE Clinical Trial Course Running a Clinical Trial Part 1.pptx|Running a Clinical Trial part I & II]]
|Maria Ok
|-
|Lecture 20
|[[Media:PERFUSE Clinical Trial Course GxP and Audits 09Apr2021.pptx|Running a Clinical Trial part III]]
|Danielle Feingold
|-
|Lecture 21
|[[Media:Importance of Missing Data and Patient Retention by C Michael Gibson.pptx|Importance of missing data]]
|C. Michael Gibson
|-
|Lecture 22
|[[Media:The Role of AROs In Clinical Research Don Cutlip April 2021.pptx|The Role of Academic Research Organizations in Clinical Research Sponsor]]
|Donald E. Cutlip
|-
|Lecture 23
|[[Media:PERFUSE Clinical Trial Course - Clinical Events Committee (CEC).pptx|Clinical Event Committee]]
|David Weiss
|-
|Lecture 24
|[[Media:Ciaranca, Sam DMC Overview Final 11MAY2021.pptx|Data Review Committee III, Data and Safety Monitoring Board]]
|Sam Ciaranca
|-
|Lecture 25
|[[Media:PERFUSE Clinical Trial Course - Role of the PI.PPTX|The role of the principal investigator in clinical trials]]
|Clara Fitzgerald
|-
|Lecture 26
|[[Media:CTC Authorship AKK.PPTX|Authorship]]
|Arzu Kalayci
|-
|Lecture 27
|[[Media:PERFUSE Clinical Trial Course - presentation of data.pptx|Presentation of data]]
|Clara Fitzgerald
|-
|Lecture 28
|[[Media:Interpretation.zip|Interpretation of the data]]
|Gerald Chi
|-
|Lecture 29
|[[Media:FW Clinical Research Course Suggestions.zip|Visual abstract]]
|Sadaf Sharfaei
|}

Latest revision as of 19:05, 6 July 2021

Ethical Issues

Helsinki agreement

Informed consent

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

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

Composite 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 (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

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

How to write a manuscript

Meta-analysis

Positive publication bias

Study Tools

Bleeding:  ACUITY HORIZONS bleeding criteria  ●  Bleeding Academic Research Consortium  ●  CURE bleeding criteria  ●  GRACE bleeding criteria  ●  GUSTO bleeding criteria  ●  PLATO bleeding criteria  ●  STEEPLE bleeding criteria  ●  TIMI bleeding criteria

Calculators:  GFR calculation ●  Wells score calculation ●  Caprini score calculation ●  CHA2DS2-VASc score calculation ●  DAPT score calculation ●  TIMI risk score calculation

Differential Diagnosis:  D/D of Anemia ●  D/D of CK elevation ●  D/D of Chest Pain

Other:  Abbreviations ●  Hy's law

Risk Score:  GRACE risk score ●  TIMI risk score

Course Slides

Download the slides here:

Clinical Research Course Syllabus

Lecture Topic Presenter
Lecture 1 Introduction to Clinical Trials & Study Design C. Michael Gibson
Lecture 2 Description of Trial Phases - I C. Michael Gibson
Lecture 3 and 4 Description of Trial Phases - II C. Michael Gibson
Lecture 5 Study Design - I Gerald Chi
Lecture 6 Study Design II Serge Korjian
Lecture 7 Study Design Part III Arzu Kalayci
Lecture 8 Clinical Trial Protocol Lecture 1 of 4 Clara Fitzgerald
Lecture 9 Developing a Study Protocol - II Arzu Kalayci
Lecture 10 Developing a Study Protocol - III Gerald Chi
Lecture 11 Part 1:Clinical Trial Protocol Violations & Amendments

Part 2: Introduction to Observational Studies and Cohort

Clara Fitzgerald
Lecture 12 Cross-sectional studies Gerald Chi
Lecture 13 Exploratory Data Analysis: A statistician perspective Gheorghe Doros
Lecture 14 Statistical Perspective II: power and sample size Gerald Chi
Lecture 15 Statistical Perspective III: measures of association Gerald Chi
Lecture 16 Statistical Perspective IV: Overview of regression models Arzu Kalayci
Lecture 17 Ethics of clinical trial I Clara Fitzgerald
Lecture 18 Ethics of clinical trial II Sonia Ammu
Lecture 19 Running a Clinical Trial part I & II Maria Ok
Lecture 20 Running a Clinical Trial part III Danielle Feingold
Lecture 21 Importance of missing data C. Michael Gibson
Lecture 22 The Role of Academic Research Organizations in Clinical Research Sponsor Donald E. Cutlip
Lecture 23 Clinical Event Committee David Weiss
Lecture 24 Data Review Committee III, Data and Safety Monitoring Board Sam Ciaranca
Lecture 25 The role of the principal investigator in clinical trials Clara Fitzgerald
Lecture 26 Authorship Arzu Kalayci
Lecture 27 Presentation of data Clara Fitzgerald
Lecture 28 Interpretation of the data Gerald Chi
Lecture 29 Visual abstract Sadaf Sharfaei
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