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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Participant Flow Module
Results Database Train-the-Trainer Workshop
September 2015
http://ClinicalTrials.gov
FDAAA 801 - Participant Flow
“A table…, including the number of patients
who dropped out of the clinical trial and the
number of patients excluded from the
analysis, if any.”
[Sec. 282(j)(3)(C)(i)]
2FDAAA 801 = Section 801 of the Food and Drug Administration Amendments Act of 2007
ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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CONSORT Flow Diagram
©2010 by British Medical Journal Publishing Group
Shulz KF, Altman DG, Moher D. BMJ 2010;340:698-702.
Results: NCT00137969
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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Results: Participant Flow
Publication (CONSORT Flow Diagram)
Adapted from Merrill JT et al. Arthrit Rheum 2010 and NCT00137969
ClinicalTrials.gov
Period 1: 52 Weeks
Placebo +
Prednisone
Rituximab +
Prednisone
STARTED 88 169
COMPLETED 64 120
NOT COMPLETED 24 49
Adverse Event 13 19
Patients’ Decision 5 11
Physicians’ Decision 4 13
Lost to Follow-up 2 3
Death 0 3
Web Site Resourceshttp://www.clinicaltrials.gov/ct2/manage-recs/how-report
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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Participant Flow Templatehttp://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html
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Participant Flow Checklisthttp://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html
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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Best Practices
• Specific Periods to reflect study design and
to account for number of participants
starting and completing each Period
• Use of Milestones to convey key events
– e.g., number of participants that received the
assigned intervention
• Provide Reasons for Non-completion
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Participant FlowTutorial
ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Record Summary: Enter Results
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Add Results Section
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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Results Section
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Select Participant Flow Arms/Groups
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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Edit Participant Flow Arms/Groups
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Edit Participant Flow
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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Edit Participant Flow (cont.)
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Edit Participant Flow (cont.)
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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Edit Participant Flow (cont.)
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Edit Participant Flow (cont.)
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ClinicalTrials.gov Results Database
Train-the-Trainer Workshop
September 2015
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Participant Flow Overview
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Enter Participant Flow
• Example Study Designs
– Factorial
– Crossover
– Cluster Randomized
– Dose Escalation
– Multiple Period
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