entering results - harvard catalyst · entering results a case study using the ards network alta...
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ENTERING RESULTS
A CASE STUDY USING THE
ARDS Network ALTA TRIAL
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CASE STUDY OVERVIEW
Run through each of the components that
comprise the results section in Clinical
Trials.gov
Use entries from the ARDSNet ALTA trial
Give content and data entry perspectives
Share some lessons learned
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8 RESULTS COMPONENTS
1. Point of contact
2. Agreements
3. Enrollment
4. Participant Flow
5. Baseline Characteristics
6. Outcome Measures
7. Limitations & Caveats
8. Adverse Events
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ALTA STUDY SUMMARY
Design: randomized, Phase II/III placebo-controlled
clinical trial of a 2-agonist for tx of acute lung injury
(ALI)
Population/Tx: mechanically ventilated patients with
ALI received Albuterol or placebo for up to 10 days
Primary Outcome: ventilator free days (VFDs)
Results: VFDs were not sig different
(means of 14.4 & 16.6; 95% CI for the difference,
- 4.7 to 0.3 d; p=0.087)
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ENROLLMENT
Target or actual number enrolled
Type (anticipated vs. actual)
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ALTA ENROLLMENT
Change to actual
number enrolled
Changed from
“anticipated”
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PARTICPANT FLOW DATA
Recruitment Details
Key information
relevant to the
recruitment process for
the overall study
Example: dates of the
recruitment period and
types of location (e.g.,
medical clinic), to
provide context.
Pre-assignment Details
Any significant events
and approaches for the
overall study (e.g.,
wash out, run-in,
transition)
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ALTA PARTICIPANT FLOW
DATA
Enter reason for any
values not zero
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BASELINE
CHARACTERISTICS
A table of demographic and baseline data
For the entire trial population
For each arm
Age and gender are required
Can also add study specific measures
Population description
Explanation of how number of participants for
analysis was determined
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ALTA BASELINE CHARACTERISTICS
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ALTA BASELINE CHARACTERISTICS
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ALTA BASELINE CHARACTERISTICS
Report a measure of
central tendency and
dispersion for each arm
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OUTCOME MEASURES
A table of values for each outcome measure
by arm
Data for each is displayed as a separate table
Based on outcomes entered when the study
was registered
TIP: CT.gov requires results for every
variable entered; don’t enter any that will not
be analyzed
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ALTA EXAMPLE
Phase II endpoint: number of AEs &
proportion of subjects with dose reduction
This endpoint was included as part of the
protocol info at registration
Got “stuck” when entering results
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OUTCOME MEASURE
Name and description of the measure used to
assess the effect of the experimental
variables
Data Required:
Type
Title
Description
Time frame
Assessed for safety?
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ALTA OUTCOME MEASURE
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OUTCOME MEASURE DATA
Measure type (select 1):
Number
Measure of central tendency for continuous
measures (from pick list)
Measure of dispersion/precision
from pick list
Unit of measure
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ALTA OUTCOME DATA
Mean
Standard Error
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ALTA OUTCOME DATA
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SECONDARY OUTCOME WITH
STATISTICAL ANALYSIS
Outcome: Mortality Prior to Hospital Discharge With Unassisted Breathing to
Day 60
Statistical
reporting
optional
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LIMITATIONS & CAVEATS
Describe any limitations of the trial
Examples:
Early termination leading to small numbers of
subjects analyzed
Technical problems with measurement leading to
unreliable or uninterpretable data.
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ADVERSE EVENTS
What to report?
Summary of AEs (divided into 2 tables):
All SAEs
“Other” events
Report all that exceed a frequency threshold of
5% in any arm
ALTA: not reported this way; had to create a
new dataset
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ALTA SAE DATA
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ALTA OTHER AEs
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ADVERSE EVENTS
How to enter it into CT.gov?
Website is set up to enter each event
separately
Now allows download or upload using tab
delimited files
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ENTERING AE DATA
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HELP: Results Data Element
Definitions
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TAKE HOME MESSAGE
Outcome measures need to be analyzed and include a results variable
Preview results requirements and create required data tables at the same time as final analysis
Use upload/download feature to enter multiple AE records
“Basic Results” Data Element Definitions are helpful