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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