February 2024 SOCRA Source Journal - Journal - Page 36
[Time frame: 3 months, 6
months, and 12 months]
ClinicalTrials.gov wants each
time frame listed separately:
“Number of Participants with
Serious Adverse Events (SAEs).
An SAE is any untoward
medical occurrence that at
any dose results in death,
are life threatening, requires
hospitalization or prolongation
of hospitalization or results in
disability/incapacity.
[Time frame: 3 months]
“Number of Participants with
Serious Adverse Events (SAEs).
An SAE is any untoward
medical occurrence that at
any dose results in death,
are life threatening, requires
hospitalization or prolongation
of hospitalization or results in
disability/incapacity.
[Time frame: 6 months]
“Number of Participants with
Serious Adverse Events (SAEs).
An SAE is any untoward
medical occurrence that at
any dose results in death,
are life threatening, requires
hospitalization or prolongation
of hospitalization or results in
disability/incapacity.
[Time frame: 12 months]
Example #8
The Primary Outcome stated:
“Each participant was asked to
indicate his or her current level
of pain.”
ClinicalTrials.gov wants specific
data about the level of pain:
“Each participant was asked to
indicate his or her current level
of pain on a 100 mm scale. 0
mm indicates no pain and 100
mm indicates the worst pain
imaginable.”
36
Example #9
Secondary Outcome,
Supplemental Opioid Use,
stated:
“Participants were allowed
to take opioids in addition to
either study treatment. The
values reported represent
the amount morphine (in mg/
kg) equivalent to the amount
of concomitant opioid pain
medication used by the
participants.”
The Outcome Measure table
describing the arms and the
drugs stated:
“Unit of measure:
concentration”
In the real-world, it is necessary
to measure in g/kg and the unit
of measurement.
“Participants were allowed
to take opioids in addition to
either study treatment. The
values reported represent the
amount morphine (in mgkg)
equivalent to the amount
of concomitant opioid pain
medication used by the
participants.”
The Outcome Measure table
describing the arms and the
drugs should state:
“Unit of measure: in mg/kg”
Example #10
The Secondary Outcome, Time
to Perceptible Pain Relief,
stated:
“Patients were given a
stopwatch at the start of
treatment and asked to
document the time, in minutes,
until they first detected an
improvement (lessening)
in the amount of pain they
were experiencing. There
was no significant difference
in the amount of time it took
participants who were treated
SOCRA SOURCE © May 2023
with ibuprofen and those who
were treated with placebo to
experience perceptible pain
relief (p = 0.08).”
ClinicalTrials.gov wants the
posting to include a table for
the Statistical Test of Hypothesis
and to state the threshold for
statistical significance under
Comments:
“Patients were given a
stopwatch at the start of
treatment and asked to
document the time, in minutes,
until they first detected an
improvement (lessening) in
the amount of pain they were
experiencing.”
“Statistical Test of Hypothesis
P-value0.08
Comments
The threshold for
statistical significance was p =
0.05.”
Example #11
The Secondary Outcome stated:
“Participants’ Overall
Assessment of Treatment
Each participant provided a
response to the question “How
effective do you think the study
medication is as a treatment for
pain?” Answers were reported
on a five-point scale:
1 = Poor,
2 = Fair,
3 = Good,
4 = Very good, and
5 = Excellent.”
ClinicalTrials.gov wants the title
to be:
“Number of Participants
Who Rated Effectiveness of
Treatment as Good, Very Good,
or Excellent”
“Each participant provided a
response to the question “How
effective do you think the study
medication is as a treatment for
pain?” Answers were reported
on a five-point scale were