Dear UCSF Clinical Research Community,
We hope you are staying safe and enjoying the transition to the autumn season. The fourth edition of our newsletter will help you to successfully submit study results by addressing common issues we encounter as UCSF’s ClinicalTrials.gov Protocol Registration and Results System (PRS) administrators.
After reading this newsletter, please consider completing a short survey to help us improve our content and for a chance to win an Amazon.com gift card!
An archive of our newsletter is available on the UCSF Clinical Research Resource HUB.
As the UCSF PRS administrators, we often encounter outcome measures that are incorrectly formatted for ClinicalTrials.gov. The purpose of the ClinicalTrials.gov outcome measures is to report summary quantitative results by group for enrolled participants. Outcome measures are required to clearly and accurately describe what will be measured and reported.
Outcome measures
Each outcome measure must represent a single variable, with a single unit of measure.
The outcome measure must include a description of what will be measured. Outcome measures are not used to explain the goal, aim, or objective of an assessment or of the study itself.
The outcome measure language must be outcome neutral, language such as “change” must be used instead of “improvement,” “decrease,” etc.
Titles:
Each title must be brief but descriptive, specific, and unique, conveying what will be measured and reported as data for the study.
For change measures, the title must specify that a change will be measured over time. PRS does not permit the use of general titles such as “Safety,” “Feasibility,” or “Pharmacokinetics.”
Descriptions:
Use the description field to include any additional information about the measure, such as how the measure will be taken, relevant definitions, criteria, and the method of assessment.
When a score on a scale will be reported, include the unabbreviated scale title, how the reported score is calculated, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Time Frames:
The time frames must be the specific time point at which the outcome will be measured from the perspective of a single participant from baseline (the time of enrollment) or the duration of time of assessment of the participant.
Change measures must specify two time points for which the change is being measured (e.g., baseline and 8 weeks).
If an outcome measure will be reported at multiple time points, each time point must be entered as a separate outcome measure. (Dose escalation studies are an exception, see example below.)
Examples of acceptable outcome measures:
Title: Mean Change from Baseline to 6 months in Pain Scores on the Visual Analog Scale
Description: Pain Scores will be measured on the Visual Analog Scale (VAS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain.
Time Frame: Baseline and 6 months
Title: Change in Mean Sitting Systolic Blood Pressure (SBP)
Description: Blood pressure will be assessed after the participant was in a seated position for at least 5 minutes. Blood pressure will be measured with an automated measurement device 3 times at 1-2 minute intervals. A mean of the 3 measurements will be calculated.
Time Frame: Baseline and 2 weeks
Title: Percentage of Implant Sites with Bleeding on Probing
Description: Bleeding on probing (BOP) is a measure of gingival inflammation and tissue destruction. Bleeding sites were identified by gently probing the base of the implant site and assigning a score of 0 (no bleeding) or 1 (bleeding). Percentage of BOP = 100% * (total implant sites that bled) / (total number of implants).
Time Frame: 12 months
Title: Area Under the Concentration-Time Curve (AUC 0-72h)
Description: Blood samples were obtained and plasma concentrations were determined using a validated high-pressure liquid chromatography method.
Time Frame: Prior to the initial dose on day 1 and 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 16, 24, 36, 48 and 72 hours post-dose
Title: Median Overall Survival (OS)
Description: OS is measured as the time from the first treatment received by the participant until death or study closure. Participants lost to follow-up will be censored at time of last contact by the study team.
Time Frame: Up to 5 years
We recommend reviewing the PRS Entering Outcome Measures Information guided tutorial and the ClinicalTrials.gov Protocol Registration Quality Control Review Criteria (pg. 6) for more information on the outcome measures, and prior to creating a study record on ClinicalTrials.gov.
Please reach out to us if you have any questions regarding the outcome measures, or anything relating to ClinicalTrials.gov. We are always happy to help.
Please complete a short survey about this newsletter by Monday, October 4, and enter to win 1 of 3 $25 Amazon.com gift cards.
If you are a researcher affiliated with the Helen Diller Family Comprehensive Cancer Center, please contact Julie Robbins for assistance with ClinicalTrials.gov.
Warm wishes,
Ruby and Melanie