|
1. December DSMB Update
The Data Safety Monitoring Board (DSMB) is
an independent committee that maintains the safety of trial participants by
meeting regularly to review safety and efficacy data. The DSMB provides
recommendations to the TRACK Global Steering Committee (GSC) to guide the
progress of the trial.
In the new year, investigators will
be brought together on a regional or country level to receive updates and
discuss study progress. We thank all who made efforts to clean up data
queries and resolve overdue visits in the lead-up to the DSMB meeting.
DSMB Report
The latest TRACK DSMB
Meeting was held Tuesday 5th December, using data extracted
on the 16th November, at which point
951 patients were randomised. Key highlights:
�
MACE
primary outcome rate of 8.9
for per 100 person years (py).
�
Total of 91 patients have
experienced a primary outcome.
�
Total
number of Serious Adverse Events (SAEs) 307 (176/951 patients).
Please see
below the recommendations of the DSMB:
2. Data Management
As we approach 1000
participants, our dataset becomes larger and more challenging to manage.
Our thanks extended again to those who put efforts towards resolving
queries in the lead up to the end of the year. Data quality assurance is
key to ensuring the integrity and success of the TRACK trial. Alongside
ensuring that the details entered into the
database are accurate, it is also essential to resolve queries on a regular
basis to avoid accumulation of issues.
General Reminders:
�
Queries to be resolved within 5-10 days of their
creation. Please resolve existing queries, with priority to oldest entries
as well as those regarding eligibility
or outcome
reporting.
�
Tracking of outcomes is essential, check for events
that occur outside of study site or in LTFU participants.
�
Outcome Definitions can be found in Appendix 1 of the
TRACK Protocol: TRACK Trial Endpoint Definitions (page 59)
|
