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1. Emergency Unblinding Procedure
Emergency unblinding should only be
considered when knowledge of the treatment allocation will significantly influence
a participant�s clinical management.
If unblinding is necessary, the treatment allocation should only be shared
with personnel directly involved with the unblinding request. Unless
medically required, the investigator and site staff should always remain blinded.
What about a request from HREC?
If there is a request to
unblind from a HREC to assist with a causality assessment, then the site should
not perform the unblinding themselves but instead notify the TGI Project
Team. This way the unblinded statistician can send the unblinded status
directly to the Ethics Committee and ensure that the investigator remains
blinded.
The allocation should not be disclosed to any site staff, nor should there
be any written or verbal disclosure of the treatment allocation in any of
the corresponding patient documentation.
2. Patient
Population - Quality over Quantity
While some patients may meet all
eligibility criteria, it�s crucial to establish whether a patient is able
to commit to the study procedure including all the follow-up visits for the
duration of the trial. Without this knowledge, we increase the potential
for Lost To Follow Up and in turn, reduce the
accuracy of the trial.
To assess whether a
patient can commit to the study, sites can use the below example questions
during a screening visit:
1.
Are you
available for in-clinic
follow-up visits?
2.
Is the distance
from where you live to the clinic manageable?
3.
Do you
have access to a reliable mode of transport?
4.
Are there
any reasons that you feel may prevent or make it difficult to commit to the
duration of the study?
To ensure continued participation in the
trial over the entire study duration, TRACK sites can implement the below
strategies:
Clear & regular communication
During the consent process, ensure
participants know what to expect by thoroughly explaining what is required
of them, length of the trial, and likely experiences with the study drug.
Encourage participants to ask questions and make sure they feel comfortable
to reach out if needed.
Showing appreciation
Participants are more likely to stay in
the trial if they feel their efforts are appreciated. For this reason, it�s
important to let the participant know how important and impactful their
participation is.
Be considerate of participant�s time
Inconvenient visit scheduling can lead to
higher drop-out rates. In-clinic visits should be completed on the same day
as usual dialysis sessions or clinical appointments.
Having alternative contact options
A participant may not be able to attend a
clinic visit for many reasons, such as being unwell, not having access to
transport, or even bad weather. If a clinic visit cannot be done in person,
let the participant know the visit can be completed remotely either by
phone or video call, and that the study medication can be shipped to them
after the call.
Individual risk-based strategies
If a participant has
discontinued the drug or is regularly missing visits, it�s important that
the participant is put in contact with the principal investigator to
communicate why their participation is important, as there may be
alternative follow-up options.
3. Outcome
Reporting
Any SAE that is listed as a study-specific
outcome is to be collected on the Outcome eCRF only within 7
days of becoming aware of the event/ discharge from hospital. Events that
fall into this category do
not require the SAE eCRF to be completed.
If a participant experiences a SAE and passes away as a result, then 2
separate forms should be completed in the study database:
1.
Initial SAE recorded either on SAE eCRF or Outcome eCRF
2.
Death on an Outcome eCRF
If for example, a participant has a stroke and
dies 2 weeks later, the stroke should be entered in the Outcome eCRF and
the subsequent death on a separate Outcome eCRF.
It�s important to note that eCRFs should reflect the current status
of an event. If a participant experiences a SAE that is �ongoing� but then
later dies, then the event status on the SAE eCRF should be updated to
�fatal� and an Outcome eCRF should be completed.
We urge sites to check before reporting whether an event is listed in the
TRACK protocol as a study-specific outcome or should be reported as an SAE.
Making sure this process is followed each time will help to protect the
integrity of study data.
General Reminders:
�
Review of outcomes required at every visit
�
All outcomes experienced by participants must be
reported regardless of where the participant was treated for the outcome
�
Please allow some extra time and effort to track
all outcomes if participants do not routinely return to the study site for
all medical treatment.
�
Please continue to follow up any LTFU participants as
if they are deceased as this may be a study outcome
�
Outcome Definitions can be found in Appendix 1 of the
TRACK Protocol: TRACK Trial Endpoint Definitions (page 59)
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