I have the great privilege of working on the Oxford #COVID19 vaccine trials
Safety is the top concern in all vaccine trials, and we go to great lengths to ensure the vaccine is safe to use, and to keep our trial participants safe
Here are some of the ways we do that
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Safety is the top concern in all vaccine trials, and we go to great lengths to ensure the vaccine is safe to use, and to keep our trial participants safe
Here are some of the ways we do that
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First we have a dedicated phone number our participants can phone 24hrs a day, 365 days a year with ANY medical concerns that gets them straight to a study doctor
We provide advice, direct them to appropriate care, and record ALL symptoms/events in our participants
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We provide advice, direct them to appropriate care, and record ALL symptoms/events in our participants
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All participants have symptom diaries they complete in the period following vaccination
We receive alerts if any serious symptoms are recorded so we can follow up with them, check they're OK, and review if they were related to the vaccine (some mild side effects are normal)
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We receive alerts if any serious symptoms are recorded so we can follow up with them, check they're OK, and review if they were related to the vaccine (some mild side effects are normal)
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We conduct frequent face to face reviews with the participants to check their diaries and ask them about anything they may have forgotten to tell us about
If they took paracetamol for a headache, it gets recorded
Antihistamine for sneezing, gets recorded
Everything
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If they took paracetamol for a headache, it gets recorded
Antihistamine for sneezing, gets recorded
Everything
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What if something serious happens?
If a patient is hospitalised FOR ANY REASON (fell down the stairs, anaphylaxis to a bee, hernia repair etc) we review ALL the details of the admission and speak directly to the study sponsor within 24hrs
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If a patient is hospitalised FOR ANY REASON (fell down the stairs, anaphylaxis to a bee, hernia repair etc) we review ALL the details of the admission and speak directly to the study sponsor within 24hrs
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Some stuff is totally obviously unrelated (e.g. car accident)
For other stuff, we speak to the medical specialists looking after the patient and the study sponsor to discuss any possibility it could be related to the vaccine
The majority of the time, it is *very* unlikely
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For other stuff, we speak to the medical specialists looking after the patient and the study sponsor to discuss any possibility it could be related to the vaccine
The majority of the time, it is *very* unlikely
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If there are concerns it *could* be related, the studies STOP until their dedicated safety monitoring team can collect and review all the relevant information to ensure they are happy the study is safe to continue
These reviews are extremely rigorous
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These reviews are extremely rigorous
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In a trial with 10's of 1000's of patients, it is common for them to pause for review of medical events which may have happened anyway, regardless of the participant being in the trial
But no one takes chances. Safety comes first, and we work hard to ensure it's safe.
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But no one takes chances. Safety comes first, and we work hard to ensure it's safe.
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