(Total Views: 510)
Posted On: 04/01/2020 10:59:00 AM
Post# of 154064
I agree that 2-3 weeks is too optimistic
Reasons
- Hospitals need their IRB’s (Institutional review boards) approval - should come fast considering the trial
- Patients need to pass the inclusion/exclusion criteria and sign the informed consent
- drug needs to be delivered including the placebo
- even if 30 enroll each day - which is a high number ( depending on how many sites are enrolling ) you have 10 days for full enrollment
- study is 14 days and days is collected (manually) along the way
- data needs to be sent to Amarex and entered into their data Mgmt system
- data need to be reviewed (case report forms frequently have some errors - especially with very busy hospitals) which lead to something called queries that the hospital needs to answer
- once data is cleaned it needs to be database locked - this does happen until last patient data is in and cleaned
- then the statisticians analyze the data
- the. It needs to be put into the fda submission format and we all know now long that takes
- then FDA reviews, asks questions and then Renders a decision
All this happens when some orgs are working with reduced staff and Perhaps from homes rather than office.
This is all In normal times - there may be expediting factors from fdA
The interim data review that happens with a small group part way through is key if the unblinded data shows statistically significant improvement and good safety
IMO
Hope this helps
Reasons
- Hospitals need their IRB’s (Institutional review boards) approval - should come fast considering the trial
- Patients need to pass the inclusion/exclusion criteria and sign the informed consent
- drug needs to be delivered including the placebo
- even if 30 enroll each day - which is a high number ( depending on how many sites are enrolling ) you have 10 days for full enrollment
- study is 14 days and days is collected (manually) along the way
- data needs to be sent to Amarex and entered into their data Mgmt system
- data need to be reviewed (case report forms frequently have some errors - especially with very busy hospitals) which lead to something called queries that the hospital needs to answer
- once data is cleaned it needs to be database locked - this does happen until last patient data is in and cleaned
- then the statisticians analyze the data
- the. It needs to be put into the fda submission format and we all know now long that takes
- then FDA reviews, asks questions and then Renders a decision
All this happens when some orgs are working with reduced staff and Perhaps from homes rather than office.
This is all In normal times - there may be expediting factors from fdA
The interim data review that happens with a small group part way through is key if the unblinded data shows statistically significant improvement and good safety
IMO
Hope this helps
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