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biodoc

04/21/18 8:53 PM

#225533 RE: Scottwny #225531

Scottwny, it sure seems like it wouldn't be that hard but apparently it's not easy.

https://www.clinicalleader.com/doc/a-critical-juncture-for-clinical-trial-data-management-0001

The average cycle times to build and to lock the study database are long, with no observed improvement over the past decade. The average time to build and release a study database is 68 days, and the average time from a study’s last patient, last visit (LPLV) to database lock is 36 days. These average cycle times are consistent with other published and anecdotal reports.



biodoc

frrol

04/21/18 10:16 PM

#225550 RE: Scottwny #225531

Retail investors always need to keep in mind that the "top line" results we see are the tip of the iceberg. There is supporting PK/PD data, all the trial protocols, patient specs, etc. They have to be regressed, analyzed, double-checked. I've gotten glimpses into the process and it's surprisingly complex (though it shouldn't be). As evidence, note that data and conclusions will continue to dribble out for our B-OM trial; witness the recent release of the B-OM sub-grouping. This information you would think would pop out from the first regressions. In fact it may have, but needed to be verified and refined.