Publication bias originates primarily with the investigators, and sponsors performing trials who decide whether to submit their trial for publication.
The problems related to placebo treatment are supported by thorough criticism of trialists and sponsoring companies performing placebo-controlled trials in the prophylaxis of postoperative nausea and vomiting [ 13, 14] – trials that all provided sufficient antiemetic rescue medications for all participants!
The safety committee from the sponsor performed ongoing blinded safety surveillance.
The study sponsor performed the monitoring of the study, data management, statistical analyses and study report writing.
The sponsor performed a literature search and identified and presented a total of ten studies that they considered were relevant to the decision problem.
There was no indication that the sponsor performed a literature search for existing economic papers that might inform the decision problem, and no economic studies were supplied.
The sponsor performed a basic literature search which did not identify any economic studies relevant to the decision problem (i.e., they cited no studies which used the WatchBP Home A device).
This guideline included a recommendation that sponsors perform a meta-analysis of the important CV events across phase 2 and phase 3 controlled clinical trials, and explore similarities and/or differences in subgroups (eg, age, sex, race), if possible.
For the most recent 510(k) clearance of a CA-125 device (Dimension Vista® LOCI CA 125 Flex® Reagent Cartridge), the sponsor performed a retrospective study on 330 frozen specimens taken from 75 subjects during follow-up surveillance for ovarian cancer progression [ 86].
In addition, the sponsors performed deterministic sensitivity analysis where the usage of VibraTip™ was assumed to be 20 or 100%%, and this was combined with a second sensitivity analysis, whereby an assumption was made that the introduction of VibraTip™ was associated with a 1 % reduction in ulcer formation (which was applied to the transitional probabilities used in the decision tree).
