But the Falcons are not equipped to handle deviations from the norm.
Today, Suzette is working at Intarcia Therapeutics Inc. as Senior Manager of the Quality Assurance Systems group, which handles deviations, corrective and preventive actions (CAPAs) and change controls.
This article provides an overview of the basic statistical approaches for analyzing clinical trials with binary, continuous or time-to-event outcomes as well as methods for handling protocol deviations due to noncompliance and early drop-out.
The control law is based on existing path-velocity control (PVC), or so called online time scaling, but in addition to speed adaptation along the tangent of the path, the algorithm also comprises an explicit formulation and approach, with several attractive properties, for handling the deviations along the transversal directions of the path.
*Among 43 trials that described methods of handling protocol deviations in publication.
The method of handling protocol deviations was described in 37 protocols and 43 publications.
†Among 32 trials that described methods of handling protocol deviations in both publication and protocol.
Overall, the primary method described for handling protocol deviations in the publication differed from that described in the protocol for 19/43 trials; table 4 provides details.
39 Previous reviews of high impact journals have found that a high proportion of publications provide insufficient details about methods of handling protocol deviations or missing data.
Unacknowledged discrepancies between protocols and publications were found for sample size calculations (18/34 trials), methods of handling protocol deviations (19/43) and missing data (39/49), primary outcome analyses (25/42), subgroup analyses (25/25), and adjusted analyses (23/28).
37 38 39 One study reported that the method described for handling protocol deviation was different from that described in the protocol in 19 of 43 trials examined.
