EPITARGET is also anticipating the future challenges and requirements in a larger-scale preclinical harmonization of epilepsy studies, including training, data management expertise, cost, location, data safety and continuity of data repositories during and after funding period, and incentives motivating for the use of CDEs.
The decision to end the study came on May 31, in a periodic look at its accumulating data by an expert panel, the data safety and monitoring board.
The work [19] proposes eight general rules that hold for data stream processing; but the most important rules related to our work are: "keeping the data moving", "generating predictable outcomes", "guarantying data safety and availability", and "processing and respond instantaneously".
Every 6 months during the study, a data safety and monitoring board reviewed all patients' data in an unblinded fashion.
However, sharing sensitive medical image data to a third party demands protection of the data itself to ensure data safety and patient privacy.
An independent data safety and monitoring board reviewed the data and performed a pre-specified blinded interim analysis midway through the trial.
Sharing such sensitive data demands proper protection to ensure data safety and maintain patient privacy.
This includes having a steering committee that defines inclusion and exclusion criteria, randomization, blinding, placebo control, central monitoring and data management, as well as a data safety and monitory board managed by a preclinical research organization (pCRO).
The limitations of the study by Nseir and coworkers [ 1] underscore the need for larger collaborative national and international networks to develop well-designed trials, with independent data analysis and data safety monitoring boards, that would greatly increase our understanding of disease pathogenesis, prevention, and treatment.
