On the Use of Local Assessments for Monitoring Centrally Reviewed Endpoints with Missing Data in Clinical TrialsReportar como inadecuado




On the Use of Local Assessments for Monitoring Centrally Reviewed Endpoints with Missing Data in Clinical Trials - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Due to ethical and logistical concerns itis common for data monitoring committees to periodically monitor accruingclinical trial data to assess the safety, and possibly efficacy, of a newexperimental treatment. When formalized, monitoring is typically implementedusing group sequential methods. In some cases regulatory agencies have requiredthat primary trial analyses should be based solely on the judgment of anindependent review committee IRC. The IRC assessments can producedifficulties for trial monitoring given the time lag typically associated withreceiving assessments from the IRC. This results in a missing data problemwherein a surrogate measure of response may provide useful information forinterim decisions and future monitoring strategies. In this paper, we presentstatistical tools that are helpful for monitoring a group sequential clinicaltrial with missing IRC data. We illustrate the proposed methodology in the caseof binary endpoints under various missingness mechanisms including missingcompletely at random assessments and when missingness depends on the IRC’smeasurement.

KEYWORDS

Group Sequential; Information; Independent Review; Endpoint; Missing Data

Cite this paper

S. Brummel and D. Gillen -On the Use of Local Assessments for Monitoring Centrally Reviewed Endpoints with Missing Data in Clinical Trials,- Open Journal of Statistics, Vol. 3 No. 4A, 2013, pp. 41-54. doi: 10.4236-ojs.2013.34A005.





Autor: Sean S. Brummel, Daniel L. Gillen

Fuente: http://www.scirp.org/



DESCARGAR PDF




Documentos relacionados