Monitoring eCOA/ePRO Data to Improve Data Quality and Reduce Trial Risk Reg


Medidata Detect: Monitoring eCOA/ePRO Data to Improve Data Quality and Reduce Trial Risk White Paper

Despite the scientific rigor that the pharmaceutical industry has applied to generating quality data throughout the clinical trial process, data quality issues still arise—sometimes with drastic consequences.

  • Nearly a quarter (24 percent) of applications to regulators require one or more resubmissions before approval.
  • Over half (52 percent) of resubmissions that are eventually approved resulted from inconsistent study results, either across endpoints, sites, or studies.
  • The first unsuccessful submission adds a median delay of 435 days to the approval process.*

How can Sponsors operationalize a patient-centric approach into their drug development plans? In this paper, we discuss the value of using advanced technology—specifically centralized statistical analytics—to oversee patient safety and data quality/integrity in a risk-based manner. Relying on centralized statistical analytics will help ensure the quality of eCOA/ePRO data and compliance with ICH and FDA regulations on the use of risk-based monitoring.

*. Sacks LV, Shamsuddin HH, Yasinskaya YI, Bouri K, Lanthier ML, Sherman RE,“Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012.” JAMA.2014;311(4):378–384. doi:10.1001/ jama.2013.282542