Clinical Trial Data Snafus Attract Unwanted FDA Attention

In New Survey, Nearly 60% of Clinical Researchers Blame Data Management Hurdles for Trial Delays

In New Survey, Nearly 60% of Clinical Researchers Blame Data Management Hurdles for Trial Delays

Persistent clinical trial data management problems are slowing trials, sparking U.S. Food and Drug Administration (FDA) audit findings and 483s, and putting patients at risk. That’s the grim assessment of clinical researchers in a new survey report from Oracle Health Sciences and Pharma Intelligence.

Nearly 60% of clinical researchers said data management hurdles had delayed their trials, and more than 40% said it was causing them to miss “critical trial issues that put patients or the trial at risk.” More than one-third of respondents said they’d been hit with unwanted FDA attention as a result, while 34% experienced an increase in the “number of resources/costs to manage and clean data.”

Astonishingly, 32% said the problems were so bad it forced them to re-run a trial. An equal percentage said they’d endured submission rejects because of data-handling problems.

More than 80% of clinical researchers cited governance as the biggest challenge in meeting regulatory compliance. Here’s how they ranked their top data issues:

  • Data quality (30%)
  • Duplicate/inconsistent data (26%)
  • Data lineage/traceability (25%)
  • Access to data (16%)

“Data governance is our top concern because clinical data quality issues can hinder a trial’s completion,” Melonie Longan, director of data operations and functional services at CRO Premier Research, said in the Oracle Report, “Challenges and Opportunities in Clinical Data Management.”

Asked to name their top three operational challenges when handling clinical trial data, just over half cited data completeness, 45% said data quality, while 43% cited data cleaning.

Respondents also expressed concern about catching critical data snafus before they occur. Over 75% of respondents cited inconsistent data as the most processing problem. Others problem areas cited included:

  • Missing patient data (77%)
  • Patients missing visits (44%)
  • Out of range data (e.g., the patient is listed as 250 years old) (39%)
  • Patient should not have been enrolled in the trial at the outset (28%)

“Clinical researchers shouldn’t have to spend time and resources on fixing data issues that technology was built to handle,” said Steve Rosenberg, general manager of Oracle Health Sciences.

Author: Michael Causey