Survey - Lack of Confidence in Clinical Trial Data Delaying Drug Development

Applied Clinical Trials

Clinical data challenges are hindering pharmaceutical companies' abilities to bring more drugs to the market faster. These challenges were addressed with a study commissioned by Oracle Health Sciences and conducted by Pharma Intelligence.

To begin, the survey revealed that 57 percent of the clinical researchers believe that their clinical data issues result in trial delays. In addition to trial delays, 81 percent of respondents cited data governance issues as the biggest challenge in meeting regulatory compliance which include duplicate data/inconsistent data, data quality, and data integrity/traceability.

When asked what the top three operational challenges were with their clinical trial data, 51 percent cited data completeness, 45 percent said data quality and 43 percent, data cleaning. Not surprisingly, over three-fourths of respondents cited inconsistent data and missing patient data as the most critical clinical data problems to catch in clinical trials.

To conclude, the top three risks highlighted by the research include the need for additional data reconciliation; incomplete data to determine efficacy and patient replacements.

Read the full release here.