Analysis of data query as parameter of quality

Area of Science:

• Clinical data management
• Pharmaceutical research
• Biostatistics

Background:

• Data query (DQ) rate per case record form (CRF) page is a critical indicator of clinical trial data quality.
• Factors such as clinical trial phase, therapeutic area, and investigator site location can influence DQ rates.

Purpose of the Study:

• To compare data query rates per page across different countries, clinical trial phases, and therapeutic areas.
• To identify specific factors contributing to variations in data quality.

Main Methods:

• Analysis of data from 19 paper CRF clinical trials involving 5,610 patients across 352 sites.
• Double data entry was used to generate data queries.
• Parametric (ANOVA) and nonparametric (Kruskal-Wallis, median test) statistical analyses were employed for comparisons, with Tukey's Studentized Range Test for multiple comparisons.

Main Results:

• A total of 33,177 DQs were generated from 108,599 CRF pages (0.306 DQ/CRF page).
• Significant differences in DQ rates per page were observed between phases, countries, and therapeutic areas.
• Phase I showed significantly different DQ rates compared to other phases. Oncology, cardiology, endocrinology, and dermatology also exhibited significant differences.

Conclusions:

• Study phase and therapeutic area are significant determinants of data quality, as indicated by data query rates.
• Understanding these variations is crucial for implementing targeted data quality improvement strategies in clinical trials.