Regulatory Focus™ > News Articles > Study: No Regional Differences in Trial Data Quality

Study: No Regional Differences in Trial Data Quality

Posted 13 July 2012 | By Alexander Gaffney, RAC 

New recently-published research has found "no significant differences" in the quality of data generated at clinical trials sites around the world.

The data, published in the Drug Information Journal and supplied by the Association of Clinical Research Organizations (ACRO), looked at 26 "large-scale" clinical trials taking place at more than 4,700 research sites and involving more than 63,000 participants.

The study specifically looked at query rates-"generated when a discrepancy is noted between protocols or source data and the case report forms," explained study authors Panjak Desai, Christopher Anderson and William Sietsema.

"The calculated mean query rates and database change rates were compared using parametric and nonparametric statistical approaches," they wrote. "None of these approaches revealed statistically significant differences in the query rates or the rate of database change when each region was compared to North America or Western Europe."

"Thus, a comparative assessment of query rates suggests that the quality of clinical trials conducted in emerging countries is consistent with those conducted in developed regions," the authors concluded. "[The] findings should alleviate some concerns regarding clinical studies conducted in emerging nations."

The authors also noted four limitations of their study: query rates being dependent on the complexity of a given trial, an imbalance in regional trial representation, the lack of details regarding what each query entailed, and the limitations of query rates themselves in determining the quality of a trial. While they said none of these seemed likely to derail the results of their study, they were nevertheless planning follow-up validation studies aimed at reducing their impact.

"Overall, given the large number of trials, participants, sites, and therapeutic areas included in this analysis, this study represents a major attempt for the evaluation of clinical trials data quality for studies conducted outside mature regions (North America, Western Europe, and Japan)," concluded the authors.

Read more:

DIJ - A Comparison of the Quality of Data, Assessed Using Query Rates, From Clinical Trials Conducted Across Developed Versus Emerging Global Regions

Regulatory Focus newsletters

All the biggest regulatory news and happenings.