The analysis - published in the current edition of the Drug Information Journal – examined what impact location has on the number of database queries – which are generated when a discrepancy is noted between protocol or source data and the case report forms (CRFs)
Lead author Pankaj Desai from the Drug Development Graduate Program, University of Cincinnati collected query data from 26 large Phase II and III trials conducted in multiple regions by members of US industry group, the Association of Clinical Research Organizations (ACRO).
Analysis of the nearly 1.39 million queries, 7.5 million CRF pages and 95 million data parameters revealed that there was no statistical differences between trials carried out in emerging regions with those in Europe or North America.
Desai wrote that: “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.
“Despite several limitations of our analyses and the multifaceted complexities of global clinical trials, our findings should alleviate some concerns regarding clinical studies conducted in emerging nations.”
ACRO not surprised
The finding was welcomed by ACRO executive director Doug Peddicord who said: "Clinical research has become a global enterprise, largely driven by the CRO industry, and thus we have an obligation to study the issues that affect data quality and research ethics globally,” adding that "we are very pleased, but not surprised, by the findings of Dr. Desai's article."
Peddicord also implied that regulators concerned that trials in emerging markets are of a lesser quality than those in the US and Europe should take note of the findings.
"The FDA, EMA and other regulators are very focused on issues surrounding global clinical trials. ACRO's approach is to provide unbiased, reliable data that addresses any concerns regulators, research sponsors or patients may have.
“We are currently conducting a follow-up study analyzing global quality at the research site level with metrics such as protocol deviations.”