“A formal statistical evaluation indicates no significant differences in data quality for clinical trials conducted in developing regions relative to mature regions,” says an article published in the July 2012 issue of the Drug Information Journal. The article by Pankaj B. Desai, PhD, of the Drug Development Graduate Program, College of Pharmacy at the University of Cincinnati, analyzed 26 large-scale multi-regional Phase II/III clinical trials enrolling nearly 64,000 participants at more than 4,700 research sites.
Members of the Association of Clinical Research Organizations contributed data covering 10 regions and multiple therapeutic areas. The study compared query rates and database changes, which are accepted measures for assessing clinical trial data quality. The study’s overall data set included 1.39 million queries on 7.5 million pages of case report forms on over 95 million data parameters. ACRO provided funding for the project.
“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,” said ACRO Executive Director Doug Peddicord, PhD. “We are very pleased, but not surprised, by the findings of Dr. Desai’s article.”
The primary focus of the study was to compare the quality of data from clinical trials conducted in developing regions to that from North America. No statistical differences in query rates between these regions and North America were observed. Potential shortcomings of the study include limited data from some regions (China and Japan) and the possibility that several factors may impact the overall quality of clinical trials conducted in different parts of the globe. However, the study provides an initial indication that the data quality from developing regions such as India, Eastern Europe or Latin America is consistent with the quality from the United States and Canada.
Peddicord concluded: “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. Our mission is to ensure clinical trials are conducted to the highest standards of quality and human subject protections wherever they occur so that regulators and patients may be confident in the results presented.”
Drug Information Journal, a peer-reviewed scholarly publication, is the official publication of the Drug Information Association (www.diahome.org).
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics and medical devices. The association provides an active voice for the CRO industry globally. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 75,000 professionals worldwide and annually conduct more than 11,000 clinical trials involving nearly two million participants in 115 countries. For more information, please visit www.acrohealth.org. Twitter @acrohealth. YouTube @ACROHealthChannel.Business Wire
Last updated on: 12/07/2012