Sergei Varshavsky

Sergei Varshavsky, MD, PhD, is chairman and CEO, EVIDENCE Clinical and Pharmaceutical Research, Los Altos, CA.

The first U.S. investigational new drug (IND) clinical trials outside of the United States were conducted in Europe in the late 1970s. In the early 1990s, Central and Eastern Europe (CEE), Latin America, Asia, and selected countries on the African continent (mostly South Africa) became involved in clinical trials.

Clinical trials sponsors seek quick subject enrollment and high data quality, expressed by both strict adherence to good clinical practice (GCP) requirements and completeness and correctness of the data collected from investigative sites. However, the most informative sources of detailed information on data quality such as site monitoring visit reports, sponsor, and CRO audit reports are maintained as strictly confidential documents and are not publicly disseminated. Therefore, a substantial proportion of the information on data quality in clinical research that is available to the general public is based on anecdotal reports rather than well-referenced and organized observations. The U.S. Food and Drug Administration found no evidence of poor GCP compliance during inspections in the emerging clinical research countries, including Eastern Europe and the former Soviet Union.^1-2