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Abstract:
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Global trials are becoming increasingly common, with many moving into the "ascending markets" of Eastern Europe, Asia, and Latin America. This trend is occurring for many reasons, including the need for a) larger and more rapidly conducted trials, b) drug-naïve populations, c) lower operating costs of running the trials, and d) the opportunity to build relationships with clinicians in other regions who may eventually prescribe the drug studied in the trial. These global trials introduce many new issues that must be considered in designing, conducting, analyzing and interpreting the trials, including heterogeneity of populations and cultures, standards of care, regulatory and ethical standards, etc. We will discuss the issues that must be considered in planning and carrying out these trials. This is a forum for discussion and sharing experiences in conducting these trials.
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