Applied Clinical Trials-09-01-2004

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.

Interspond’s RxPaging, Scientific Software Tools, Inc.’s VISTA, and Jurilab’s DrugMEt.

I've recently reviewed many articles on subject recruitment, retention, and attrition in clinical trials. I have found the same three basic research methods: surveys (by telephone and in person), interviews, and focus groups. The information gathered from the three methods include demographics, willingness to participate, problems experienced in clinical trials, motivations for volunteering, health behaviors, social support, benefit expectations, and understanding of the research project. But such strategies collect only the most superficial data, so we don't know nearly as much about the clinical trial experience as we need to know.

The protocol should describe the minimization process and processes to minimize systematic bias, as this can influence practical aspects of the study.

The EU Clinical Trials Directive may raise particular concerns for those considering running studies in CEE.

The EU’s newest draft legislation contains GCP rules that somehow aren’t already law.

FDA encourages clinical data e-submission and boosting development of new therapies to combat bioterrorism, cancer, and obesity.