Overseas Clinical Trials: legal, regulatory, ethical and cultural questions

Here are two bioindustry lawyers, writing in Bioworld: What to Think About When Considering an Overseas Clinical Trial Program

To remain competitive, drug, device and biotechnology companies must continually pursue innovative new products and product improvements. Clinical trials are essential to the development of new medical products and require the investment of tremendous time and resources — with no guarantee of success. In 2007, biotechnology and pharmaceutical companies spent approximately $58.8 billion on research and development efforts, with clinical trials typically consuming 40 percent or more of the research and development budget.

This enormous investment in time and money has caused drug companies to explore opportunities to lower the costs and shorten the timelines of their clinical trial programs. It is, therefore, no surprise that pharmaceutical companies in the U.S. have steadily increased the number of clinical trials they conduct overseas, with a focus on jurisdictions promising cost savings and recruitment efficiencies, such as those located in Central and Eastern Europe (CEE). While U.S. companies can realize significant benefits by conducting a clinical trial in the CEE and other foreign jurisdictions, they also must consider the myriad of legal, regulatory, ethical and cultural questions they will invariably encounter in setting up and conducting a clinical trial abroad. U.S. companies also must be aware that FDA is increasing its scrutiny of foreign clinical trial data. In April 2008, FDA amended its foreign clinical trial regulations to ensure "the quality and integrity of foreign clinical data supporting FDA decision making on product applications and to help ensure the protection of human subjects participating in foreign clinical trials...."

For those of us who are outsider observers of the bio-pharma industry, it's useful to see discussions among insiders once in a while.