A study of trial recruitment in developing Europe and a news story from India highlight issues of data quality and ethics in offshore trials. The two reports show the difference between investigators and sponsors seeking to run their trials using volunteers whose participation is informed versus those who see a guinea pig roundup as an early step in the drug development process.
Executives surveyed by Cutting Edge Research identify trial data quality among the benefits of using Central and Eastern European sites. They rank the region an eight on a scale of 10 in terms of the "rigor and quality" of physicians leading trials there. "These standards are a critical consideration because loose adherence to safety and data reporting requirements can jeopardize trial results and mislead drug development teams about the benefits and side effects of new products," according to the report. It finds also that emerging Europe's investigator standards are approaching those of researchers in established European markets.
In India, by contrast, a public health insurance plan for the poor appears to have become a recruitment source. Hospitals that serve Arogyasri plan subscribers, many uneducated and with poor literacy skills, are offering up their patient rolls for big pharma trials. Their recruitment successes--in terms of both speed and numbers--is raising questions about how much subjects understand about what's being done to them.
The Times of India quotes one researcher: "Getting a signature on the consent form is not difficult. If it takes a year to get 10 patients to volunteer for a trial in the U.S., here the same number can be arranged in no time."
Doctors are well compensated for the clinical trial work beyond their hospital salaries. Hospitals are using the growing opportunity to runs trials as an incentive in physician hiring.
- here's the Cutting Edge release
- see the ToI story