As globalization increases in clinical research, so, too, have concerns over the quality of work coming from developing countries. In an effort to lay those concerns to rest, the University of Cincinnati and the Association of Clinical Research Organizations (ACRO) conducted a study, which they say showed no difference in the quality of data drawn from more than 4,700 sites around the world.
While the study showed data quality from places like India, Eastern Europe and Latin America is on-par with Canada and the U.S., ACRO admits that the study isn't perfect. Study authors had limited data to work with from China (a big power player in outsourcing) and Japan. They also admit the possibility of "several factors" impacting the quality of clinical trials, like investigator training and regulatory oversight, according to John Lewis, ACRO's vice president of public affairs.
What the study doesn't offer is a look at ethical dilemmas CROs can face. An investigative story on Indian CROs from NBC's "Dateline" highlighted that problem, showing two small CROs willing to test a copy of the controversial and deadly drug Vioxx on patients, with little concern for their health. The study fails to depict what builds up to the data, but ACRO is in the midst of conducting another on protocol deviations, Lewis told FierceCRO.
Another point worth noticing is that all study participants are ACRO members, which could draw a red flag. Still, ACRO stands by its choice. "We think our members are representative of what's going on globally," Lewis said.
- here's a statement from ACRO
- check out the study (PDF)