Overseas regulators toughen clinical trial stance

The Wall Street Journal weighs in this morning with a feature looking at the increasingly tough stance overseas regulators are taking to the clinical trials being conducted around the world. India, for example, is probing the screening measures used in a vaccine trial after a baby in the study died. Polish investigators want to know why two seniors died while taking an experimental bird flu vaccine being developed by Novartis. Age limits should have excluded both from the study.

For drug developers, the investigations underscore a heightened awareness of the dangers inherent in every clinical trial. And in developing countries, there's a growing concern that their citizens are being used to test new drugs that will later be sold in more affluent markets. Developing nations offer a prime opportunity to lower development costs. And drug investigators also say it's easier to enroll patients abroad, where access to medications may be barred by high costs.

The WSJ notes that in 2005 some 40 percent of all clinical trials took place in low or middle-income countries.

- read the article in the Wall Street Journal

Suggested Articles

Bristol Myers Squibb and bluebird bio filed their BCMA-targeting CAR-T therapy for FDA approval, teeing it up for a potential green light in 2020.

With case counts surging and top officials infected, the U.K. is joining the testing for Gilead Sciences' much-hyped antiviral candidate remdesivir.

By redeploying staff, the FDA thinks it can respond to COVID-19-related requests and review protocols within 24 hours of receipt.