Global trials fall short on ethical standards
Pharmaceutical companies are increasingly conducting clinical trials in developing countries, but many are using questionable practices, according to an article in Science.
Conducting trials in global settings could save time and money. Target patient numbers can be met faster, and speeding up drug development can earn companies an extra year of patent exclusivity.
The countries themselves also stand to gain money and staff training for hospitals, medical schools and research organisations.
In particular, the number of trials carried out in China and India is growing, but both countries have shortcomings in trial know-how and ethical oversight.
A recent study revealed that only 207 of 2,235 'randomised' trials reported in Chinese publications were appropriately randomised. And in India, most potential investigators lack the appropriate skills to undertake these trials.
Patients are frequently manipulated into participating in trials, with widespread illiteracy making it easy to sidestep informed-consent procedures, and sponsors frequently tempt would-be participants with massive payments and expensive medications.
To combat dubious ethics, journal editors in both countries have agreed to report only trials that are publically registered before they begin.
Registries and journal policies are a start towards helping ethical oversight keep up with the developing world's growing participation in clinical trials, Chinese and Indian scientists say.