Experimental Drug Trials Conducted Outside U.S., Canada Raise Ethical, Scientific Standard Questions
STAT: It’s not just one suspect herpes vaccine trial: Most experimental drugs are tested offshore — raising concerns about data
“…The globalization of clinical trials has brought new treatments to historically neglected populations and generated data more representative of the world’s diversity. But the change has not come without side effects: Companies, researchers, and regulators are increasingly grappling with cultural differences — and more seriously, lapses in ethical and scientific standards — that sometimes arise when trials are conducted in countries without a strong tradition of robust clinical research. And those lapses can have serious consequences for the data that’s used to support medical decision-making…” (Robbins, 9/8).