Infections inevitably occur in such trials, Dr. Gayle said.
In such trials, participants agree to receive either a sirolimus-coated stent or a standard stent.
As is standard practice in such trials, the women were split at random into two groups.
It also recommended that at least half the subjects in such trials be nonprisoners, making it more difficult to test products that might scare off volunteers.
The company does, however, have a drug in such trials -- an oral form of heparin, used to prevent blood clotting in heart patients.
The case is also likely to reprise a common accusation in such trials: that, too often, auditors and lawyers simply looked the other way.
In such trials, scientists randomly assign patients to treatment or control groups with the aim of eliminating bias from clinician and patient decisions.
Only three per cent of cancer patients in the United States are enrolled in such trials, which are typically conducted at academic medical centers.
Between 2007 and 2010, at least 1,730 people died in India while, or after, participating in such trials.
Participants in such trials are often those whose tumour has spread beyond its original site, and will probably prove fatal.
But too few patients participate in such trials even though studies show that routine care costs in cancer clinical trials are no more than in standard care, cancer experts have said.
