Shortcomings in heart failure drug trial open “can of worms”BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2218 (Published 08 May 2017) Cite this as: BMJ 2017;357:j2218
- Nigel Hawkes
An international trial of a treatment for heart failure conducted by a contract research organisation (CRO) was compromised by the failure of many participants to receive the drug being tested, the trial’s investigators have found.
Blood tests taken from a sample of patients in Russia and stored since the trial ended showed that 30% of them had no sign of an active metabolite of the drug spironolactone which would have been present if they had taken it. Among patients in Argentina, Brazil, Canada, and the US only 3% showed no evidence of the metabolite.
In the New England Journal of Medicine, Marc Pfeffer, of Brigham and Women’s Hospital in Boston, and colleagues said that the evidence raised questions about how the trial was conducted in Russia and, by implication, in Georgia.1 Half the trial participants came from these two countries and a …