Spanish investigator conducted clinical trial without regulatory or ethics approval

Science magazine reports that a well-known Spanish HIV investigator has lost an appeal against a verdict that he conducted a clinical trial without regulatory or ethics approval.

Vicente Soriano registered a Phase IV study on ClinicalTrials.Gov in July 2009 and published a paper in the journal HIV Clinical Trials in 2010. However, the study had not been approved by the Spanish Agency for Medicines and Health Products, had not received ethics approval from the Hospital Carlos III where the study was conducted, and did not have adequate insurance.

Soriano had argued that the study had been retrospective and observational, and that the change in treatment (involving the replacement of a protease inhibitor by a novel integrase inhibitor in patients’ combination therapy) was within the scope of what a doctor might recommend. However, the Madrid Superior Court of Justice rejected his appeal by a majority verdict, and Dr Soriano is facing a fine of €210,000.

The study followed 222 patients over 24 weeks and concluded that “a switch from PIs to raltegravir in HIV-infected patients with undetectable plasma HIV-RNA effectively sustains viral suppression”.