Fatal French Clinical Trail Failed to Check Data Before Raising Drug Dose

December 22, 2016

(Nature) – Criticism of the drug company at the centre of a disastrous clinical trial that left one participant dead and four with long-term neurological symptoms has intensified following a revelation that the firm did not use certain data when deciding to administer a higher dose that proved deadly. On 15 December, during a conference presentation by a scientist from the Portuguese company, Bial, it emerged that the firm did not use certain readings, called pharmacodynamic (PD) data, on how the drug BIA 10-2474 was acting in participants who had received a lower dose, before taking the decision to increase the dosage.