Fatal French clinical trial failed to check data before raising dose

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. When asked why the company had not included the PD data in its dose-escalation decision, Helena Gama, head of Bial’s pharmacovigilance and drug safety office said, “The evaluation before starting a new drug escalation is based on safety evaluation and pharmacokinetic data” — referring to other data on how the drug is absorbed, distributed, metabolized and excreted by the body. “We did not have any profile that precluded the path to the further dosage.”

To read more, click French clinical triail irregularities.