Chugai Pharmaceutical issues clinical trial apology

Chugai Pharmaceutical has apologised to patients after acknowledging that regulations on the provision of safety information were not followed during some of its recent clinical trials in Japan.

The company said the problem affected four of the 114 sites involved in the phase III trials of sustained erythropoietin receptor activator R744 and relevant information was not passed on to 15 of the 1,288 participating patients.

It said a Chugai employee, who is no longer with the company, had failed to give out the information and had also apparently illegally fabricated documentation related to the trials.

Upon discovering the regulations breach, Chugai said it immediately informed investigators, who duly issued the relevant safety information to the patients involved and checked their safety. None of the patients had experienced any ill health as a result of the breach, the company said.

Chugai then discontinued the study at the site affected and has issued an apology to both the patients and medical staff involved.

R744 is being trialled for patients with hemo-dialysis, peritoneal dialysis and renal failure in the pre-dialytic stage.

Chugai is a prescription drug manufacturer for the global market. It is based in Japan.