No GCP violations by third party in Lyme disease trial, FDA finds

Research company Care Access has announced the completion of a for-cause US Food and Drug Administration (FDA) Good Clinical Practices (GCP) inspection related to Care Access’s activities on the Pfizer (NYSE: PFE) VALOR trial.

Pfizer blamed February’s decision to discontinue a significant percentage of US participants who had been enrolled in the Phase III VALOR study of VLA15, on “violations of good practice at certain clinical trial sites run by a third party.”

"This confirms what we’ve known all along about Care Access’ outstanding systems and controls"In total, more than 3,000 patients were discontinued despite Care Access disagreeing with Pfizer’s decision and rejecting the allegations. This figure represented around half of the total recruited participants in the trial.