Two U.S. cancer centers are under scrutiny after routine inspections turned up potentially serious problems in record-keeping in clinical trials. Both centers—Emory Winship Cancer Institute in Atlanta and the Carle Cancer Center in Urbana, Illinois—have stopped enrolling new patients into clinical trials, although trials that are already up and running can continue with volunteers who signed on earlier.
According to the Atlanta Journal-Constitution, a routine audit by the Eastern Cooperative Oncology Group (ECOG), which helps coordinate multi-center clinical trials, found that Emory’s cancer institute wasn’t keeping proper track of research records. ECOG referred calls to the National Cancer Institute, which said it cannot comment on ongoing investigations.
Edmund Waller, medical director for clinical trials at the Winship, said, “this has been something of a painful and even somewhat embarassing pause in our progress, but we think we’ll be better for it in the end.” Problems included not keeping accurate logs of when its study volunteers were taking medication, or not keeping written records of information such as the outcome of an HIV test. About 100 adult trials have been affected by the accrual pause, says Waller; no problems were found with pediatric cancer trials, so those have been allowed to keep running. Meanwhile, the cancer institute has retrained all staff and physicians, and some trials in radiation oncology are enrolling new patients again. The halt in accrual was voluntary on Emory’s part, says Waller.
Problems at the Carle Cancer Center reportedly include failing to notify an ethics oversight board when changes were made to a trial and failing to notify federal officials of problems with trials, such as risks to subjects.