Emory halts enrollment in cancer clinical trials

"We were surprised and chagrined by the extent of the problem," said Dr. Edmund Waller, the center's medical director. "We need to do better."

The sobering findings come at a time of heady success at the institute. Winship has grown rapidly in the past five years and was recently named Georgia's first National Cancer Institute center. That coveted designation is expected to draw millions of dollars in funding and top doctors to the center, as well as provide metro Atlantans with local access to cutting-edge care.

The NCI designation also opens doors to an exclusive tier of government and private research funds. It also could mean tens of millions of dollars for Georgia's economy as top biomedical firms, research companies and physicians come to work with the center.

Experts say there is little chance that the audit problems will affect the center's national designation. But the negative publicity could hurt the institute's reputation in the public's eye, said Dr. Richard Schilsky, a professor of medicine at the University of Chicago and chairman of a national clinical trials group.

He did not think the problems would prevent top physicians from coming to the center.

Dr. Otis Brawley, chief medical officer for the American Cancer Society, said it is not uncommon for audits of such clinics to uncover record-keeping problems in research files. He stressed that these records are separate from the patient's medical records, which are the primary source that doctors use in crafting care.

Waller, the center's medical director, said patient medical records were in good shape, and that the oncology group did not complain about the level of care given to the patients.

The Eastern Cooperative Oncology Group did not respond to requests for comment.

One relative of a Winship trial patient said that on one occasion the patient's CAT scan was not in the file being looked at by the doctor.

The relative, who did not want to identify the family for fear it would affect the patient's care, said the audit raised concerns about patient care and the management of the center.

The relative worried that information missing from the research file might also be missing from the medical file, which could hamper people's care. The relative also said the family complained several times about scheduling problems, and the issue was never addressed.

Since the audit, Waller said a more thorough review of records revealed that the problems with research records were not widespread at the center, and that they did not lead to problems with patient care.

Waller said the potential exists that a doctor could give an incorrect dose of chemotherapy medicine if the doctor was looking at incomplete research records.

The cancer institute has retrained staff and faculty on the proper ways to record research data on patients. A few staff members have been disciplined in connection with the problems, Waller said.

Missing or incorrect research information has the potential to skew the results on this research, but Schilsky said the chances are slim, since the results are often based on hundreds or thousands of patients from numerous centers.

Winship officials have continued existing trials on patients, and Waller said he expects to start opening trials to new patients this week.

Waller said that, in this instance, the center may be a victim of its own success.

"We grew so rapidly, maybe we got ahead of ourselves (in regards to this) data quality and data entry," he said.

At any one time, the center performs up to 120 clinical trials, handling about 1,000 patients. The center enrolls about 500 new patients each year.

"We take this matter very seriously to ensure we provide the best and safest care to our patients," Waller said. "We will fix these problems."