Carle Cancer Center Ordered to Stop Taking New Trial Patients
A Carle Clinic official says a federal decision barring the admittance of new patients for clinical trials at Carle Cancer Center shouldn't be cause for alarm.
The grants administration office at the National Cancer Institute issued the order, saying its Office for Human Research Protections, or OHARP, won't allow new patients to be enrolled while a series of patient protection issues have been resolved.
Carle Clinic Vice President for Planning and Marketing Carol Koenecke-Grant says many of the areas cited were administrative functions, and that these problems are not unique to Carle. She says OHARP is planning to conduct an audit next month to review filings and documentations:
"When one has something like that, you put policies and procedures in place to explain how you're going to store records, how you're going to document things, all of that," Koenecke-Grant said. " This is pretty typical for any organization that conducts clinical trials."
An letter from OHARP obtained by the News-Gazette listed 11 separate cancer clinical trials in which concerns have been raised, including protocol changes conducted by a Carle research investigator without obtaining the required approval.
Koenecke-Grant says a protocol change cited by federal order could be citing something as simple as a scheduling change. She says one example could be that a patient on a protocol fails to attend a lab test on a particular day.
But Koenecke-Grant says it's important to note that this ruling does not affect current Carle Cancer Center patients and that federal officials felt comfortable that it continue with those clinical trials. Carle is to respond to two pages of recommendations by July 7th.
A doctor with the National Cancer Institute, which handles clinical trial programs wasn't available for comment Thursday.