Cancer Center Stumbled on Clinical Trials, Ex-Employee Charges

Staff Writer

Molecular biologist Suzanne Stratton was working to improve clinical trials at the Carle Cancer Center of Urbana, Illinois, when she was fired late last year—prompting an investigation of the center’s standards, according to a report in The New York Times.

Stratton argues that her dismissal raises questions about the quality and safety of studies at this and other community medical centers funded by the National Cancer Institute.

Stratton told the Times that she was hired several years ago to help oversee the Carle Center’s expanding program of clinical studies, partly funded by NCI in a new push to bring cutting-edge medicine to a wider community. After a disagreement with bosses, Stratton was dismissed in 2008; she then informed NCI about problems she had seen, including an allegation that physicians were exaggerating the benefits of trials and not obtaining proper consent from patients.

NCI is investigating, but officials at the agency were not immediately available to discuss findings. The spokesperson for the Carle Center did not respond to telephone and email messages from ScienceInsider requesting comment. [see update below]

In a statement issued late today, Carle Clinic took issue with Stratton's allegations but declined to discuss them because they involve "a personnel issue." The statement continued: "Many of the concerns raised in the [New York Times] have been found to be unsubstantiated or adequately addressed by an audit of the U.S. Department of Health and Human Services Office of Human Research Protections (OHRP). For the remaining issues, we have been diligently working to address them."

Here's the full text of the statement:

Carle Clinic is aware of an article in the October 23 issue of The New York Times regarding the research program at Carle Cancer Center.

Suzanne Stratton is a former employee of Carle Foundation Hospital who provided information for the story. We don't agree with many of statements attributed to her, but cannot discuss her allegations further, as this is a Carle Foundation Hospital personnel issue.

Many of the concerns raised in article have been found to be unsubstantiated or adequately addressed by an audit of the U.S. Department of Health and Human Services Office of Human Research Protections (OHRP). For the remaining issues, we have been diligently working to address them.

It is important to note that many of OHRP's concerns are with administrative issues such as lack of clear policies and procedures. OHRP's determination letter did not indicate in any way that patients suffered harm as a result of participation in clinical trials. Further, OHRP's determination did not indicate that the integrity of any research was compromised by the issues identified, and in particular, did not find any failures to obtain patient's informed consent as was alleged by Ms. Stratton.

It is significant that OHRP has taken note of our commitment to patient safety as illustrated in its last letter to Carle Clinic: "In the course of the OHRP on-site evaluation, the IRB members, IRB staff, and investigators displayed an enthusiastic and sincere concern for the protection of human subjects."

The National Cancer Institute and National Institutes of Health have taken issue with The New York Times article and asked the publication to issue a correction. That formal written request can be read here.

We will continue to respond to any additional requests OHRP may pose and appreciate the review and opportunity to improve upon research at Carle Clinic. Carle Clinic has been active in clinical research for over 25 years, during which time many patients' lives have been improved by the advancements, directly or indirectly, made as a result of that research. Research is a significant part of advancing cancer care and we remain committed to high quality clinical research and patient care.

Jennifer Hendricks Kaufmann
Manager, Public Relations & Communications
Carle Clinic

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