University Times

Now that the top leadership of the Pitt-based National Surgical Adjuvant Breast and Bowel Project (NSABP) is set, the cancer research group's principal investigators say it can move forward with clinical trials.

Under an administrative reorganization announced Jan. 27, Norman Wolmark of Allegheny General Hospital will be principal investigator of NSABP's operations office. Pitt's Ronald Herberman will remain principal investigator of the biostatistics center.

While the NSABP chairperson's office is located at Allegheny General, the operations office and the biostatistical center remain at Pitt, which retains ultimate oversight for project activities — at least for the time being. Officials at the National Cancer Institute (NCI) have said they will re-open NSABP's grants to competition later this year.

"Drs. Herberman and Wolmark are both brilliant and compassionate clinical researchers," NCI director Samuel Broder said in a release announcing the agreement. "They meet the exceedingly high standards of administrative excellence needed for the modern NSABP. Their leadership of NSABP will help bring the nation closer to prevention and cures of breast cancer and the other forms of cancer and related diseases." Herberman called the agreement "an important milestone in the revitalization of the NSABP so that it can optimally continue its very important research to improve the treatment and prevention of breast and bowel cancers." Wolmark said, "Everyone involved is pleased with a resolution that will enable us to move forward with the important work of clinical trials for the therapy and prevention of cancer." The agreement does not mention Bernard Fisher, who co-founded NSABP and led it for more than 30 years before being forced to resign in March. But according to Herberman, Fisher has been offered the job of scientific director, an offer contingent upon settling Fisher's lawsuit against the University.

Fisher sued Pitt in U.S. District Court last August, seeking reinstatement as NSABP chairperson and challenging the University's authority to remove him from the job. NCI officials insisted that Pitt remove Fisher as chairperson following reports of falsified data in NSABP studies at a Montreal hospital.

Fisher was unavailable for comment this week.

Herberman has been interim NSABP chairperson since Fisher's resignation. He is director of the Pittsburgh Cancer Institute and Hillman Professor of Oncology at Pitt.

Wolmark, a former Pitt professor, is director of the division of surgical oncology and director of the Allegheny Cancer Center at Allegheny General Hospital. Wolmark was nominated in November by the NSABP executive committee to be the group's new chairperson.

Duties of the NSABP operations office include developing and coordinating clinical protocols. This involves processing protocols through appropriate agencies such as NCI and the U.S. Food and Drug Administration and training personnel at participating research sites. The operations office will direct the science of the group; set research priorities; oversee group compliance with regulatory requirements concerning the use of investigative agents, the reporting of adverse events and the protection of human research subjects; oversee activities of principal investigators at NSABP sites; develop a budget and manage funding for participant accrual and follow-up; coordinate special studies and the collection of samples; convene and oversee meetings of the NSABP executive committee and other specialized committees, and write scientific reports. As chairperson, Wolmark will establish scientific and research priorities and appoint members of the NSABP executive committee.

The biostatistics center will collect and manage NSABP data; establish and conduct quality assurance and study monitoring procedures; be responsible for all aspects of the on-site audit program, including notification of Wolmark and the NCI about serious data irregularities; implement registration, randomization and analytic procedures for NSABP studies; and perform various statistical analyses of the results of clinical treatment and prevention studies for periodic review and inclusion in published scientific reports.

— Bruce Steele