UCSD’s Moores Cancer Center retools clinical trials office as director steps down for ‘personal’ reasons

The Moores Cancer Center at UC San Diego Health is retooling its clinical trials office just as its director is stepping down for “personal” reasons after about a half-year at the helm.

The two are unrelated, according to UCSD officials.

UCSD also emphatically denied a report by The Cancer Letter, an independent weekly news publication that covers oncology, that claims Moores is on the precipice of losing its National Cancer Institute designation as a comprehensive cancer center, the only such designated center in the region.

“No one is in danger of losing comprehensive [designation],” Dr. John Carethers, UCSD’s vice chancellor for health sciences, said June 7.

The Cancer Letter’s editor and publisher, Paul Goldberg, said the publication “stands by the story.”

Moores spokeswoman Jacqueline Carr said in a statement that the center “is in a leadership transition while simultaneously redesigning its clinical trials operations.”

Moores Director Dr. Joseph Califano III made his “own personal decision” to step down, Carethers said.

Califano, a La Jolla resident, is expected to stay in the post until a replacement can be found. Last year he succeeded Dr. Scott Lippman, who had been director since 2012.

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Califano said in an email that he is stepping down “so I can devote my time and efforts to care of patients with head and neck cancer, directing a laboratory focused on head and neck cancer research.”

Carethers said Califano will remain director of Moores’ Hanna and Mark Gleiberman Head and Neck Cancer Center and co-leader of the Structural and Functional Genomics Program. He also will retain his role as a UCSD professor and member of the Moores Cancer Center, Carethers said.

UCSD soon will name an advisory committee to conduct a nationwide search for a new Moores director.

UC San Diego Vice Chancellor of Health Sciences John Carethers says Moores Cancer Center’s redirection is unrelated to its director stepping down.

(UC San Diego Health)

Meanwhile, the cancer center is redesigning its clinical trials office to increase the number of trials offered, which declined during the COVID-19 pandemic, Carethers said.

“As the region’s only NCI-designated comprehensive cancer center, clinical trials are a central part of the Moores Cancer Center mission of advancing the science of potential cancer therapies,” Carr said.

The number of clinical trials is still down from pre-pandemic levels, Carethers said, a function of a slower rebound in San Diego due to higher costs of living and labor, which leads to challenges in getting adequate staffing.

“Our goal is to get those trials back up,” he said. “We need to get our act together because clinical trials are an important part of not only our regions but it’s also an important part of how the NCI recognizes us as a comprehensive cancer center.”

However, Carethers reiterated that there is no current risk of Moores losing its designation.

The National Cancer Institute did not respond to a request for comment.

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Still, citing Califano’s decision to leave the director job and the recent departures of some other key leaders, The Cancer Letter story makes the case — quoting unidentified sources and leaked documents — that Moores’ entire portfolio of more than 200 clinical trials should be suspended and that “they are risking patient safety by not doing so.”

“There’s always change” in institutions like Moores, Carethers said, whether in leadership or the direction of various departments.

“As part of deliberate performance improvement initiatives, and in preparation for core grant renewal, Moores Cancer Center proactively requested that Kelly Willenberg & Associates conduct a virtual review of its clinical trial processes,” Carr said.

The review was at Califano’s direction, Carethers said.

“He asked some consultants to look at the clinical trials and that’s exactly what they did,” Carethers said. The work was “something … most campuses do if they’re always continuing to look for improvement” every few years, he added.

The university objected most strongly to any suggestion of possible patient harm.

The draft report on the review “cites zero incidents of harm to any clinical trial participant,” Carr said.

All human research programs in the United States are required to have institutional review boards, or IRBs, to make sure patients’ rights are protected and to collect reports of “adverse events” for investigation if something goes wrong while trials are underway.

Carethers said he examined two years of adverse event reports made to UCSD’s IRB by cancer trials and found no spike in overall numbers.

“The number of events you can essentially count on one hand, and most of these things are not serious — someone didn’t document something on time, that sort of thing,” Carethers said. “And has there been corrective action from the [institutional review board] when these events are reported? Absolutely there has.”

Audits of the clinical trials office by the university’s compliance office and the U.S. Food and Drug Administration have identified no problems with adverse event reporting in the program, he said.

Comprehensive cancer centers such as Moores also are required to maintain external advisory boards made up of cancer experts not affiliated with the university.

The Cancer Letter report indicates that Moores’ advisory board has weighed in, stating that the program’s clinical trials organization, “in addition to having no permanent leader, is starved for resources and is in such profound disarray that ... it poses a danger to patients.”

But Dr. Eric Small, a cancer researcher at UC San Francisco and a member of the Moores advisory board, said in an email that the full panel responded to the write-up with a letter signed by all members indicating that “we are not aware of any incident at [Moores Cancer Center] in which patient safety was affected and that UCSD and MCC leadership have our full vote of confidence.”

With more than $73 million in annual research grants, some 400 members, 13 disease teams, five research programs and national experts in cancer care, “Moores Cancer Center not only is an asset to the university, it’s an asset to our community,” Carethers said. “We’re going to do our darndest to make sure that continues and meets the high excellence standard so that patients can get the appropriate care for all their cancer needs here.” ◆