Two years after facing criticism that its clinical trials office was in “profound disarray,” UC San Diego Moores Cancer Center is pursuing renewal of a key federal grant with confidence, its new leader pointing to significant gains in local oncology research that she says show the university’s comprehensive cancer program is thriving.
Dr. Diane Simeone, a well-known pancreatic cancer researcher and Moores’ executive director, worked last week to put the finishing touches on the nearly 2,000-page application filed Friday. The paperwork seeks to add another five years to its cancer center grant from the National Cancer Institute.
This critical federal funding source not only brings in about $5 million per year in operating revenue, according to government spending records, but it also is required for Moores to remain one of 57 comprehensive cancer centers nationwide, one able to prove that it not only treats cancer patients effectively, but is also engaged in cutting-edge research.
Hired away from Perlmutter Cancer Center in New York, Simeone has been on the job a little more than one year, but says she has no difficulty making a case for renewal of its grant.
“I think our data is amazing,” she said. “We’ve seen our NCI funding increase 50 percent over the past five years, our clinical trial numbers are increasing rapidly, and we’ve made a big investment in reaching out to the community by working with federally qualified health centers.
“This is a very positive place and an exciting place to be working.”
It is exactly the type of confidence that seemed like it would be difficult to sustain in 2023 after a trade publication called The Cancer Letter published a scathing critique of Moores’ clinical trial operations.
Quoting anonymous sources and citing a consultant’s “virtual review” of Moores’ internal operations, the piece warned that dysfunction, which included the departure of several top leaders, could put patient safety at risk and indicated that there was internal pressure to suspend enrollment in cancer trials until problems could be resolved.
A headline delivered an even more dire warning, stating that “UCSD’s comprehensive cancer center designation is in trouble.”
Simeone said that after getting up to speed, she came to her own conclusion about the criticisms leveled against the organization she now runs.
“All of those reviews were unfounded,” she said. “I came here because I knew the potential of this place, and I believe in the people we have here and what they can accomplish.”
But that is not to say there is total certainty as Moores seeks its grant renewal.
While Simeone said she is confident that the essential request would meet the commonly understood requirements for renewal, much has changed in Washington as the Trump istration cancels some existing research grants and renews others.
Though she has served on the National Cancer Institute committees that review cancer centers for grant renewals, it’s clear that the peer review process used in the past is no longer in place.
“The committee that has reviewed cancer centers in the past has now been cancelled,” Simeone said. “There are five or six centers with deadlines to submit their grants on May 25, and those applications are going to be reviewed centrally, but we don’t exactly know what that process is going to be like.”
Regardless, the executive said she is proud of the gains that Moores has made in both enrolling more patients in clinical trials and in offering more trials overall.
This year, Moores projects that it will enroll 699 patients in clinical trials, a 59% increase over the 438 patients it enrolled in 2024 and a 141% increase over the 290 patient participants in 2023.
Sixty new trials have been activated in 2025, and the total is expected to hit 167 by the end of the year, compared to 108 last year and 91 in 2023.
The time it takes to activate a new clinical trial is now 88 days compared to 126 last year, and 93% of studies “enrolled their first patient within three months of study activation.”
How did Moores manage to turbocharge its clinical trials performance so quickly? At a recent symposium for trial participants, Simeone pulled senior istrative director Joyce Tull and Dr. Rana McKay, leader of Moores’ multidisciplinary prostate cancer clinics, out of the lunch line at the event, highlighting their efforts that, with the help of others, reorganized the clinical trials office to run more efficiently.
Tull, who Simeone brought in from a previous clinical trial coordination effort at UC Davis, said that increasing trial participation required more “eyeball-to-eyeball” work with researchers.
“That work started long before I ever arrived here, and it has been a very concerted effort over the last year and a half that has made a substantial change,” Tull said. “We’re now driven by data and metrics and dashboards.
“It comes down to ing your investigators and saying, ‘what do you need, what do you want, how is this going to work?”
There was also, McKay said, a need for some basic reorganization among the specialists who coordinate Moores’ research efforts.
“We centralized a lot of processes because we were very disted,” McKay said. “You know, people were doing their own little mini clinical trial offices all across the different disease scenes, but we basically developed expertise in each one of the steps of the assembly line to get a study activated and basically to make it as efficiently broad as possible.”
Another criticism that was leveled at Moores back in 2023 had to do with the percentage of trials that were run by a local researcher as opposed to serving as a satellite enrollment location for a trial created somewhere else.
Here, Simeone said, there has been additional effort expended.
“We’ve tripled, just in the last year, our number of what we call investigator-initiated trials,” she said. “We’ve put in place a number of different activities to drive that, from training courses to identifying science that’s compelling and that should move along the trial pipeline.
“So that’s now becoming part of the DNA here, where I would say maybe it was not as emphasized as it could have been in the past.”
