Cancer Centers Under Pressure: Drug Development Boom Tests Capacity of Large Research Institutions

The boom in cancer drug development has left the nation's largest research institutions facing a flood of clinical trial applications, which some say has made the system bloated and inefficient.

"Most institutions are running far more trials than are actually needed," said John DiPersio, deputy director of the Alvin J. Siteman Cancer Center in St. Louis. He estimates the center currently has more than 500 open clinical trials.

Immuno-oncology—the study of how to harness the immune system to fight cancer—is a major driver. Over the past five years, the field has grown rapidly following the success of Merck's Keytruda and Bristol Myers Squibb's Opdivo, and it remains a key investment area for pharmaceutical companies.

Industry data provider Informa counts 2,731 immuno-oncology R&D projects in development this year, up 16% from 2018. For Keytruda alone, more than 1,000 trials are underway.

Many programs rely on large urban institutions to conduct research, such as MD Anderson Cancer Center in Houston, Memorial Sloan Kettering Cancer Center in New York, or Moffitt Cancer Center in Tampa, Florida. These institutions have extensive experience in executing clinical trials, as well as infrastructure such as nursing support and imaging equipment to meet patient and data collection needs.

At the same time, they see more patients than rural or community centers, which can help speed enrollment, especially in rare cancer research—Ferran Prat, head of industry relations at MD Anderson, estimates that about half of all osteosarcoma cases in the U.S. are seen at that center.

Pharmaceutical companies' oncology investments are a business boon for these institutions, but they also bring challenges. Prat noted that the increase in clinical trial applications has made MD Anderson more selective in choosing which studies to take on and which companies to partner with.

"Many companies still operate with the old mindset that if they ask, we will take on the trial," Prat told BioPharma Dive. "The reality is that we are increasingly saying no because we believe the scientific value is not high."

Doctors also face difficulties in filling enrollment for new trials. DiPersio estimates that about a quarter to a third of cancer clinical trials remain open for a year without any patients enrolled. He said empty trials not only create an "economic burden" on institutions due to the regulatory and logistical work required to launch them, but also reflect broader enrollment problems.

Industry and academia say only about 5% of cancer patients participate in clinical trials, but many believe the rate could be higher if enrollment criteria were less strict. Mildly abnormal lab results or a hepatitis infection decades ago can lead to a patient being denied enrollment.

"After all that effort, testing, time, and multiple visits, it's disappointing to be excluded for a minor deviation from the criteria," DiPersio said.

Pharmaceutical giants such as Merck and Pfizer say they want to improve trial accessibility and efficiency. Eric Rubin, vice president of global clinical oncology at Merck Research Laboratories, said one priority is providing more community trial sites when drugs move into larger, later-stage development.

"If patients can participate at a local site rather than driving to New York City, that could determine whether they enroll in a trial," Rubin told BioPharma Dive.

Pfizer currently has more than 125 cancer clinical trials running at nearly 3,200 sites worldwide. Chris Boshoff, Pfizer's chief development officer for oncology, said enrolling patients outside large research institutions is not a major issue, but he noted that cancer clinical trials overall "still have much room for improvement."

DiPersio believes one sticking point is the lack of communication between trial sites and sponsors after a protocol is approved. He suggests holding meetings before a site launches, which could lead to more streamlined, patient-friendly protocols.

"Can we reduce the burden on patients? Nobody asks that. For example, why do a bone marrow test every three months? Or do we really need three biopsies of this tumor?"

Anotherunresolved questionis whether certain immuno-oncology drugs deserve so much clinical attention. For example, the U.S. Food and Drug Administration has approved six drugs targeting the PD-1 immune pathway, including Keytruda and Opdivo, with more in development.

A large number of clinical trials are testing these drugs across different tumor types or in combination with other therapies. Although in areas such as kidney cancerresults are encouraging, some worry that other potential therapies may not receive enough attention.

"All companies are trying to prop up their stock prices because they must have an immunotherapy drug on the market," Joseph Unger, a biostatistician and health services researcher at Fred Hutchinson Cancer Research Center, told BioPharma Dive.

As a result, they "are collectively slowing down the development of these drugs by developing too many similar drugs in too many clinical trials."

However, crowding is not universal. Pfizer's Boshoff said he often hears about U.S. academic institutions conducting a large number of first-line lung cancer immunotherapy studies, but "that's a very specific situation right now." "Globally, the problem is not as severe," he said.

Nevertheless, the increase in trial numbers and competition puts pressure on doctors to produce meaningful results. In fact, one criterion pharmaceutical companies consider when selecting trial sites is whether the institution has a history of producing high-quality data quickly.

"Institutions face enormous pressure and costs to hire large numbers of clinical trial assistants, not only to ensure that enrolled patients receive the correct treatment, but also to ensure that data is entered into the database in a timely manner," DiPersio said.

At MD Anderson, funding is not the main issue. Prat said that as a state institution, it can only provide services at fair market value. The real limiting factors are time and resources.

"We have to increase our capacity to expand our volume," he said. "That's something we work on improving every day."