Redundant and antiquated procedures, inefficient data reporting, staffing shortages, and declining clinical trial participation have created a clinical research crisis that's slowing clinical research and drug approvals, experts say. But they offer possible solutions to these problems.
A litany of problems—including antiquated data entry procedures, personnel shortages, redundant processes, and difficulties enrolling patients for trials—are hobbling clinical research and slowing drug approval, according to the speakers at a summit convened by the Society for Immunotherapy of Cancer on August 17. The Crisis in Clinical Research Virtual Summit involved more than 30 participants from academia, industry, the FDA, and the NCI who spelled out dozens of obstacles facing researchers—as well as a few potential solutions.
A sure sign that clinical research is in trouble, said David Hong, MD, of The University of Texas MD Anderson Cancer Center in Houston, is that despite efforts to accelerate testing and regulatory decisions, “we still take about 7.6 years to get a drug approved.”
COVID-19 deserves some of the blame for the state of clinical research, the attendees agreed, noting that accrual for trials has dropped globally since the start of the pandemic in 2020. But obstacles to clinical research aren't new. “COVID did not cause this problem. This is something that has been brewing for a long time,” said David Feltquate, MD, PhD, chief medical officer at Palleon Pharmaceuticals in Waltham, MA.
Data collection and entry remain bottlenecks. Even in the era of big data, clinical research sites still often enter data by hand, noted Stephanie Terzulli, PhD, vice president of clinical research operations at Memorial Sloan Kettering Cancer Center in New York, NY. The process is labor-intensive, inefficient, and error-prone, and it can slow research due to repeated back-and-forth conversations with clinical trial sponsors attempting to confirm details.
Lack of standardization about what data need to be reported—and even what reporting software to use—contributes to the problem. Because clinical trial sponsors don't have standardized forms or systems, trial sites often have to enter the same information over and over again, said Heidi Finnes, PharmD, senior manager of pharmacy cancer research at the Mayo Clinic Comprehensive Cancer Center in Rochester, MN.
Staff shortages growing, trial accrual lagging
Data difficulties dovetail with another research-thwarting challenge: a shortage of qualified personnel. Like other sectors of the economy, research sites are struggling to retain workers, noted Krystyna Kowalczyk, president and CEO of OncoBay Clinical, a clinical research organization (CRO) in Tampa, FL. “Enrollment ebbs and flows,” she said, but the staffing shortage “is a new problem.”
Employee scarcity is acute for academic centers, which cannot pay as much as biotech firms or CROs, according to Hong. He said his group has lost six research coordinators in a little over 2 years and has delayed some trials. “We don't have the pool of people and quality of people we need to run these trials.”
Although the pandemic slashed clinical trial participation, it prompted ideas about how to increase accrual. Marc Theoret, MD, deputy director of the Oncology Center of Excellence at the FDA, noted that the agency issued new guidelines to ensure that clinical trials could proceed safely when the COVID-19 pandemic began. Among the recommendations: allowing patients to provide informed consent electronically, permitting virtual patient assessments, and permitting home administration of some treatments. These strategies could help draw in patients who have busy schedules or cannot travel to trial sites.
In addition, sponsors and organizers are still struggling to increase trial participation by underrepresented groups. Few clinical trials include the community sites where 85% of cancer patients are treated, Kowalczyk said. “We are missing an entire population.”
Speakers pointed out several practical obstacles that could make it difficult to enlist these sites. If only a few patients will be involved in a trial, a site may decide the costs are too high. Some complex treatments, such as chimeric antigen receptor T-cell therapy, can't be administered at these sites. And doctors at these facilities often already have full schedules, and their job performance is rated by the number of patients they see, not how many patients they enroll in clinical trials. “I don't think it's so easy to bring trials to the community,” said Mario Sznol, MD, of the Yale Cancer Center in New Haven, CT.
Not surprisingly, experts agreed that excessive red tape is holding up research. As several speakers noted, first-in-human phase I trials are often performed in Australia, which offers a streamlined process for getting the go-ahead to start a trial. One bureaucratic barrier that needs reform is the scientific review committee (SRC), which vets the design and research value of a trial before the institutional review board (IRB) pronounces on safety.
“The SRC is typically the big holdup,” said Charles Theuer, MD, PhD, CEO and president of TRACON Pharmaceuticals in San Diego, CA. Multisite trials often rely on a single IRB, simplifying trial approval. Perhaps centralized SRCs could be implemented as well, participants suggested.
Tackling these problems will be difficult, acknowledged Leisha Emens, MD, PhD, of the University of Pittsburgh Medical Center Hillman Cancer Center in Pennsylvania. “We are trying to change culture and infrastructure.” The summit did not provide a comprehensive plan—participants vowed to issue a white paper in the future. But the speakers agreed on several measures that could make a difference. For example, to ease staffing shortages, research sites should focus on improving opportunities for employees, such as defined career paths, training, and education.
Another helpful measure would be for organizations like the NCI to set data reporting standards, said Jason Luke, MD, also of the Hillman Cancer Center. “That's an easy first step that ought to be possible.” –Mitch Leslie
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