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Review highlights ‘imbalances, distinctions’ within oncology trials
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The manner in which oncology trials are conducted differs significantly from trials conducted in other specialties, according to study results.
The findings suggest the strengths and weaknesses of cancer-related clinical trials must be further assessed, the researchers wrote.
“This study provides an important snapshot summary of our current portfolio of clinical trials in oncology, highlighting imbalances and distinctions compared with other areas of health care,” Amy P. Abernethy, MD, of the department of medicine and oncology at Duke University Medical Center, told HemOnc Today. “This isn’t a statement of good or bad, but a place from which to start the discussion of the optimal distribution of trials needed to advance the state of science, evidence development and personalization in cancer care.”
Amy P. Abernethy
Abernathy and colleagues used identified interventional clinical studies registered on the website ClinicalTrials.gov between October 2007 and September 2010. The researchers validated the classification, subcategorized them by cancer type and stratified by design characteristics to allow for comparisons across cancer types and between specialties.
The investigators identified 40,970 interventional studies, of which 8,942 (21.8%) focused on oncology.
Oncology trials were more likely than those in other specialties to be open-label (87.8% vs. 47.3%; P<.001), nonrandomized (63.9% vs. 22.7%; P<.001) and single-arm trials (62.3% vs. 23.8%; P<.001).
Oncology trials were more likely to be smaller, with a median accrual of 51 patients vs. 72 patients in other specialties (P<.001). They also were more likely to be early phase studies — 83% of cancer trials were phase 1 or 2, compared with 51.6% of trials in other specialties (P<.001).
The researchers also observed disparities between cancer incidence and mortality of certain cancer types, as well as the volume of clinical research being conducted related to each type.
Lung cancer had the highest incidence, accounting for 14.5% of all new diagnoses and 27.6% of all cancer deaths in 2010; however, lung cancer was the focus of only 9.2% of trials. Bladder cancer accounted for 4.6% of all new diagnoses and 2.6% of cancer-related deaths but was the subject of 1.1% of trials.
The representation of breast cancer in clinical trials was proportionate to disease incidence, while trial representation of lymphoma (6.6%) was higher than its percentage of cancer incidence (4.8%) or mortality (3.8%), the researchers wrote.
“At the very least, this work should push us to ask whether we are adequately investing in areas with high mortality but lower numbers of trials (lung cancer), and whether we should demand that our evidence base in oncology continues to mature with more randomized adequately powered studies,” Abernethy said. “For the first time, we are able to see our clinical research investment as a community at the meta-view. In addition to guiding investment, this database will lead to better assessment and optimization of the details of conducting trials, such as timely accrual and alignment of outcomes.”
The researchers determined that only 15% of oncology trials are supported by NCI or other branches of the NIH, Peter B. Bach, MD, MAPP, of the department of epidemiology and biostatistics at Memorial Sloan-Kettering Cancer Center, noted in an accompanying editorial.
“In the setting of shrinking federal support of research (the sequester alone cut NIH funding by 5% this year), it is reasonable to predict that this proportion will fall,” Bach wrote. “Government-funded research is increasingly squeezed between the pincers of inadequate reimbursement for physicians enrolling patients in clinical trials and the rising work burden to those physicians per enrolled patient. The analysis is necessarily a flyover, a view from high altitude, and thus may gloss over some important dimensions of the research enterprise, but I am optimistic that the database will yield important insights as it continues to be augmented.”
Bach PB. JAMA Intern Med. 2013;doi:10.1001/jamainternmed.2013.6596.
Hirsch BR. JAMA Intern Med. 2013;doi:10.1001/jamainternmed.2013.627.
Amy P. Abernethy, MD, can be reached at amy.abernethy@duke.edu.
Disclosure: Abernethy reports no relevant financial disclosures.