Only 11 percent of 262 scientific articles had all of the information clinicians say is needed to prescribe and monitor new cancer therapies for their patients, according to University of Florida researchers. The findings were first published May 19 in the Journal of the National Cancer Institute.
“This study came out of our clinical frustration,” said Dr. Thomas George Jr., a member of the UF Shands Cancer Center and director of UF’s Gastrointestinal Oncology Program in the College of Medicine. “We were trying to teach our students and fellows how to care for patients with cancer and prescribe therapeutics safely. We had a really hard time finding the information we needed to provide care for these patients in the original scientific articles.”
George says that his team’s recommendations — especially one that journal editors and publishers revamp the way they edit and report on clinical trials — represent a “paradigm shift” that is not likely to be embraced right away.
“It just boils down to willpower on the part of journal editors to agree that this is an important need,” he said. “I think the scientific community — the publishers, the editors and even the investigators who conduct the studies — have been appropriately focused on justifying the scientific methods and merit of the study. We’re just taking it to the next logical step, which is, how do we apply these results to the masses of patients who need to benefit from scientific progress?”
Investigators asked a separate, multidisciplinary group of cancer clinicians to identify the minimum information necessary to use a scientific report to guide clinical care. The list included such clinically important items as the name of the drug and how it was administered.
The team then analyzed 262 reports published from 2005 to 2008 in the Journal of Clinical Oncology, The New England Journal of Medicine, the Journal of the National Cancer Institute, and the journals Cancer and Blood.
Overall, the journals presented 73 percent of this minimum information required, ranging from 71 percent in Cancer to 80 percent in the Journal of the National Cancer Institute. The Journal of Clinical Oncology, which published 63 percent of the studies analyzed, carried 73 percent of the information needed.
While the dose of the drug was almost always reported, only 43 percent of the papers reported what kind of premedication was necessary, and only 42 percent reported how to adjust dosages if the therapy proved toxic. Only 11 percent of the papers were complete in their inclusion of all minimum information required.
“I am not surprised at the lack of adequate clinical information for prescribing the proper dose for therapeutic drugs and detecting the treatment effects of interventions in cancer care,” said Thomas T.H. Wan, a professor of public affairs, health management and informatics, and medicine at the University of Central Florida in Orlando. The problem might stem from a lack of consistency in defining and measuring cancer outcomes, and as well as inconsistency in how cancer care is documented, Wan said.
“Comparative effectiveness analysis is the key to solve the above issues,” said Wan, who was not involved in the study. “It would take a concerted effort of collaborative research and analysis conducted by clinical scientists, health services researchers, decision analysts, clinical epidemiologists and social scientists.”
The UF researchers called on the scientific community to develop detailed guidelines that ensure clinical trial reports can be used in a clinical setting, comparable to existing guidelines that ensure the scientific accuracy and merit of such reports.
Such measures would be in line with goals set by the National Institutes of Health to speed therapies to the public.
“The NIH has sponsored a nationwide initiative to improve human health by making new clinical therapies available more quickly,” said Dr. David Nelson, director of the UF Clinical and Translational Science Institute. “The NIH has established a consortium of academic institutions whose mission is to accelerate the translation of research into clinical practice, and the UF CTSI is part of this nationwide initiative.”
Study team members included George and fellow investigator Dr. Jennifer M. Duff, of UF’s division of hematology and oncology. Other study investigators were Helen Leather and Edmund O. Walden, from the UF department of pharmacy, and Kourtney D. LaPlant, of the North Florida/South Georgia Veterans Health System.
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