11种杂志计划采取有关报告公司资助的试验数据的政策
WASHINGTON (Reuters Health) - Clinical investigators will soon have more say about what data from corporate-sponsored clinical trials are published in some of the world's most prominent medical journals.
In September, eleven journals are planning to publish a joint new editorial policy, under which the journals have agreed to refuse to publish company-sponsored data unless the clinical investigators are guaranteed scientific independence.
Among the participating publications are Annals of Internal Medicine, The Lancet, The Journal of the American Medical Association, and The New England Journal of Medicine.
According to Dr. Jeffrey M. Drazen, editor-in-chief of The New England Journal of Medicine, the general idea was agreed to at a meeting in May as a means of ensuring that clinical investigators are allowed to participate in the design and analysis of clinical trials.
While there is no evidence of an industry-wide conspiracy to keep clinical investigators out of the process, there have been incidental cases demonstrating that clinical investigators could use additional scientific independence, Dr. Drazen explained in an interview with Reuters Health.
For example, he said, some companies have attempted to suppress the publication of unfavorable results or "spin" unfavorable data in a positive light by limiting the participation of their academic researchers.
"I think broadly defined it's an issue of academic freedom," Dr. Michael Whitcomb, senior vice president of medical education at the Association of American Medical Colleges, told Reuters Health. "But I think it also is an issue of integrity."
Industry representatives counter that the new policy could undermine the publication process. "We believe the editors have excessive concerns," Meredith Art, a spokesperson for the Pharmaceutical Manufacturers of America, told Reuters Health. "These companies value their scientific credibility."
Dr. Drazen maintains that the new editorial policy will simply ensure publication of relevant, high-quality information. "If a corporate trial makes a good valid point using acceptable data, it will be published," he said., 百拇医药
In September, eleven journals are planning to publish a joint new editorial policy, under which the journals have agreed to refuse to publish company-sponsored data unless the clinical investigators are guaranteed scientific independence.
Among the participating publications are Annals of Internal Medicine, The Lancet, The Journal of the American Medical Association, and The New England Journal of Medicine.
According to Dr. Jeffrey M. Drazen, editor-in-chief of The New England Journal of Medicine, the general idea was agreed to at a meeting in May as a means of ensuring that clinical investigators are allowed to participate in the design and analysis of clinical trials.
While there is no evidence of an industry-wide conspiracy to keep clinical investigators out of the process, there have been incidental cases demonstrating that clinical investigators could use additional scientific independence, Dr. Drazen explained in an interview with Reuters Health.
For example, he said, some companies have attempted to suppress the publication of unfavorable results or "spin" unfavorable data in a positive light by limiting the participation of their academic researchers.
"I think broadly defined it's an issue of academic freedom," Dr. Michael Whitcomb, senior vice president of medical education at the Association of American Medical Colleges, told Reuters Health. "But I think it also is an issue of integrity."
Industry representatives counter that the new policy could undermine the publication process. "We believe the editors have excessive concerns," Meredith Art, a spokesperson for the Pharmaceutical Manufacturers of America, told Reuters Health. "These companies value their scientific credibility."
Dr. Drazen maintains that the new editorial policy will simply ensure publication of relevant, high-quality information. "If a corporate trial makes a good valid point using acceptable data, it will be published," he said., 百拇医药