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Pharmaceutical industry support has far surpassed federal funding for clinical research in the United States. And many drugs currently under development are designed by the industry to fight cancer. So researchers at the University of North Carolina School of Medicine and Dana-Farber Cancer Institute undertook a small project to see if there was any association between pharmaceutical company involvement and outcomes in breast cancer clinical trials. It was the only study of its kind conducted in breast cancer re search and only the second on any type of cancer. Published in April in Cancer , the paper looked at 140 studies conducted in 1993, 1998, and 2003 — arbitrarily chosen 5-year spans — and found no statistically signifi cant difference between positive outcomes and industry versus nonindustry authorship (78% versus 66%). But when they focused on the 56 studies published in 2003, when disclosure requirements were the tightest, they found that 84% of studies reporting pharmaceutical involvement were positive, compared with 54% of studies not associated with the industry. Industry-associated research was also more likely to be single armed (66% versus 33%) and to evaluate metastatic disease (72% versus 46%). This is just the most recent fi nding in the debate over industry-sponsored trials. Supporters say companies just spend more to design good trials. But detractors say industry studies are shrouded in secrecy and may be biased. Meanwhile, researchers hope that comprehensive clinical trial registries, such a new one set up by the World Health Organization, may help eliminate some of the problems. Similar studies in other disciplines, such as cardiology and psychiatry, have found the same associations between sponsorship and positive outcomes. But the authors of this breast cancer study weren’t willing to jump to specifi c conclusions because their study was so limited — it just looked at published reports without the benefi t of viewing any other data. “Though it was a relatively small sample, we found a significant association between industry in volvement and positive outcomes, which I think is a starting point rather than an ending point for further investigation,” said Jeffrey Peppercorn, M.D., assistant professor of medicine in UNC’s School of Medicine’s division of hematology and oncology. Peppercorn and the other three authors say they don’t know how to explain the positive outcomes in industry-associated trials. “Possibilities to explain this could be that industry is making smarter, or perhaps safer, choices in their trial design, or that there is bias either in the study design or the reporting of results or burying of negative results, which is absolutely possible here,” Peppercorn said. “It’s like if a baseball player is hitting more home runs than other baseball players. It could be because he’s on steroids. But it could also be that he’s a better player,” he said. The pharmaceutical industry said their good results come from old-fashioned practice that hones their trial design skills. “Companies invest a lot of time and money in their clinical research, and they spend a lot of time thinking about what to study,” said Caroline Loew, Ph.D., senior vice president of science and regulatory affairs at the industry trade group, Pharmaceutical Research and Manufacturers of America (PhRMA). These studies are conducted with extreme rigor given the highly regulatory environment in which they are reviewed for approval and the intense scrutiny they receive, she said. Peppercorn wasn’t surprised by what he found, but the worldwide level of interest in the study took him aback. Newspaper articles appeared in many nations, and scientifi c interest was also high, he said. “I think people are hungry for an understanding of what the impact of pharmaceutical involvement is on trials and patients.”

Small Study on Industry Trial Sponsorship Leads to Big Questions About Quality and Bias