What Is patientINFORM?

Summary: Breast cancer studies supported by drug companies are more likely to report positive results than those without pharmaceutical industry backing, according to a new study. The findings raise concerns about the "the design, conduct and reporting of clinical trials," the researchers say in their report.

Why it's important: Breast cancer strikes more than 1 million women worldwide each year, and research and development of new drugs are critical to fighting the disease. The drug industry now spends more money on research and development than the US National Institutes of Health, according to the study authors. With that comes more collaboration between industry and academic medical centers, which in turn has raised questions about the quality of research and potential conflicts of interest. All study results, whether positive or negative, can give researchers important information about the course of a disease and its treatments. The study authors do not assert drug company sponsors are hiding study information; just that drug-company sponsorship is an area that needs further monitoring and research.

What's already known: Other studies have shown drug-company sponsorship yields more positive results in various categories, including heart, stroke, and bone marrow cancer research in comparison to studies without industry backing. Nobody has found the reason behind the link between drug company involvement and positive results. It is possible that negative results are just more likely to never be published, either because the study was never completed, or because its results were never submitted for publication, the study authors write. Industry-sponsored studies may also turn out more positively because the drug companies only pursue the most promising treatments. It's also possible that industry-backed studies are more likely designed to show a certain drug or therapy in a better light, the study authors say. This could be accomplished by ignoring the randomized, control design of rigorous, respected clinical trials. In a randomized, controlled study, people are randomly assigned to one of two groups: those who get an experimental treatment and those who get an established treatment. This study design is widely considered the best since you have two groups to monitor and compare in research. Future studies should look at whether industry sponsorship has an impact on study design, the authors say.

The American Medical Association and a group of leading medical journals are pushing for data on all drug trials to be made public (while still protecting patient privacy). They say that would give researchers more of the information they need about the risks and benefits of treatments.

How this study was done: A research team from the University of North Carolina, Chapel Hill, and the Dana-Farber Cancer Institute analyzed 140 studies dealing with breast cancer published in 1993, 1998, and 2003 in 10 medical journals.

What was found: They found nearly half of the studies performed during this time had drug company ties. Of breast cancer studies published in 2003, 84% with industry backing reported positive results compared with 54% of studies with other funding sources. The sponsored studies also were more likely to use patients with advanced disease, and were more often designed as "single arm" studies -- with all patients getting the same treatment, and no control group getting another treatment to compare effectiveness. The results were published in Cancer, a journal of the American Cancer Society.

The bottom line: Drug company sponsorship is common in the research and development arena, but the study authors say it should not influence research design and should never be an excuse for downplaying or ignoring important research findings, even the negative ones. Researchers working without industry sponsorship should weigh the pros and cons of any experimental drug or therapy, and make sure that any negative study findings receive adequate attention. Cancer patients should always talk to their doctor about the benefits and risks of joining any research study.

Citation: "Association Between Pharmaceutical Involvement and Outcomes in Breast Cancer Clinical Trials." Published online Feb. 26, 2007, in Cancer. First author: Jeffrey Peppercorn, MD, MPH, University of North Carolina-Chapel Hill, NC.