The Problem of Bias in Clinical Research
It should come as no surprise that in the United States, the pharmaceutical industry spends a great deal of money on clinical trials. In fact, among the 83,482 trials registered with ClinicalTrials.gov from 2007 to the start of 2012, 42% were at least partially funded by industry. And as this research influences the recommendations that healthcare providers make about drugs and other interventions, it’s important that reports from clinical trials are transparent as to the funding source.
This issue was brought to light recently by a new Cochrane Systematic Review, suggesting that industry-sponsored clinical trials present a more favorable picture of the effects of drugs and medical devices than those trials supported by non-industry sources.
The researchers carried out a systematic review of 48 studies on drugs and medical devices. The drugs and devices being studied were prescribed for a wide range of different diseases and conditions, from heart disease to psychiatric conditions, and were compared to placebos or other treatments. Industry-supported studies reported greater benefits and fewer harmful side effects compared to studies that were not industry sponsored. Papers describing industry-sponsored studies presented more favorable overall conclusions, and the results and conclusions sections in these papers were less likely to agree.
Because the outcomes of clinical trials can influence the recommendations you make regarding drugs and other medical interventions, Hayes contends that you should be aware of a study’s bias as you make your decisions about what products and devices to purchase, prescribe, or recommend to colleagues or patients.
The identification and reporting of possible bias is an important ethical component for those among us who produce medical news. It’s easy to write a news story from a press release, a meeting abstract, or a news conference—which may or may not provide the study’s funding source or other potential sources of bias. And it’s easy to be lazy when you’re under a tight deadline. But easy isn’t always right.
We want to do the right thing. Just as the Hayes Knowledge Center evaluates evidence for a wide array of technologies, our News Service tries to identify and report funding biases that could affect a study’s conclusions. But now we’re going even further. As the Managing Editor of the Hayes News Service, I’m making a pledge for 2013. To the extent possible, our news commentaries will now include information about any stakeholder involved in the research that might introduce bias—including industry sponsors, advocacy groups and their sponsors, celebrity spokespeople, and even professional organizations. It may not always be easy, but it’s definitely the right thing to do.