Clinical drug trials funded by industry are more likely to publish favorable results about the drug in question, according a new study out of Children's Hospital in Boston — and that finding is prompting calls for more rigorous oversight of how drug trials are designed.
The researchers found that when pharmaceutical firms or other industry players pay for a drug trial, that drug shows positive results 85 percent of the time. That's compared to 72 percent for trials funded by nonprofits or non-federal organizations, and 50 percent for government-funded trials.
The study's lead author, Florence Bourgeois, said that disparity could be occurring because whoever funds a drug trial frequently helps design it, and it's possible to manipulate the design.
"There are a number of things that investigators designing trials can do that can then subsequently add up to factors that result in more favorable results," said Bourgeois, an emergency medicine physician at Children's Hospital and an instructor of pediatrics at Harvard Medical School.
Bourgeois said those manipulative techniques may include:
- Asking selective questions and omitting other questions
- Focusing only on certain aspects of a drug's performance and ignoring others
- Cherry-picking which patients are included in the study and excluding those who might react poorly to a drug
- Deciding how long a study population is followed, which could enable researchers to end a study before troubling side effects begin to surface
"I wouldn't say these things are necessarily deliberate," she added. "Our findings simply raise concerns about whether there is an inherent conflict of interest if you have pharmaceutical companies designing and conducting trials to validate drugs they are also seeking to market, and standing to gain quite a bit from good results."
Biased drug trials can compromise the integrity of medical research and potentially put harmful medications on the market.
Yet preventing pharmaceutical firms from funding drug research is an impractical solution, Bourgeois noted, because industry pays for the lion's share of most clinical trials since the for-profit sector generally has deeper pockets than government and nonprofit funders.
Federal regulators have attempted to make drug trials more transparent by more closely tracking their existence and their clinical outcomes. Still, funding sources tend to get limited scrutiny. So even more oversight and disclosure are needed to ensure truly objective drug trials and guarantee unbiased results, Bourgeois said.
To conduct their study, the researchers analyzed nearly 550 drug trials conducted between 2000 and 2006 and listed with ClinicalTrials.gov, a Web-based federal registry of clinical trials.
The co-author of the study, which appears in the Annals of Internal Medicine, is Kenneth Mandl.
Here's the study (Scribd):
This program aired on August 3, 2010. The audio for this program is not available.