Clinical Trial Survey Shows Industry Supported Trials are Successful

The Annals of Internal Medicine published an article entitled “Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov,” which examined whether the funding source of these certain clinical trials was associated with favorable published outcomes.

The observational study of safety and efficacy trials was designed to look at anticholesteremics, antidepressants, antipsychotics, proton-pump inhibitors, and vasodilators conducted between 2000 and 2006. Consequently, among 546 drug trials, 346 (63%) were primarily funded by industry, 74 (14%) by government sources, and 126 (23%) by nonprofit or nonfederal organizations.

According to the study results, trials funded by industry were more likely to be phase 3 or 4 trials (88.7% across groups), to use an active comparator in controlled trials (36.8% across groups), to be multicenter (89.0%), and to enroll more participants (median sample size, 306 participants across groups). Overall, 362 (66.3%) trials had published results.

Consequently, the fact that industry-funded trials reported positive outcomes in 85.4% of publications, compared with 50.0% for government-funded trials and 71.9% for nonprofit or nonfederal organization–funded trials should not be surprising. Later phase trials (Phase III and IV) largely funded by industry have a higher probability of success than early stage trials funded by government and foundations. By trying to associate the more favorable outcomes with success in these phases, which were funded largely by industry, the authors are comparing apples to oranges, and end up writing a paper that oranges have more juice than apples.

The study also found that trials funded by nonprofit or nonfederal sources with industry contributions were also more likely to report positive outcomes than those without industry funding (85.0% vs. 61.2%). Rates of trial publication within 24 months of study completion ranged from 32.4% among industry-funded trials to 56.2% among nonprofit or nonfederal organization–funded trials without industry contributions.

Despite these findings, the study was limited because additional information on study protocols and comprehensive trial results were not available to further explore underlying factors for the association between funding source and outcome reporting.

In fact, one of the researchers, Florence Bourgeois, a faculty member in the division of emergency medicine at Children’s Hospital in Boston, told Newsweek that they didn’t even “know for sure” that industry funding was a factor because it “may be other things that could sway results.” For example, she noted that instead of commercial funding creating bias in trials, it could be “the questions that investigators choose to ask or the type of patient selected or how long the patient population is followed.”

Even though it is clear that other factors have a strong potential to influence clinical trials, Dr. Bourgeois asserted that the study justified the need for more oversight and additional information about the way the trials are designed. She stated that it would be “helpful if study protocols were posted in ClinicalTrials.gov or comprehensive FDA review material of trials reviewed in the drug approval process for every medication made available.”

What is troubling about this study is that it ignores some very simple and obvious facts. First, industry trials are more successful than government. What is that saying about the expertise and level of science being conducted by our own government when our agencies are right half the time and industry is right 85% of the time? 

Second, it is important to realize that the success of industry trials is based on the fact that industry spends money on products and studies on those products when there is a high probability of success. That is how all companies work: invest in something profitable. Investing in health care is no different than any other business, except for the fact that numerous drug and device companies work on orphan drugs and devices for rare diseases, and donate their time, services and products for philanthropic purposes.

Third, the fact that we are seeing more positive results benefits patients because the more beneficial results we see, the more patients will benefit from the drugs that work.  

Fourth, companies are focused on developing and testing drugs as efficiently and effectively as possible to bring products to patients faster. The fact that there may be bias in a study designed by commercial funding to accomplish that purpose should not be shocking because companies don’t have the resources to waste time and money on poorly designed trial, even though the government has unlimited resources and can waste all they want.

Fifth, the job atmosphere and pressure in government versus private industry are exactly the opposite. Where as no one is going to lose their government jobs for poor study design, companies can fail, and jobs can be lost in seconds for trials and products that fail. And finally, one of the reasons why industry trials are so promising is because non profits are less motivated and knowledgeable to conduct studies that are successful.

In the end, if the author was true to his own logic it should follow that if government is having less successful clinical trials, shouldn’t they be the ones needing more oversight?

Everything in society comes with inherent risks and benefits. Just look at all the recalls of toys and cars. Should we believe that companies were biased in creating ways for kids to have fun and adults to get to work to support their families? This study tries to associate biased results with the people who funded them. Does that mean that all of our politicians are biased by the people who contributed campaign donations to them?

Companies survive and exist to make people healthier and live longer. That’s their business, and attacking them for being more successful than government seems childish. Instead of wasting their time figuring out which factors cause trial results to be “biased,” it would probably help if the government determined what industry is doing right to have such success, and what they are doing wrong.