Researchers and drug companies are currently allowed withhold the results of a clinical trial and other information from doctors and patients if they choose.
This makes it possible for them to mislead doctors about the risks and benefits of a given medication or treatment.
While this may not be an issue you’ve heard a lot about, the problem has been widely discussed and is well documented within the profession. Unfortunately, government legislators have failed to engage on this issue.
What percent of clinical trials are suppressed?
It’s currently estimated that close to half of all clinical trials are not published in academic journals.
Researchers and companies are twice as likely to publish studies with positive results as they are those whose results run contrary to their expectations. This is an industry-wide issue that greatly impacts clinical practice.
Most drugs that are currently in use were approved several years ago, and the rates of missing data greatly impact current clinical practices. In spite of this, the rate of data reporting has not improved.
For example, one review of studies funded by the National Institute of Health found that only 65 percent of the clinical trials conducted in 2008 were published in a peer reviewed journal
In 2008, the FDA began requiring the results of all clinical trials to be published in a peer-reviewed journal within a year of completion. Unfortunately, no professional audit to ensure compliance was conducted, and an audit published in 2012 showed that as many 80 percent of trials failed to comply with the new rule.
To make matters worse, no fines have been issued to punish researchers or drug companies for failure to comply.
The AllTrials.net campaign initiative hopes to reverse this practice. Created by Bad Science, BMJ, Centre for Evidence-based Medicine, Cochrane Collaboration, James Lind Initiative, PLOS and Sense About Science, the site was launched in 2013 and has issued a call for all clinical trials, past and present to be registered and have their results published and reported.
The detailed plan available on the alltrials.net website outlines procedures for streamlining the registration system for clinical trials. They suggest standardizing registration by establishing and utilizing a number of global centers.
AllTrials has also planned for the enforcement and monitoring of clinical trials taking place, making it impossible for trials to obtain government funding or permission to conduct a trial without proving that they have completed registration.
To provide further incentive for companies conducting trials, applications for reimbursement should be pursuant to having followed the registration requirement.
As an added bonus for the current medical industry, they have also provided plans for the registration and publication of all past clinical trials that have previously avoided these requirements. This could make a big difference in the lives of current medical patients, and help doctors make more informed decisions regarding treatment methods for a number of illnesses.
The issue of clinical trial registration and publication is simply too big to ignore.
It is imperative for doctors to be able to see all available data in order to ensure and protect the health and safety of their patients.
It also allows them to avoid prescribing expensive treatments that drain a patient’s budget when a less expensive or even generic medication can provide results that are just as good or even superior.
The public deserves a medical profession that is well-informed on all of the results of clinical trials; not simply those that researchers and drug companies want them to see.
For more information on the AllTrials campaign and to sign the petition, visit the website at www.alltrails.net and help make a difference. They need a million signatures. Please add yours.
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