Introduction
Clinical trial research does not just prove a drug’s safety and effectiveness for an FDA approval. Once a drug receives approval, the FDA-approved published results of clinical trial research become the basis of that new drug’s marketing campaigns.

Background
The accurate and complete reporting of clinical trial data remains a problem. The Food and Drug Administration Amendments Act (FDAAA) of 2007 and the Food and Drug Administration Revitalization Act of 2007 requires that all Phase II and later clinical trials register with the public database, ClinicalTrials.gov, and make their data available to the public through this site. Clinical trial data must be made available within 30 days of the registration date, and results of the trial must be published within 1 year after trial completion (FDAAA, Title VIII).

Data in the registry should include: the study description and design, the condition and treatment to be studied, participation requirements, and study location and contact information. In essence, registering on a public database can make it more difficult to pick and choose which data to publish, and then later use in marketing; however, not all registered trials post all their data on the registry, and not all trials publish their findings. Also, trials that are still in progress, or trials for drugs that do not get approved, do not have to publish their results.

Issue
Should all data from all clinical trials be registered and published?

Rules
Data from a clinical trial should be both registered and published if it contains accurate and important information about benefits, adverse effects, and prescribing.

Analysis
Not all clinical trial data must be made available to the public. Some studies will register and never publish their results, whether or not the trial had been completed. The Congressional Research Service reported in 2007 that both pharmaceutical companies and medical journals are hesitant to publish data that proves an investigative drug is “harmful or ineffective.”

And although a clinical trial may be registered on ClinicaTrials.gov, the rest of the study data may remain unpublished. One doctor noted that someone searching for a specific drug on the PubMed article database will only find articles that “the authors [chose]” to publish, regardless of the number of trials registered for that drug.

This past January, BMJ published a study that found that about 22% of the completed registered clinical trials that were required to post their result data actually published their results within 1 year. Most of these were trials sponsored by pharmaceutical companies or “later-phase trials.” Another BMJ meta-analysis of study data for 9 drugs found that the unpublished data showed lower drug efficacy in 46% of the cases studied.

This misreporting or lack of complete published data has a huge impact on the messages of later promotions and the public’s perceptions of the drug. In 2008, GlaxoSmithKline settled a case in the US for $40 million, after being accused of misleading the public by withholding studies showing their antidepressant Paxil was unsuitable for children. The drug, which was being prescribed off-label for patients under 18, had actually been found to increase suicidal behavior in younger patients.

A 2010 analysis of Pfizer’s antidepressant Edronax’s 13 clinical trials, included 8 “previously unpublished” trials, and found that 74% of patient trial data was not published, and that the risks of the drug outweighed the benefits so much that the authors concluded Edronax (which was never approved in the US) to be “ineffective and potentially harmful.” These cases might have never come to light, and there can be many more like them, if the full data from every clinical trial remains unpublished. In order for clinical trials to remain the “gold standard” for FDA approval and a valuable resource for the public to gain information, all data must be published.

Conclusion
All data from every clinical trial should be registered and published as soon as possible, to ensure the greatest clarity and balance of the benefits and risks of the drug and to guarantee better-educated prescribers.

For more information on this issue, contact the Kulkarni Law Firm.