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Stanford violates federal law requiring disclosure of clinical trial data

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A recent STAT News investigation stated that Stanford has violated a federal law requiring the disclosure of applicable clinical trials and observational studies involving human subjects on ClinicalTrials.gov. By failing to report the results, the institutions deprive the public of data on medical treatments and their efficacy.

ClinicalTrials.gov (CT.gov) is a website that allows the public to access information on clinical and observational studies on a variety of conditions. Information is supplied by the sponsors or principal investigators of each study and can be submitted either at the beginning of the study and updated throughout the course of the study or at the end of the study.

The law requires that recipients of federal medical research funds from the National Institutes of Health report trial results to CT.gov. The legislation was intended to promote transparency within the pharmaceutical industry, which has hidden negative trial results in the past.

Stanford’s role

Stanford reported data for 26 out of 82 applicable trials, according to the STAT News article, which analyzed data from institutions with at least 20 human experiments since 2008. Of the 26 reported studies, professors submitted results by their respective deadlines in only four cases. However, according to Harry Greenberg, senior associate dean for research at Stanford, the University will increase support for faculty members to allow for disclosing trial data in a timely manner through the CT.gov website, which has specific instructions for submission.

Greenberg stated that Stanford plans on being more like Duke Medicine, a major research institution that does well in terms of CT.gov reporting. According to a paper from Duke titled “ClinicalTrials.gov Reporting: Strategies for Success at an Academic Health Center,” after creating a group with three full-time staff members who ensured compliance with the law and offered hands-on support for study teams, registration and results reporting increased.

Stanford has devised a two-step plan similar to Duke’s. First, Stanford will hire a small office strictly for ensuring compliance with CT.gov. The people who work in the office will help the faculty understand the process of data reporting better and let the faculty know when they are out of compliance. Second, there will be a series of consequences for faculty members who fail to report their study results. The specific consequences are still being discussed among faculty leadership.

Current issues with CT.gov

Stanford spokeswoman Lisa Lapin was quoted in the STAT News article as having said that often faculty members currently go “above and beyond” their capacity with regards to their workload, so they sometimes fail to report study results. The NIH estimates that it takes about 40 hours to report data.

“We want to and will do what is required, but there’s almost certainly some room for improvement with the structure of the current reporting format of CT.gov,” Greenberg said. “The key with all regulations is to try to understand and ensure that the increased cost, time and effort of the regulations warrants the effort.”

“CT.gov 100 percent has the right idea — the effort to enhance the clinical trial results reporting is absolutely there for the right reason,” he added. “But something isn’t perfect when 80 percent of major academic medical institutions are currently below 50 percent in their results reporting.”

Though research institutions publish their data in medical, peer-reviewed journals, it does not satisfy the CT.gov requirements. People may decide to only publish certain trials in journals, omitting unfavorable results. So while CT.gov may not be perfect, it can still be a better option than medical journals because all results — positive and negative — are disclosed, giving the patients, healthcare providers and the public access to more information.

“ClinicalTrials.gov is meant to be a comprehensive set of information that is at least very supplementary to medical journals, which are incomplete and often unreliable sources,” said Charles Piller, the author of the original STAT News article. “And they are an essential repository for information about medical research. Clearly, ClinicalTrials.gov has a lot of information to add to the mix that you can’t possibly get in medical journals.”

Additionally, journals also often require a costly subscription free, whereas CT.gov is free and open to the public. By standardizing how results are published, CT.gov also allows for easier comparisons across studies.

“What is clear is that it’s important for those who do human subjects research to try to ensure that the results are generalizable so that others can see their results, think about them and build on them so the findings will not be buried or lost,” Greenberg said. “This is a critical issue.”

 

Contact Anne-Marie Hwang at amhwang ‘at’ stanford.edu.

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