Major research institutions fail transparency requirements, and pharma's not much better
- STAT analysts investigated whether medical researchers from 98 universities, nonprofits, and corporations properly reported clinical trial results via ClinicalTrials.gov, in accordance with a 2007 federal law. They found that most clinical trial data is not properly updated in a timely manner (within one year) and often is not submitted at all
- Four of the top 10 recipients of NIH funding were among the worst performers: Stanford, the University of Pennsylvania, the University of Pittsburgh, and the University of California, San Diego.
- The FDA has authority to levy fines up to $10,000 a day per trial for late reporting. However, Stat found the agency has not levied any fines, a $25 billion opportunity cost.
Although medical research reporting rates have improved a great deal over the last several years due to greater awareness, most clinical trial results are still not reported within the one-year timeframe stipulated by the federal transparency law. For example, Memorial Sloan Kettering Cancer Center conducted 39 trials that required reporting results. Nearly three-quarters of those trials had no posted results on ClinicialTrials.gov, and 100% of the trials either had no posted results or results posted late.
Overall, academic institutions were less compliant with the law, reporting results late or not at all 90% of the time. Industry did slightly better, with only 74% of trial results reported late or not at all. Eli Lilly and AbbVie had relatively superior records, reporting more than 50% of results in a timely manner.
Researchers don't appear to be intentionally withholding clinical trial results from the public—though past high-profile cases focus on intentional withholding of critical adverse-event information. However, while results languish in a to-do pile, there are life-or-death cases where additional data can make a significant difference.
For example, medical researchers at Hoosier Cancer Research Network failed to report critical Avastin results from a breast cancer clinical trial back in 2009. Withheld information linked Avastin to hypertension, gastrointestinal toxicity, sensory problems, and pain in metastatic breast cancer patients. In 2011, the FDA revoked approval of Avastin for metastatic breast cancer—but the data from the trial did not become publicly available until 2013.
Medical researchers pointed to a lack of time to explain the failure to comply. However time-consuming, failure to disclose clinical trial results can harm patients
- statnews.com Failure to report: A STAT investigation