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Data on failures in reporting to ClinicalTrials.gov

A Stat investigation has found that “prestigious medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments.”

"The violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer."

Other reporters can do their own stories about institutions and companies in their areas using the data that Stat obtained and is making available through AHCJ.

The data includes 98 universities, nonprofits, and corporations that served as sponsors or collaborators on at least 20 trials subject to federal disclosure requirements between 2008 and Sept. 10 of this year (when the data were downloaded).

About using the data

Reporters using this data should cite a "STAT analysis of ClinicalTrials.gov data" and link to its story at http://www.statnews.com/2015/12/13/clinical-trials-investigation/.

The first tab shows all the academic and nonprofit institutions nationally, plus the national averages for each category. Other tabs show organizations for states and regions that have multiple institutions or companies.

Column D: "Trials that require results", shows the number of trials for each entity that under federal law were required to report results within one year of completion of the trial.

Column E: "% of those trials with no results posted", is the percentage of the trials in column D for which results were not reported as of Sept. 10, 2015.

Column F: "For late results, average days late", looks at trials that were posted late (more then one year after the trial was completed) and how late on average those trials were.

Column G: "% of those trials with no results or results posted late", is the percentage of trials in column D for which there were either no results posted, or the results were posted late. This was the bottom-line measure of performance in our analysis, because an entity that fails to report the results of a trial subject to the reporting requirement or reports the results late is in violation of federal law.

Here is how Stat did the analysis:

To assess reporting performance on the National Institutes of Health website ClinicalTrials.gov, Stat downloaded the site’s entire dataset of about 200,000 trial records on Sept. 10, 2015. The law governing the site contains many exceptions that allow results to be withheld, so Stat filtered the data to exclude all such trials. In other cases, legal deadlines to supply results had not yet arrived, and those trials were set aside as well. That left about 9,000 trials for which results were clearly due under the law.

Stat used a conservative standard, not counting any study that was not clearly required to report results. For example, pharmaceutical companies can request extensions to the reporting rules for experimental drugs. The FDA approves or denies those extensions, without making the decisions or their timing public. Stat obtained from the NIH a list of trials for which extension requests had been made and, in keeping with the conservative approach, assumed all of those trials had been granted extensions. It did not regard any of their results as overdue.

Performance was measured based on trials that an institution either collaborated on or sponsored. Collaborators don’t normally supply results to ClinicalTrials.gov. But Stat included collaborators’ trials because they act as funders, coresearchers, or principal investigators — roles that warrant some responsibility for ensuring that trial data is reported in a timely fashion. In nearly all cases, trials sponsored by an institution comprised all or the vast majority of its trials.

Data for pharma companies acquired by other firms since 2008 were included in the combined entity’s totals. For companies spun off from parent firms, trial data were assigned according to which company retained control over the trial.

For any questions, reporters should contact reporter Charles Piller at charles.piller@statnews.com.

Get the data here.