According to an editorial published in the January edition of the British Medical Journal, researchers often do not report relevant clinical trial data. The editorialists said the problem is missing data, “We are not dealing here with trial design, hidden bias or problems of data analysis- we are talking simply about the absence of the data. This behavior, in turn, biases research, wastes health care resources and many harm patients”. Editorialist Dr. Elizabeth Loder, MD, MPH added that data is not only missing but what is reported is often times done so “inadequately”.
One study found that fewer than half of trials funded by the National Institutes of Health (NIH) are published in a peer-reviewed journal within 30 days of trial completion. The same study showed that at 51 months one-third of the results remained unpublished. The current problem is not immune to the United States. A study in 2009 showed that only 22% of drug trials subject to mandatory reporting requirements disclosed their results within one year of the trial completion date.
The lack of reporting could potentially be a violation of the FDA Amendments Act of 2007. In regards to this possible violation, Rep. Henry A. Waxman (D-Calif.) and other congressmen wrote to the heads of the NIH and the FDA. In their note, they raised several questions such as why data was not being reported and why the $10,000 penalty per day had not been enforced.
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