MD Anderson Cancer Center Called Out Over Failure to Post Clinical Trial Results
A U.S. advocacy group has filed a formal ethics complaint against MD Anderson Cancer Center for declining to publicly post the results of a clinical trial that wrapped up 16 years ago.
The trial, which compared the effectiveness of surgical resection and stereotactic radiosurgery in treating brain cancer, ended in 2005, according to ClinicalTrials.gov. But the issue at hand is that MD Anderson Cancer Center has, to date, not made the results of the study public.
It’s another example of mounting pressure on the clinical research industry to be more transparent with their trial data. TranspariMED, the group that filed the complaint, argued that MD Anderson violated the Declaration of Helsinki by failing to post the results of the study.
“Unreported clinical trial results make no contribution to medical progress and thus constitute research waste,” the group said in its complaint. “This violation would not have occurred if MD Anderson as an institution had had appropriate policies, systems and safeguards in place.”
In addition to not posting the results publicly, a representative with the cancer center also reportedly refused a request by outside researchers in Germany to share the results with them, the group claims.
A U.S. law was enacted in 2007 requiring sponsors to report their results and a rule came into effect in 2017 outlining the requirements for trial registration and results submissions. Currently, trials must be registered on ClinicalTrials.gov no later than 21 days after initiation and results must be posted within a year of completion (or within 30 calendar days after FDA approval, licensure or clearance).
MD Anderson defended its clinical trial reporting practices in a statement to CenterWatch Weekly, contending that it tried multiple times, to no avail, to get the trial data peer-reviewed and accepted for publication.
“While MD Anderson’s Compliance Office is reviewing the complaint, it is important to note that the study referenced was terminated years before the federal regulations to publish the results went into effect. It is not normal practice for any organization to reopen a completed study to fulfill a requirement that did not exist at the time. Additionally, the data have not been accepted for publication despite multiple efforts and submissions by the PI,” the center said. “Without peer review, we believe that the wide distribution of inconclusive clinical study results is inappropriate as these can lead to misleading interpretation and negative impact for patients. This is counter to the principles of scientific exchange.”
Regulators have recently begun cranking up the heat on sponsors and investigators who fail to publicly post results and industry in general has made data transparency more of a goal to reach. The FDA issued its first-ever notices of noncompliance this year that carry the weight of monetary fines if results aren’t posted on ClinicalTrials.gov (CenterWatch Weekly, Sept. 13).
Access the TranspariMED complaint here: https://bit.ly/3ALEnZu.