An advocacy group has filed an ethics complaint with the University of Texas MD Anderson Cancer Center for failing to disclose results of a clinical trial that was completed 16 years ago, arguing the failure violates the Helsinki Declaration.
At issue is a study that was begun in 1998 to determine whether a single treatment of stereotactic radiosurgery, also known as targeted irradiation, would prolong life for outpatients with metastasizing brain tumors. The study, which was sponsored by MD Anderson, was finished in 2005, according to the ClinicalTrials.gov database. But MD Anderson researchers never published results on the site.
This may have gone unnoticed if it were not for the Institute for Quality and Efficiency in Health Care, or IQWIG, an independent German agency that assesses the effectiveness of medicines. The agency sought to compare the treatment with surgery or radiation of the entire brain, but could not offer an opinion due to a lack of available study data, even though the MD Anderson trial and one other had been completed years ago.
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