Transparimed, an advocacy group focused on clinical trial transparency, has filed an ethics complaint with the University of Texas MD Anderson Cancer Center in Houston over undisclosed results from a clinical trial completed in 2005.
The advocacy group announced it had filed the ethics complaint Oct. 14.
The trial at the center of the complaint began in 1998 and recently garnered attention when the German Institute for Quality and Efficiency in Healthcare, known as IQWiG, tried to evaluate whether a single treatment of stereotactic radiosurgery would prolong the life of patients with brain metastases.
The institute was unable to make a conclusion due to lack of available study data, despite the completion of a trial led by MD Anderson and a separate trial from the National Institute of Neurological Disorders and Stroke, it said in a Sept. 17 news release.
Both of the trials are marked as completed on clinicaltrials.gov, though results have not been uploaded or published in a scientific journal.
In 2007, the U.S. passed a federal law requiring trial sponsors to disclose results, though it only applies to trials completed after it was adopted.
"MD Anderson has one of the world’s largest clinical trials portfolios and is fully compliant with current federal reporting requirements," a spokesperson said in an Oct. 18 statement sent to Becker's.
"We support efforts to enhance clinical trial transparency based on current laws and best practices, and we believe it is important to publish our clinical trials data – positive and negative.
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."
Mulitple attempts by the trial's principal investigator to submit the data for publication in a peer-reviewed journal were unaccepted, the statement 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," MD Anderson's statement said. "This is counter to the principles of scientific exchange."
Transparimed's ethics complaint argues MD Anderson's failure to share its clinical trial results is a violation of the Declaration of Helsinki, which states researchers have a duty to make results from studies involving human participants publicly available. While the declaration was created by the World Medical Association and sets ethics rules for medical research, it does not have the ability to enforce its rules.