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Medical Journals Lack Registration for Clinical Trials Performed in the US
10/24/2012 (press release: ramaefule) // Chicago, IL, United States of America // Rob Amaefule
Dr. Nalini Rajamannan Cardiologist, Sacred Heart Cardiology, Chicago IL, has discovered evidence indicating that human clinical trials testing heart devices during open heart surgery are being published without following regulatory standards.
Registration prior to testing of medical devices in patients on Clinicaltrials.gov is a requirement prior to publication in medical journals. Laws governing clinical studies in the United States require registration on www.ClincalTrials.gov.
After registration, each study receives a clinical trial identification number, which permits publication rights in medical journals. In July 2005, the International Committee of Medical Journal Editors (ICMJE) began to require trial registration as a “condition of publication.” Evidence shows that at least two surgical trials were conducted at major academic centers in the US, without the ClinicalTrials.gov registration.
The first trial tested a device called the IMR, which was published in the American Heart Association’s (AHA) medical journal in 2006 called Circulation. The second trial tested a device called the Myxo, which was published in the American Association Thoracic Surgeon’s (AATS) medical journal in 2008 called The Journal of Thoracic and Cardiovascular Surgery.
To date, neither study is certified with a clinical trial registration number, which is required for publication as per ICMJE requirements. After asking the AHA, whether proof of the clinical trials registration number, is necessary upon any enrollment or publication in Circulation, the AHA confirmed saying, “Human Studies: Indicate that the study was approved by an institutional review committee.”
Review of the Institutional Review Board Records from Northwestern University indicates that the approval arrived in 2005, two years after the initial enrollment of patients which began in 2003 into the clinical trial. The trial was subsequently published in the American Heart Association Journal, Circulation in 2006.
After requesting for comment by the AATS, the editor has stated: "Regarding your request for a commentary about this issue, we would like to note that the Journal of Thoracic and Cardiovascular Surgery is not an investigative agency. The Journal essentially has no comment."
After reading the ICMJE website on uniform requirements for publications it appears that the editors of Circulation and JCTVS have the responsibility of investigating any possibility of violations of patients’ rights. “If substantial doubt arises about the honesty or integrity of work, either submitted or published, it is the editor’s responsibility to ensure that the question is appropriately pursued, usually by the authors’ sponsoring institution. If this method of investigation does not result in a satisfactory conclusion, the editor may choose to conduct his or her own investigation”.
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