Author + information
- Christopher M. O’Connor, MD, Editor-in-Chief, JACC: Heart Failure∗ ()
- ↵∗Address for correspondence:
Dr. Christopher M. O’Connor, Editor-in-Chief, JACC: Heart Failure, American College of Cardiology, Heart House, 2400 N Street NW, Washington, DC 20037.
Each day we ask our patients and volunteers to participate in clinical trials to investigate a variety of questions, such as whether a therapy works or not or whether one is better than another. It is a moral and ethical responsibility of investigators to register and publish the results of all clinical trials. The Declaration of Helsinki, the World Medical Association’s declaration on the principles of clinical research, states that the principal investigator is responsible for registering and publishing the trial results (1). Section 801 of the Food and Drug Administration Amendment Act of 2007 (FDAAA 801) signed by President George W. Bush summarizes the clinical trial registration and results submission requirements (2). Registration of Applied Clinical Trials (ACT) is required for all trials initiated after September 27, 2007. Trials required to be registered include controlled clinical trials other than phase I studies of FDA-regulated drug, device, or biologic products. Trials having one or more sites in the United States, and trials conducted under FDA investigational new drug or investigational device exemption applications are required. In 2017, the FDA commissioner Dr. Robert Califf provided additional support for FDAAA 801 by requiring the enforcement of fines for those trials not registered or reported (3).
Today, 1,100 of 3,400 (32%) of clinical trials have not been registered and are eligible for fines and penalties totaling millions dollars, yet there is no report of penalty collections to date under this new requirement (4).
What can we do better as journal editors in this capacity?
First, we should pose no barriers or penalties for investigators who publish the results on the Clinical Trials.gov website before publishing in the respected journal. Second, we should standardize the information and data required in the journal to be harmonized with the requirements of FDAAA 801.
Finally, we should actively solicit and facilitate trial publication of unpublished completed clinical trials. In this effort, we should encourage post hoc registration and publication of the results with encouragement and ease of process. In doing so, we will best serve our patients by understanding the full range of medical knowledge accumulated from all trials; make better clinical decisions; avoid missing potential opportunities for innovation; and avoid repeating the mistakes of previous clinical investigations. In addition, we owe it to the patients who participated to provide the results of trials. The Dead Letter Office has published more than a dozen trials that have been lying dormant (5). There may be hundreds of outstanding heart failure trials not yet published. As journal editors, we can do better, and we owe this to our patients.
- 2019 American College of Cardiology Foundation
- ↵U.S. Food and Drug Administration. Food and Drug Amendments Act of 2007. Available at https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-amendments-act-fdaaa-2007. Accessed July 9, 2019.
- ↵U.S. Food and Drug Administration. FDA Reauthorization Act of 2017. Available at https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/fda-reauthorization-act-2017-fdara. Accessed July 9, 2019.
- ↵(2014) All Trials. All Trials Registered | All Results Reported. Available at:. http://www.alltrials.net. 2462019.
- O’Connor C.M.