Editorial: Clinical Trial Registration-Ear and Hearing Policy

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Excerpt

As the diversity of therapeutic interventions for ear and hearing disorders increases from hearing aids and auditory training to implantable devices, personal amplification systems, and pharmacological approaches, we expect the need for clinical trial outcome data to grow. Because of the direct implications for patient treatment, it is critical that the data from such research meet the highest scientific and ethical standards. Systematic public disclosure of descriptive information about clinical trials and straightforward access to scientific methods and findings are fundamental to the advancement of medical care and public health. For this reason, clinical trials registries were created to provide an official platform for the registration and cataloging of clinical trials and to serve as a transparent, accessible, and searchable public resource.
Clinical trials are defined by The World Health Organization (WHO) as “any research study that prospectively assigns human participants or groups of humans to one or more health-related intervention to evaluate the effects on health outcomes” [http://www.who.int/ictrp/en/; International Clinical Trials Registry Platform (ICTRP)].
In accordance with the International Committee of Medical Journal Editors (ICMJE) guidelines, we instituted a policy in June 2016 that requires registration of clinical trials in a public trails registry at or before the time of enrollment of the first study participant as a condition for publication of research findings generated by the clinical trial in Ear and Hearing. Consistent with the WHO and the ICMJE, this requirement applies to any research study that prospectively assigns individuals or groups of individuals to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relation between a health-related intervention and a health outcome. Health-related interventions include those used to modify a biomedical or health-related outcome (e.g., drugs; devices; surgical procedures; behavioral, educational, dietary, and quality improvement interventions; and process-of-care changes). Health outcomes involve any biomedical, pharmacokinetic, or health-related measures collected from participants, including adverse events.
Requiring that investigators register a clinical trial before it begins, submit study updates and summary results, and make relevant information available to the public, serves the entire community, benefiting researchers, clinicians, patients, and study participants (Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors 2004; Zarin et al. 2015). The requirement of clinical trial registration has been widely accepted as an effective way to help mitigate publication bias and other reporting biases by preventing selective publication and selective reporting of research outcomes. Underreporting of research findings can be potentially harmful to patients and a form of scientific misconduct, thus trial registration is increasingly being required as a condition for ethical approval [Chalmers 1990; International Clinical Trials Registry Platform (ICTRP); Simes 1986; Zarin et al. 2005]. In addition, trial registration facilitates the dissemination of information to clinicians and potential participants, helps to avoid duplication of research efforts, and provides context for users of the medical literature that enhances understanding of reported findings. It also allows for more inclusive systematic analyses that combine data from multiple trials of similar interventions. Importantly, the registration process fulfills ethical obligations to participants and the research community, promotes more efficient allocation of research funding, and assists institutional review boards in their evaluations of new studies by enabling them to consider new proposals in the context of other relevant research (Zarin et al. 2015).
The scientific research community has embraced efforts to make trial registration compulsory. The Food and Drug Administration Amendments Act of 2007 specified the requirements for registration and instituted penalties for noncompliance (Food and Drug Administration Amendments Act of 2007, Public Law 110–85 2007). The National Institutes of Health established a policy that requires registration of a clinical trial to ClinicalTrials.
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