Abbott understands that a critical component of medical product development is the conduct of clinical trials (also referred to as clinical studies) in humans to evaluate the safety and effectiveness of medical products for the diagnosis, treatment and prevention of disease.
Abbott is committed to transparency and sharing important information about the clinical trials we sponsor. We recognize that there are important public health benefits to making clinical trial information available to healthcare providers, patients and the public. Therefore, Abbott has adopted these principles regarding the disclosure of information relating to the clinical studies that we sponsor across our diverse businesses.
Our registrations and results disclosures will adhere to all applicable national laws and regulations in countries where we operate, around the world.
Clinical Trial Registrations
Abbott will register all applicable/covered clinical trials, regardless of outcome, in a publicly accessible clinical trials registry, such as www.ClinicalTrials.gov. For branded generic pharmaceuticals, this means that we will register interventional clinical studies in patients. For medical devices and diagnostics, this means we will register interventional clinical studies of health outcomes and pediatric post-marketing surveillance studies, as designated by national laws and regulations.
Clinical Trial Results Disclosures
Abbott will disclose the results of all applicable/covered clinical trials, regardless of outcome, in a publicly accessible clinical trials results database, such as www.ClinicalTrials.gov. For branded generic pharmaceuticals, this means that we will report results for interventional clinical studies in patients. We also will report the results of any exploratory pharmaceutical clinical studies if the findings have significant medical importance (e.g., an important safety finding). For medical devices and diagnostics, this means we will report results for interventional clinical studies of health outcomes and pediatric post-marketing surveillance studies, as designated by national laws and regulations.
Clinical Trial Data Sharing
In an evolving regulatory environment around sharing clinical trial data for research purposes, Abbott will continue to engage with stakeholders regarding approaches for sharing clinical trial data with scientific and medical researchers to advance medical science, while protecting information that is confidential for patients, our partners and our company.
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