ClinicalTrials.gov and the Patient Consumer
Open AccessAbstractAt a time when the public, including disease specific advocates and interest groups were demanding greater public access to clinical trials, Congress mandated the creation of a publicly available clinical trial registry in a provision of The Food and Drug Administration Modernization Act (FDAMA). The primary purpose of this provision of the law is to improve the public's access to clinical trials. The law's main objective was to ensure that individuals with specific diseases and conditions would have the opportunity to locate experimental treatments that would not otherwise be available to them, but for participating in a clinical trial. Often times patients with rare or serious diseases have few approved therapies on the market available to them, and these experimental trials can serve as an additional, and sometimes life-saving, therapy option in these cases. Future legislation looked to expand this patient access to clinical trial research through the mandating of the ClinicalTrials.gov website. This paper explores the intent of these laws, and whether or not Congress's goal has been achieved through this legislation. Through a survey created by the author and distributed to stakeholder groups, patients, physicians and the public at-large, this paper discusses the possible strengths and weaknesses of the ClinicalTrials.gov website in its current form. The paper also reviews other clinical trial registries, and proposes recommendations for improving the ClinicalTrials.gov website. The paper recommends that electronic health records (EHRs) being mandated by the HITECH Act, include specifications which allow for physicians to see real-time information on patients regarding eligibility for participation in various clinical trials being conducted throughout the Nation.
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