Design and Implementation of a National Clinical Trials Registry

McCray, Alexa T.; Ide, Nicholas C.

doi:10.1136/jamia.2000.0070313

Cited by 80 publications

(55 citation statements)

References 14 publications

(12 reference statements)

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“…[12][13][14][15][16] It is the most robust of the international clinical trial registries, currently containing detailed information on more than 120 000 clinical research studies conducted in more than 175 countries. 17 Originally created to increase public awareness of clinical trials and improve the conduct and monitoring of research, 18 the registry now serves as a mandatory repository for information on most clinical studies conducted under US regulatory auspices. 19,20 In addition, registration with ClinicalTrials.gov or another comparable registry is a prerequisite for publishing study results in many peer-reviewed journals.…”

Section: He Cost Of Cancer Care Ismentioning

confidence: 99%

Characteristics of Oncology Clinical Trials

Hirsch¹,

Califf²,

Cheng³

et al. 2013

JAMA Intern Med

158

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Clinical trials are essential to cancer care, and data about the current state of research in oncology are needed to develop benchmarks and set the stage for improvement. Objective: To perform a comprehensive analysis of the national oncology clinical research portfolio. Design: All interventional clinical studies registered on ClinicalTrials.gov between October 2007 and September 2010 were identified using Medical Subject Heading terms and submitted conditions. They were reviewed to validate classification, subcategorized by cancer type, and stratified by design characteristics to facilitate comparison across cancer types and with other specialties. Results: Of 40 970 interventional studies registered between October 2007 and September 2010, a total of 8942 (21.8%) focused on oncology. Compared with other specialties, oncology trials were more likely to be single arm (62.3% vs 23.8%; PϽ.001), open label (87.8% vs 47.3%; P Ͻ .001), and nonrandomized (63.9% vs 22.7%; P Ͻ .001). There was moderate but significant correlation between number of trials conducted by cancer type and associated incidence and mortality (Spearman rank correlation coefficient, 0.56 [P=.04] and 0.77 [P=.001], respectively). More than one-third of all oncology trials were conducted solely outside North America.Conclusions and Relevance: There are significant variations between clinical trials in oncology and other diseases, as well as among trials within oncology. The differences must be better understood to improve both the impact of cancer research on clinical practice and the use of constrained resources.

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Section: He Cost Of Cancer Care Ismentioning

confidence: 99%

Characteristics of Oncology Clinical Trials

Hirsch¹,

Califf²,

Cheng³

et al. 2013

JAMA Intern Med

158

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“…Additional content manager components allow us to interrelate, index, and cross-reference the information with data from other high-quality, publicly available sources and publish it on the public site. The architecture is adapted from NLM's ClinicalTrials.gov, 33 although substantial modifications were needed for the specific nature of the Genetics Home Reference project. We will concentrate our discussion on those items that are unique to the Genetics Home Reference system.…”

Section: System Descriptionmentioning

confidence: 99%

Design of Genetics Home Reference: A New NLM Consumer Health Resource

Mitchell

Fun

McCray

2004

J Am Med Inform Assoc

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The authors have developed the Genetics Home Reference, a consumer resource that addresses the health implications of the Human Genome Project. The research results made possible by the Human Genome Project are being made available increasingly in scientific databases on the Internet, but, because of the often highly technical nature of these databases, they are not readily accessible to the lay public. The authors' goal is to provide a bridge between the clinical questions of the public and the richness of the data emanating from the Human Genome Project. The Genetics Home Reference currently focuses on single gene or polygenic conditions that are also topics on MEDLINEplus, the National Library of Medicine's primary consumer health site. As knowledge of genetics expands, the interrelationships between genes and diseases will continue to unfold, and the site will reflect these developments

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“…16 A Web-based registry, ClinicalTrials.gov, was established in 2000 by the National Library of Medicine on behalf of the National Institutes of Health as a result of this law. 17,18 Although FDAMA 113 mandates the registration of certain data elements, ClinicalTrials. gov also includes a broad set of optional data elements.…”

mentioning

confidence: 99%

Trial Registration at ClinicalTrials.gov between May and October 2005

2005

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BACKGROUND-Clinical trial registration allows interested parties to obtain information about ongoing and completed trials, but there are few data indicating the quality of the information provided during the registration process. We used information in the publicly available ClinicalTrials.gov database to describe patterns of trial registration before and after the implementation by journal editors of a new policy requiring registration as a prerequisite for publication.

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Design and Implementation of a National Clinical Trials Registry

Cited by 80 publications

References 14 publications

Characteristics of Oncology Clinical Trials

Characteristics of Oncology Clinical Trials

Design of Genetics Home Reference: A New NLM Consumer Health Resource

Trial Registration at ClinicalTrials.gov between May and October 2005

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