Advertisement

ClinicalTrials.gov: Linking Patients to Medical Research

  • Alexa T. McCray
Part of the Health Informatics book series (HI)

Abstract

ClinicalTrials.gov is a system designed to provide patients, families, and other members of the public with easy access to Web-based information about clinical research studies. The system owes its creation to a section of the Food and Drug Administration Modernization Act (1997), which charged the National Institutes of Health (NIH) with creating such a resource. The scope of this legislation is broad, requiring publicly available information on all clinical trials—whether federally or privately funded—for experimental treatments for serious or life-threatening diseases and conditions. On behalf of all NIH Institutes, the National Library of Medicine (NLM) developed ClinicalTrials.gov and made it available to the public in February 2000.

Keywords

Acute Myeloid Leukemia Acute Myelogenous Leukemia Clinical Trial Registry Unify Medical Language System Document Type Definition 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. FDA Modernization Act of 1997, Public Law 105-115, Section 113. Information Program on Clinical Trials for Serious or Life-Threatening Diseases, http://www.fda.gov/cder/guidance/105-115.htm. Accessed 12/20/2000.Google Scholar
  2. International Collaborative Group on Clinical Trial Registries. 1993. Position Paper and Consensus Recommendations on Clinical Trial Registries. Clinical Trials Metaanalysis 28:255–266.Google Scholar
  3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1996. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice, 30–33. http://www.ifpma.org/pdfifpma/e6.pdf. Accessed 12/20/2000.Google Scholar
  4. McCray AT, Ide NC. 2000. Design and Implementation of a National Clinical Trials Registry. Journal of the American Medical Informatics Association 7(3):313–323.PubMedCrossRefGoogle Scholar
  5. McCray AT. 2000. Better Access to Information about Clinical Trials. Annals of Internal Medicine 133(8):609–614.PubMedGoogle Scholar
  6. Meinert CL. 1988. Toward Prospective Registration of Clinical Trials. Controlled Clinical Trials 9:1–5.PubMedCrossRefGoogle Scholar
  7. Spilker B. 1996. Guide to Clinical Trials. Philadelphia: Lippincott-Raven. 816–819.Google Scholar
  8. UMLS Information, http://umlsinfo.nlm.nih.gov/. Accessed 12/20/2000.Google Scholar

Copyright information

© Springer Science+Business Media New York 2002

Authors and Affiliations

  • Alexa T. McCray

There are no affiliations available

Personalised recommendations