Skip to main content
padlock icon - secure page this page is secure

Free Content Compassionate use of and expanded access to new drugs for drug-resistant tuberculosis [Review article]

Download Article:
 Download
(PDF 285.7 kb)
 
Several new classes of anti-tuberculosis agents are likely to become available in the coming decade. Ensuring prompt access to these drugs for patients without other treatment options is an important medical and public health issue. This article reviews the current state of ‘compassionate use’ and ‘expanded access’ programs for these new drugs, and identifies several shortcomings that will limit patient access to the drugs. A series of five steps is outlined that will need to be taken by national health bodies, international agencies and non-governmental organizations to prevent undue delays in access to new tuberculosis drugs for patients who could benefit from them. Following these steps can ensure that patients will be able to benefit from access to these drugs, while minimizing the risk of emergence of resistance to the drug.
No Reference information available - sign in for access.
No Supplementary Data.
No Article Media
No Metrics

Keywords: expanded access program; import waiver; open enrollment trial; pre-approval access; pre-marketing access

Document Type: Research Article

Affiliations: 1: Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts, USA 2: Tibotec, Turnhout, Belgium 3: Stop TB Department, World Health Organization, Geneva, Switzerland 4: PATH, Washington DC, USA 5: Medical Service Corporation International, Arlington, Virginia, USA 6: HIV/TB Division, Bill & Melinda Gates Foundation, Seattle, Washington, USA 7: Partners in Health, Boston, Massachusetts, USA 8: Médecins Sans Frontières, Paris, France

Publication date: February 1, 2013

More about this publication?
  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on lung health world-wide.

    To share scientific research of immediate concern as rapidly as possible, The Union is fast-tracking the publication of certain articles from the IJTLD and publishing them on The Union website, prior to their publication in the Journal. Read fast-track articles.

    Certain IJTLD articles are also selected for translation into French, Spanish, Chinese or Russian. These are available on the Union website.

  • Editorial Board
  • Information for Authors
  • Subscribe to this Title
  • International Journal of Tuberculosis and Lung Disease
  • Public Health Action
  • Ingenta Connect is not responsible for the content or availability of external websites
  • Access Key
  • Free content
  • Partial Free content
  • New content
  • Open access content
  • Partial Open access content
  • Subscribed content
  • Partial Subscribed content
  • Free trial content
Cookie Policy
X
Cookie Policy
Ingenta Connect website makes use of cookies so as to keep track of data that you have filled in. I am Happy with this Find out more