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

Open Access Methodological considerations in clinical trials for new MDR-TB treatment regimens

Download Article:
 Download
(PDF 58.5 kb)
 
In contrast to the treatment of drug-susceptible tuberculosis (TB), the evidence base underpinning global guidelines for the treatment of multidrug-resistant (MDR) TB is very poor. This, combined with the lack of experience from previous trials and the nature of the disease, means that a number of methodological aspects are specific only to trials for new MDR-TB regimens. These aspects include the weight of evidence required to change policy and practice, the flexibility to make adaptations to an ongoing trial, the choice of patient population, the importance of internal control, the duration and frequency of follow-up, and safety monitoring of novel combinations of new and repurposed drugs.
No Reference information available - sign in for access.
No Supplementary Data.
No Article Media
No Metrics

Keywords: MDR-TB; clinical trials; evidence-based medicine; methodology

Document Type: Research Article

Affiliations: Medical Research Council Clinical Trials Unit, University College London, London, UK

Publication date: December 1, 2016

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 tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They 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