Wednesday, 04 March 2009 03:30 Written by
Published in Tuberculosis

Regional meeting for the development of Tuberculosis Clinical Research March 2009

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Three main objectives:

- Addressing the key issues and activities that need to be conducted in the Republic of Congo, Cameroon and Gabon to provide additional capacity trough the development of human resources in the skills required to conduct future Tuberculosis clinical Phase I, II and III trials in compliance with ICH/GCP standards

- Audit the health system in place (hospital and laboratories working with CANTAM) engaged in the fight against Tuberculosis

- Meet local ethical review boards in order to understand their interactions with institutions involved in Medical Research

Recommendations:

Developing sites need to collect baseline data through epidemiological and demographic surveys aiming at the establishment of a cohort. This includes information on:

  1. The prevalence of Tuberculosis in the population
  2. The institutions involved in the diagnosis and treatment of Tuberculosis
  3. Proportion of treatment failure
  4. Prevalence of resistant strains and type of resistance
  5. PFollow up of patients and determination of the proportion of loss to follow-up in the cohort study

It is important:

  1. To recruit an Epidemiologist and Biostatistician for the design clinical studies on Tuberculosis.
  2. The institutions involved in the diagnosis and treatment of TuberculTo establish basic diagnostic laboratories and train technicians and researchers able to conduct clinical trial on Tuberculosis under GCP/GLP guidelines. These sandwich training programs and participation in ongoing clinical trials in Africa (South Africa, Gambia and Gabon) will allow acquisition of competences trough learning by doingosis
  3. To carry out site assessment of TB sites.

Other types of baseline studies considered includes:

  1. To recruit an Epidemiologist and Biostatistician for the design clinical studies on Tuberculosis.
  2. Immune response studies
  3. Follow-up of exposed and infected population
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