Indepth Effectiveness ans Safety Studies INESS

of Antimalaria in Africa

  • A standardised process for evaluating the real life safety and effectiveness of current and alternative ant malarial treatments will be developed and implemented.
  • During the initial phase of INESS, the current first-line ACTs in Ghana and Tanzania will be evaluated. This will provide information on their safety and effectiveness, which is still unavailable despite their large scale utilisation.
  • Once a new anti-malarial is registered in a participating country, it will be introduced through the routine public health services in the districts hosting the selected INDEPTH DSS sites. New drugs will be evaluated using standardised systems to generate effectiveness and safety assessments which are comparable to those for currently recommended drugs … (full long text Research Sites).

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About the INESS project: What is INESS and what is new?

The INDEPTH Effectiveness and Safety Studies of Anti-malarial Drugs in Africa (INESS) is an exciting new platform that aims to enable African researchers to carry out a large Phase IV trials. This will result into systematic, evidence-based reviews of the comparative effectiveness and safety of malaria drugs in many widely used drug classes, and to apply the findings to inform public policy and related activities in local settings.

This kind of Phase IV studies for antimalarials has not previously taken place in Africa under the direction of African researchers. It will provide objective country-specific effectiveness and safety data to inform global and national policy and practice and will speed up access to evidence on treatment effectiveness and safety. INESS will also enhance African capacity to monitor local health systems in order to track the costs, effectiveness of coverage, and impact of newly registered antimalarial treatments. Overall, INESS aims to reduce the time gap between the licensing of a new drug and its introduction into health systems for use.

INESS goals and objectives:

The INESS platform aims to provide national, regional and international health decision makers with independent and objective evidence on the safety and effectiveness of new antimalarial drugs as a basis for malaria treatment policy in Africa.

INESS seeks to enable decision making and not to make decisions on behalf of affected countries. The more particular objectives of INESS are to:

  • develop and maintain a Phase IV effectiveness and safety studies platform in Africa;
  • assess the effectiveness and safety of new malaria treatments – and the factors that determine effectiveness and safety – in real life settings in Africa; and
  • undertake research in line with comprehensive pharmaco-vigilance in the context of African health systems.

How and where is INESS being implemented?

  • A standardised process for evaluating the real life safety and effectiveness of current and alternative antimalarial treatments will be developed and implemented.
  • During the initial phase of INESS, the current first-line artemisinin-based combination therapy (ACT) in Ghana and Tanzania will be evaluated. This will provide information on their safety and effectiveness, which is still unavailable despite their large scale utilisation.
  • Once a new anti-malarial drug is registered in a participating country, it will be introduced through the routine public health services in the districts hosting the selected INDEPTH Health and Demographic Surveillance System (HDSS) sites. New drugs will be evaluated using standardised systems to generate effectiveness and safety assessments which are comparable to those for currently recommended drugs.
  • INESS will be undertaken at eight sites in four sub-Saharan countries – including some of the world’s most severely malaria-affected communities. The four-year INESS project takes place in eight INDEPTH HDSS sites in Burkina Faso, Ghana, Mozambique and Tanzania.
  • The extensive geographic reach of the project provides an opportunity to evaluate antimalarial drugs over a wide range of epidemiological and health system settings. The INDEPTH HDSS sites have functioned for many years as health and demographic observatories. INESS studies target a population of more than 2 million participants.

INESS will consist of three key project components: … (full long text about the INESS project).

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