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Clinical trials to reduce health inequities in pregnant women, newborns and children

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Clinical trials to reduce health inequities in pregnant women, newborns and children

Status:Active
Type of action:Research and Innovation Action (RIA)
Call budget:€38.23 M
Funding level:Up to 100% of eligible costs
Stage 1 Open date: 4 July 2017, 17:00
Stage 1 Close date: 13 October 2017, 17:00
Stage 2 Open date: 22 December 2017, 17:00
Stage 2 Close date: 14 March 2018, 17:00

Go to EDCTPgrants

Expected number of grants: 5-10
Call identifier: RIA2017MC

Description

Background

Poverty-related diseases (PRDs) remain the leading causes of morbidity and mortality in sub-Saharan Africa, especially during pregnancy and childhood. Despite progress in other age groups, effective treatment and prevention of PRDs in mothers, newborns and children is often lacking and/or lagging. The frequent exclusion of pregnant women and children from clinical trials and the paucity of available products that target these groups are factors that contribute to these populations having the lowest health indicators. Additional challenges relate to the limited financial incentives associated with the adaption of off-patent medicines to the specific needs of pregnant women and paediatric populations. Therefore, concerted efforts are needed to increase access to potentially life-saving, cost-effective interventions to prevent and treat PRDs in pregnant women, newborns and children and to enhance use of existing interventions in these populations.

Scope

The objective of this call is to accelerate the adaption and/or optimisation of treatment and prevention products (excluding vaccines) for PRDs in sub-Saharan Africa for use in pregnant women, newborns and/or children. This call is restricted to the following diseases: HIV, malaria, tuberculosis, diarrhoeal diseases and lower respiratory infections. Proposals that are in line with the priorities of EDCTP’s strategic research agenda are encouraged.

Proposals should focus on adaption of existing medicines, including off-patent products, to the specific needs of pregnant women, newborns and/or children. Proposals should typically include one (or more) clinical trials conducted in sub-Saharan Africa to assess the pharmacokinetics, efficacy and safety, and/or the development of age-appropriate formulations. However, other trial methodologies and study designs may be considered where the methodology is justified in the proposal as being the most appropriate to provide robust evidence. Projects must assure that the clinical trials are appropriately conducted, respecting current legislation and considering the ethical aspects and particular needs of the study subjects and their families.

The proposal must include full details of the product development milestones including specific go/no-go criteria for the proposed clinical trial(s) as well as specific plans for the subsequent regulatory approval process; for trials involving children, this is ideally a paediatric investigation plan, which should aim at obtaining a relevant market authorisation, such as the Paediatric Use Marketing Authorisation (PUMA).

EDCTP considers that proposals for activities of between 36 and 60 months duration would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals for activities of a different duration.

Expected impact

Projects are expected to contribute to expanding the availability of medicines for PRDs for pregnant women, newborns and children in sub-Saharan Africa. Projects should provide evidence for better use of medicinal products in pregnant women and/or paediatric populations, and the acquired knowledge should be used towards obtaining a relevant market authorisation such as the Paediatric Use Marketing Authorisation (PUMA) for products for newborns and children or an equivalent for products for pregnant women.

Eligibility

Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities must be established in two different European Participating States(1) of the EDCTP Association and one of the legal entities must be established in a sub-Saharan African country(2). All three legal entities shall be independent of each other.

‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.

Notes:

  1. Legal entities in the following European countries: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.
  2. Legal entities in the following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Djibouti, Eritrea, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé & Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Sudan, South Africa, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia and Zimbabwe.

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