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Research and clinical management of patients in PRD epidemics in sub-Saharan Africa

Status: Closed
Type of action: Research and Innovation Action (RIA)
Call budget: € 10M
Maximum funding: € 10M
Funding level: 100% of eligible costs
Stage 1 Open date: 7 July 2016, 17:00
Stage 1 Close date: 29 September 2016, 17:00
Stage 2 Open date: 22 December 2016, 17:00
Stage 2 Close date: 2 March 2017, 17:00
Go to EDCTPgrants

This call for proposals aims to support the establishment of a multidisciplinary consortium able to provide accelerated evidence for the optimal clinical management of patients and for guiding the public health response to any severe infectious outbreak caused by pathogens within the scope of the EDCTP programme with pandemic potential or that may cause significant damage to health and socio-economics in Africa (including antimicrobial-resistant pathogens).

Description

Background

Developing countries especially in sub-Saharan Africa have weak health systems, inadequate resources, and poor capacity to identify and respond quickly and effectively to disease outbreaks, making them very vulnerable to the devastating effects of most infectious diseases epidemics. The scale and overwhelming effects of the recent Ebola Virus Disease epidemic in West Africa clearly demonstrates the interconnectedness of poverty related and neglected diseases with the profound negative impact it had on other infectious diseases national programs. This situation is compounded by lack of preparedness capacity to conduct comprehensive and well-coordinated research in response to such disease threats. Moreover, with widespread population movement, immigration and global warming such epidemics have a global impact. There is a need to galvanise preparedness of health systems and services to conduct clinical management research of patients in severe epidemics in sub Saharan Africa.

Scope

This action aims to support the establishment of a multidisciplinary consortium able to provide accelerated evidence for the optimal clinical management of patients and for guiding the public health response to any severe infectious outbreak caused by pathogens within the scope of the EDCTP2 programme with pandemic potential or that may cause significant damage to health and socio-economics in Africa (including antimicrobial-resistant pathogens). Based on a comprehensive ‘inter-epidemic’ work programme, the consortium should for example: build a standardised methodological approach such as identification and strengthening of suitable clinical trial sites/centres; resolution of administrative, regulatory, ethical, and cultural barriers; harmonised clinical case definitions and management guidelines; pre-approval of adaptable protocols; mechanisms to rapidly exchange high quality data and samples. This work should aim at ensuring preparedness to perform coordinated large-scale multi-site clinical studies in response to an emerging threat. These clinical trials could include studies evaluating potential preventive or therapeutic interventions in a community or health-care setting; validation of diagnostic devices and observational clinical studies aimed at establishing the natural history and determinants of severity of the disease.

The consortium proposal should clearly outline the overall proposed operational plan with milestones and deliverables. Special attention should be given to plans for patient and public involvement and engagement; local personnel training as well as local partners’ active involvement; and strengthening of information management including establishment or upgrading of existing communication and data management IT infrastructure. A clear description of proposed research support programme, roles and contributions of partners involved in the consortium; and a sustainability strategy, should be provided. The action should result in standardised protocols, definitions, and strategies for the optimal clinical management of patients in any severe infectious outbreak with pandemic potential or significant risk of major damage to health and socio-economics in sub-Saharan Africa.

Expected impact

The consortium is expected to collaborate with similar initiatives at national, regional, European and international level, such as PREPARE and ISARIC ,and the EDCTP regional networks of excellence in order to contribute effectively to global preparedness and response activities, including the WHO blueprint, and ensure quick implementation of its findings into optimised clinical practices and to maximise synergy and complementarity.

The action should build the overall capacity for preparedness research to conduct comprehensive and well-coordinated research on the clinical management of patients in severe infectious outbreaks caused by emerging pathogens with pandemic potential or potential to cause significant damage to health and socio-economics in sub-Saharan Africa. This should facilitate the implementation of urgently needed research on emerging infectious epidemics which would provide evidence for a coherent, adequate and rapid public health response to emerging threats. The action should help public health authorities designing optimal prevention and clinical management strategies, particularly in pregnant women.

The action should also contribute to the coordination with relevant initiatives at a national, regional and international level, particularly within the context of the GLOPID-R (Global Research Collaboration for Infectious Diseases Preparedness and foster cross network collaboration to maximise synergy and complementarity and ensure quick implementation of its findings into optimised clinical practices.

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 are eligible to apply: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Republic of Congo, Djibouti, Equatorial Guinea, 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.

Procedure and application process

Submission and evaluation procedure

This is a two-stage application procedure. For the first stage, a letter of intent must be submitted by 29 September 2016 via EDCTPgrants. Applicants will be notified of the first-stage outcome before 22 December 2016. Successful applicants in the first stage will be invited to submit a full proposal. The indicative deadline fur submission of full proposals is 2 March 2017.

Evaluation criteria, scoring and thresholds

Following an admissibility and eligibility check, letters of intent and full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5.

Stage 1: Letters of Intent

For the evaluation of the first stage (Letters of Intent), only the criteria Excellence and Impact are evaluated. Within these criteria, only the aspects in bold will be considered. The threshold for both individual criteria will be 4. The overall threshold, applying to the sum of the two individual scores, will be set at the level such that the total requested budget of proposals admitted to stage 2 is as close as possible to three times the available budget. The actual level will therefore depend on the volume of proposals and funding request per proposal received. The threshold is expected to normally be set at 8 or 8.5. Successful applicants will be invited to submit a full proposal in the second stage.

Stage 2: Full proposals

For the evaluation of the second stage (Full Proposals), evaluation scores will be awarded for the criteria Excellence, Impact and Implementation. Each criterion is scored between 0 and 5. The threshold for individual criteria is 3 and the overall threshold for the sum of the three individual scores is 10. Applicants have the opportunity to submit a written response to the expert reviewers’ comments prior to an expert review committee meeting convened by EDCTP to finalise the funding recommendations.

The following aspects are considered under the evaluation criteria:

1. Excellence

  • Fit with the scope and objectives of the EDCTP2 programme and the call topic description.
  • Importance, relevance/pertinence and clarity of the objectives.
  • Soundness of the concept and credibility of the proposed approach/methodology.
  • Importance of the question being addressed and the rationale/need for the proposed clinical trial(s) now.
  • Excellence and appropriateness of the clinical trial design, including the proposed location(s) of the trial.
  • Extent that the proposed trial will advance the field. In particular, how it differs from or complements any relevant planned, ongoing or recently completed trials internationally.
  • Appropriate consideration of interdisciplinary approaches, and where relevant, use of stakeholder knowledge

 

2. Impact

  • The extent to which the outputs of the proposed work would contribute, at the European, African and/or International level, to each of the expected impacts listed in the work plan under the relevant topic.
  • Likelihood to result in major advances for the field.
  • Advancing the clinical development of new and improved products.
  • Generalisability of the trial/study results beyond the immediate research setting in a way that will maximise the impact of the results.
  • Contribution to improved disease management and prevention through changes in policy, with the ultimate goal of improving public health.
  • Contribution to strengthening the capacity in sub-Saharan Africa to conduct clinical trials.
  • Effectiveness and quality of the proposed measures to exploit and disseminate the project results (including management of IPR) to communicate the project activities to different target audiences, and to manage research data where relevan

 

3. Quality and efficiency of the implementation

  • Quality and effectiveness of the work plan, including extent to which the resources assigned to work packages are in line with their objectives and deliverables.
  • Appropriateness of the management structures and procedures, including risk and innovation management, and how responsibilities for research data quality and sharing, and security will be met.
  • Complementarity of the participants within the consortium, and the extent to which the consortium as whole brings together the necessary expertise.
  • Appropriateness of the allocation of tasks and resources, ensuring that all participants have a valid role and adequate resources in the project to fulfil that role.
  • Feasibility and appropriateness of the methods and project management to achieve the objectives within the timeframe of the grant.
  • Compliance with national and international standards of research, Good Clinical Practice, ethics and safety related issues.
  • Participants have the operational capacity, to carry out the proposed work, based on the competence and experience of the individual participant(s).
  • Competence of the participants and their investigators in conducting trials according to international standards of Good Clinical Practice (ICH-GCP).
  • Involvement of sub-Saharan African researchers in the scientific leadership of the clinical trial.
  • Arrangements and plans to take forward clinical development of the products under evaluation (where applicable).

 

For all applications involving human participants, and/or human tissues, cells or personal data, the evaluation process will include an assessment of ethical issues.

Financial provisions

The call budget is 10 million EUR.

The requested EDCTP contribution per project should not exceed 10 million EUR. The funding level is 100% of eligible costs.

EDCTP considers that proposals 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 of a different duration.

Grant agreement

The Coordinator is required to sign a grant agreement with EDCTP (EDCTP2 multi-beneficiary grant agreement) within three months of receipt of the conditional award letter. All participants in the action must sign a consortium agreement.

Application process

  • The application must be submitted online via EDCTPgrants
  • Only registered users of EDCTPgrants system can apply for grants and therefore you are advised to register on the system as soon as possible

Documents and more information

Documents

 

More information

 

* Updated 12 May 2017 – This page was updated to remove a clarification only relevant during the application phase.