Innovative approaches to enhance poverty-related diseases research – 2020

Description

Background
Despite large-scale investments in product development for poverty-related diseases (PRDs), progress in achieving public health gain is slow. Alongside sustained, long-term funding for product development, there is a need to encourage the use of new, innovative approaches and emerging technologies in sub-Saharan Africa, to achieve rapid progress and impact. 

Scope
The purpose of this call for proposals is to fund a number of small- to medium-scale clinical trials and/or clinical research studies that can deliver proof-of-concept or validation of smart, highly innovative technologies or concepts to prevent, treat or diagnose PRDs in sub-Saharan Africa. The call is strictly aimed at supporting novel innovations, and therefore excludes concepts and technologies that have previously been commercialised, rolled out, tested in large trials, or are already in routine use in healthcare settings. The proposed technologies must have the potential to:

• Provide pilot data to advance the testing of new technologies in future large-scale studies
• Generate results to inform the design of larger-scale studies
• Accelerate the development of new, low-cost, easy-to-implement solutions to address barriers to progress
• Strengthen research capacity of institutions to introduce and implement new technologies
• Increase collaboration with (development) partners, including increasing leverage of funding
• Contribute to creating solutions for improved development or delivery of medical interventions for vulnerable populations in low resource settings.

Proposals may address any disease or group of diseases within the scope of EDCTP2. Proposals should include one (or more) small- to medium-scale studies in sub-Saharan Africa. Proposals that combine medical and pharmaceutical technologies with other scientific areas such as mobile technologies and digital technologies (mHealth and eHealth), big data processing, and other emerging technologies are particularly encouraged, as are proposals involving small- or medium-sized enterprises. Applications must describe how the proposed research will inform future trials or implementation. The action should start no later than 1 October 2021 and must be completed before the end of 2024.

Due to the extraordinary global crisis of COVID-19 that is also affecting African countries, this topic should also be considered by applicants.

Expected impact
Projects funded under this call for proposals are expected to:

• accelerate the development of new or improved clinical interventions, or enhance the utility of existing interventions, in order to contribute towards the reduction of the burden of PRDs in sub-Saharan Africa
• contribute to the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’
• contribute to increased uptake and implementation of innovative technologies in research and clinical practice in sub-Saharan Africa.

Eligibility
A proposal/application will only be considered eligible if:

1. its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
2. it complies with the eligibility conditions for participation set out below, depending on the type of action:
   • At least three legal entities. Two of the legal entities shall be established in two different Participating States (European Partner States)* and one of the legal entities must be established in a sub-Saharan African** country. All three legal entities must 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
*The Participating States (European Partner States) are Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, and the United Kingdom.

**The following sub-Saharan African countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic People’s Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Eswatini, Ethiopia, Equatorial Guinea, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Tanzania, Togo, Uganda, Zambia, and Zimbabwe.

Procedure and application process

Submission and evaluation procedure
This is a single-stage application procedure. Proposals must be submitted by 13 August 2020, 17:00 CEST via EDCTPgrants. Evaluation results are expected to be made available by 12 January 2021.

Evaluation, scoring and thresholds
Following an admissibility and eligibility check, full proposals are evaluated by external, independent experts. Proposals are evaluated according to the criteria Excellence, Impact and Implementation (see Article 15 of the Horizon 2020 Rules for Participation Regulation No 1290/2013). Each criterion will be scored out of 5. The threshold for individual criteria will be 3. The overall threshold, applying to the sum of the three individual scores, will be 10.

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

The following aspects are considered under the evaluation criteria:

1. Excellence

• Fit with the scope and objectives of the EDCTP2 programme, the EDCTP Association strategic research agenda 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) or research study 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 and gender dimension in research and innovation content.

2. Impact

• Call-specific aspects as listed under ‘expected impact’ in each individual call.
• 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 in the field with potential benefit of the research to the affected populations.
• 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 and practice, 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.

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 this call for proposals, the Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Financial provisions
The call budget is EUR 23.4 million.
The funding level is 100% of eligible costs.

Grant agreement
Participants in actions resulting from this call for proposals will be required to conclude a consortium agreement prior to the conclusion of the General EDCTP2 grant agreement (multi-beneficiary).

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

More information

• EDCTP2 Frequently Asked Questions about calls for proposals
• For specific questions related to this call for proposals, please contact: Johanna Roth at roth@edctp.org.
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org.
• For guidance on applying to EDCTP, please refer to the Templates, guides and policies section of the EDCTP website.
• The EDCTP2 programme runs until the end of December 2024. Applicants should take into consideration the programme end date when planning their proposals.

Projects awarded under this call

CAGE-TB
Automated smartphone-based cough audio classification for rapid tuberculosis triage testing (Cough Audio triaGE for TB)

Stellenbosch University, South Africa, with partners from Germany, the Netherlands and Uganda
Project coordinator: Professor Grant Theron
Starting date: 1 July 2021
Duration: 36 months
Grant amount: EUR 2,891,456.25
Grant agreement: RIA2020I-3305

fPCV – Niger
Determining whether mass campaigns with fractional dose PCV10 would accelerate herd protection against pneumococcal transmission in sub-Saharan Africa

Epicentre, Paris, France, with partners in Kenya, Niger, and the United Kingdom 
Project coordinator: Dr Rebecca Grais
Starting date: 01 May 2021
Duration: 21 months
EDCTP grant amount: EUR 1,442,935
Grant agreement: RIA2020I-3282

GIFT
Genital InFlammation Test (GIFT) for HIV prevention and reproductive health: point-of-care cytokine biomarker lateral flow test for asymptomatic inflammatory sexually transmitted infections (STIs) and bacterial vaginosis (BV)

University of Cape Town (UCT), South Africa, with partners from Australia, France, Madagascar, the Netherlands, South Africa, United Kingdom and Zimbabwe
Project coordinator: Dr Jo-Ann Passmore
Starting date: 1 July 2021
Duration: 42 months
Grant amount: EUR 3,508,462.25
Grant agreement: RIA2020I-3297

IMPALA
An Innovative Monitoring system for PAediatrics in Low-resource settings: an Aid to save lives

Stichting Amsterdam Institute for Global Health and Development (AIGHD), the Netherlands, with partners from Malawi, the Netherlands and United Kingdom
Project coordinator: Dr Job Calis
Starting date: 1 May 2021
Duration: 42 months
Grant amount: EUR 3,439,610
Grant agreement: RIA2020I-3294

SIMBLE
Clinical diagnostic trial in Western Africa of a simplified blood culture system to improve healthcare in low-resource settings

Prins Leopold Instituut voor Tropische Geneeskunde (ITM), Belgium, with partners from Belgium, Benin, Burkina Faso, France, Malawi, the Netherlands, and Spain
Project coordinator: Dr Liselotte Hardy
Starting date: 1 July 2021
Duration: 42 months
Grant amount: EUR 4,564,621.25
Grant agreement: RIA2020I-3270
Project website

VL-INNO
Next-generation diagnostics and oral treatment for visceral leishmaniasis in Eastern Africa: transforming patient care through innovation

Drugs for Neglected Diseases innovation (DNDi), Geneva, Switzerland, with partners in Belgium, Ethiopia, Kenya, Spain, Sweden, Switzerland and the United Kingdom 
Project coordinator: Dr Fabiana Alves (DNDi)
Starting date: 01 October 2021
Duration: 39 months
EDCTP grant amount: EUR 4,970,462
Grant agreement: RIA2020I-3290