Strategic action for overcoming drug resistance in malaria – 2018

Description

Background
There is a need to develop safe and effective drugs that can be used to progress the malaria elimination agenda, and with a particular emphasis on pregnant women, infants and children. Current treatment of malaria is highly dependent on artemisinin-based combination therapies (ACT), but emerging resistance has highlighted the need to develop a broader portfolio of antimalarial drugs, including new or repurposed non-ACT drugs for chemoprevention and treatment as well as long-acting products with transmission blocking potential. Clinical trials to support the product approval process for new drugs are often large in scale, complex and prohibitively expensive for a single funder. Coordination and collaboration between partners and funders is therefore essential to leverage sufficient expertise, resources and investments for accelerating the development of new or improved products and maximise the impact of research investments.

Scope

The purpose of this Call for Proposals is to support one large-scale strategic action (clinical research activities) that is part of a bigger portfolio of clinical trials with the capacity to develop new and diverse antimalarial drugs against Plasmodium falciparum and/or Plasmodium vivax, including combination therapies that may be used for treatment or chemoprevention of malaria in sub-Saharan Africa. The proposed action shall evaluate and compare novel drug candidates or drug combinations, develop criteria for early selection/deselection of candidates and speed up drug development through innovative trial designs that allow for a reduction in subject numbers and rapid generation of conclusive results. Proposals should present an attractive R&D portfolio and include one or more clinical trials (phase I to III) with appropriate consideration of relevant target populations, including pregnant women, infants and children. The proposed study(ies) should be conducted in sub-Saharan Africa but may form part of a larger trial that is conducted globally.The clinical trial(s) must be supported by an appropriate regulatory approval and access strategy and/or include plans for uptake into policy and practice at national or international level. The proposed clinical trial(s) must be conducted to International Council on Harmonisation – Good Clinical Practice (ICH-GCP) regulatory and ethical standards. Furthermore, the proposal must clearly document the consortium’s proven capacity to bring a medicinal product to market.

Proposals for a strategic action must also present the broader description of the portfolio of clinical trials/studies in their entirety, including details of the trial(s) for which EDCTP funding is requested and the component(s) that are to be financed from other sources. Proposals should make a clear distinction between the broader context of the portfolio of studies as opposed to the proposed action itself (i.e. the specific clinical trials or part of trial to be funded as a strategic action by the EDCTP Association). The portfolio must be of a sufficient scale and ambition to justify EDCTP support in combination with financial support from other funders, such as EDCTP2 Participating States and/or third parties.

The maximum amount requested from the EDCTP Association shall not exceed EUR 22 million to be matched by an equal or greater financial contribution from other funders.  EDCTP considers that proposals with a total cost of between EUR 25 and 50 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

EDCTP considers that proposals for a large-scale strategic action of between 48 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

The action funded under this Call for Proposals should contribute to increased international cooperation among researchers and funders, catalyse research synergies, and leverage resources and investments in order to achieve rapid advances in the development of new or improved anti-malarial drugs or drug combinations. Proposals that leverage major relevant financial contributions from funders other than the EDCTP Association will be considered to have a higher impact.

The action should have the potential to achieve maximum impact in the field and to make a significant contribution to the objectives of the EDCTP2 programme, and in particular:

• contribute towards combatting drug resistance through development of new or improved antimalarial products
• lead to the advancement of new drugs and/or drug combinations, with the aim of registration of new drug(s) and/or drug combinations for treatment and prevention of malaria in sub-Saharan Africa and globally
• contribute to the reduction of malaria mortality and morbidity in sub-Saharan Africa, particularly in pregnant women, infants and children and thus contribute to achieving SDG 3 ‘Ensure healthy lives and promote well-being for all at all ages’.

Eligibility
A proposal/application will only be 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 set out below, depending on the type of action:
   • Consortia comprising a minimum of three independent legal entities are eligible to apply. 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 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

* Europe
The following European countries are EDCTP Participating States: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and United Kingdom.

** Sub-Saharan Africa
The following African countries are eligible: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, 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, Swaziland, Tanzania, Togo, Uganda, Zambia, Zimbabwe.

Procedure and application process

Submission and evaluation procedure
This is a single-stage application procedure. Proposals must be submitted by 30 October 2018, 17:00 CET via EDCTPgrants. Evaluation results are expected to be made available by 14 March 2019.

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. Each criterion is scored between 0 and 5.

The following aspects are considered under the evaluation criteria:

1. Excellence

• Fit with the scope and objectives of the EDCTP2 Programme, the EDCTP 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.

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
• 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

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 time frame 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).

The Coordinator has a ‘right to reply’ to the expert assessments (rebuttal procedure).

Financial provisions

The call budget is EUR 22 million.

The requested EDCTP contribution per project should not exceed EUR 22 million.
The funding level is 100% of eligible costs.

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 evaluation outcome letter. All participants in the action must sign a consortium agreement prior to signature of the grant 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 & info

Documents

• Template of application form – Full Application (Word)
• Template for essential information to be provided for proposals including clinical studies (Word)
• Guidance for applicants on preparing full proposals and annex 1 of the grant agreement (PDF)
• Call-specific FAQs (PDF)

More information

• For questions related to this call for proposals, please contact: Dr Montserrat Blazquez-Domingo at blazquez@edctp.org
• For questions and issues about EDCTPgrants and the online application submission please contact EDCTP via edctpgrants@edctp.org
• For guidance on online application procedure, please refer to the Guidance for applicants
• For more information about EDCTP2 procedures, please refer to the EDCTP2 Grants Manual and EDCTP2 FAQs.
• EDCTP2 policy on clinical trials registration, publication and data sharing (PDF)
• Global Code of Conduct for Research in Resource-Poor Settings (PDF)

Projects awarded under this call

PAMAFRICA
Portfolio approach to developing the next generation of malaria treatments for Africa

Medicines for Malaria Venture (MMV) Cointrin, Switzerland, with partners in Burkina Faso, Gabon, Germany, Mozambique, Spain, Switzerland, and Uganda.
Project coordinator: Dr Tim Wells (MMV)
Starting date: 01 January 2020
Duration: 60 months
EDCTP grant amount: EUR 21,990,938
Grant agreement: RIA2018SD-2306
Project website