Infectious Disease Clinical Trial Development Award is sponsored by Wellcome. This award supports the formation of transdisciplinary teams led from Africa, South Asia, or South-East Asia to develop innovative ideas for future late-stage clinical trials.

While the focus is on infectious disease, the development of robust research frameworks and capacity in emerging markets can indirectly support broader research capabilities relevant to impact investing.

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We fund research around the world, across a broad range of disciplines, to understand life, health and wellbeing and to deliver equitable health solutions. Research funding overview * Find a funding opportunity * Funding policies and grant conditions * Login to Wellcome Funding We work with communities, governments and partners across the world to advocate for evidence-based health policies that support the communities most affected.

Engagement and advocacy overview * Wellcome Global Monitor * Advocacy and partnerships We're bringing together expertise from across science, innovation and society to generate new knowledge and find equitable solutions to improve life, health and wellbeing. Read our insights to learn more about our activities and impact supporting our mission. We are a charitable foundation with a vision of a healthier future for everyone.

# Infectious Disease Clinical Trial Development Award This funding call will support the formation of transdisciplinary teams led from Africa, South Asia or South-East Asia to develop an innovative idea for a future proposal for a clinical trial that optimises licensed infectious disease interventions to drive impact in low- and middle-income countries. * Is your organisation right for this call? * Is your research right for this call?

* How applications are assessed * Research costs we will cover * Eligible countries for your administering organisation Lead applicant career stage: Mid-career researcher, Established researcher Administering organisation location: Low- or middle-income country in Africa, South Asia or South-East Asia (apart from mainland China) We hope to make around 20 awards in this highly competitive funding call.

This funding call is delivered in partnership with the Foreign, Commonwealth and Development Office (FCDO). If you have a team and a clinical trial proposal ready, you can apply to our Infectious Disease Clinical Trial Award: Optimising interventions for impact.

The pharmaceutical intervention (vaccine or therapeutic) must focus on one of the following disease areas: * mycobacterial infections (tuberculosis, leprosy or infections with non-tuberculous mycobacteria) * bacterial infections (sexually transmitted infections, lower respiratory tract infections or bloodstream infections) * invasive fungal infections * dengue, leishmaniasis or schistosomiasis ## Upcoming application stage Calculating next key date… Application process timeline You can apply to this call if you are a team of at least two applicants developing an innovative clinical trial idea, and if your team: * Has a lead applicant and at least one coapplicant based at an organisation in Africa, South Asia or South-East Asia, both of whom intend to remain resident in that country for the duration of the award.

See a full list of countries that are eligible to apply. * Is an appropriate size for the proposed project. Teams must not exceed eight applicants (lead applicant and seven coapplicants).

There is no limit on the number of collaborators. * Has at least 50 percent of applicants based in Africa, South Asia or South-East Asia. Teams may include coapplicants based at eligible organisations in other parts of the world.

* have the expertise and experience to design, plan and conduct clinical trials of infectious disease interventions * include or plan to include the scientific and analytical skills to manage, interpret and analyse trial data, and to generate evidence that could inform policy, practice or guidelines * have experience of building partnerships and networks * have a clear plan for using this award to develop a fully transdisciplinary team that actively fosters a diverse, inclusive and supportive research environment * Be a mid-career or established researcher.

If the lead applicant is a mid-career researcher, we strongly encourage including an established researcher as a coapplicant to provide intellectual, personal and career development support and mentorship. * Be based at an organisation in Africa, South Asia or South-East Asia (except mainland China)and intend to remain resident in that country for the duration of the award.

* Have the experience needed to design, plan and conduct clinical trials. * Have the scientific and analytical skills to manage, interpret and analyse trial data. * Have the experience needed to lead a collaborative, large scale research project and the necessary support structures in place.

* Only be a lead applicant on one application for this funding call. They may be a coapplicant on one additional application. The applications should be for different projects.

If both projects receive funding, the applicant must be able to demonstrate that they can dedicate enough time and resources to both projects. * Have a permanent, open-ended or long-term rolling contract, or the guarantee of one, for the duration of the award. The contract should not be conditional on receiving this award.

Lead applicants with less than three years remaining on their contract at the point of application must have secured their next position at an eligible organisation and provide a letter of support from that organisation. * Have a salary paid by their host organisation for the duration of the award.

Applicants who are based in a low- or middle-income country can ask for a contribution to their salary if they hold a permanent, open-ended or long-term rolling contract and rely on external grant funding for their salary. * Actively promote a diverse, inclusive and supportive environment within their team and across their organisation. * Can be based anywhere in the world except mainland China.

We expect at least 50 percent of coapplicants to be based at organisations in Africa, South Asia or South-East Asia, with the intention to remain resident in that country for the duration of the award. * Can be based at the same or different organisations as other applicants, including in different countries.

* Can be at any career stage and come from any relevant discipline, such as epidemiology and surveillance, statistics and trial methodology, health economics, implementation research, community engagement, social science, data management or policy/public health communication.

* Must be essential for the delivery of the project and make a significant contribution, for example designing an aspect of the research, writing the application, leading on a specific work package or aim, or being responsible for research or policy uptake. * Can be involved on a maximum of two applications for this funding call. The applications should be for different projects.

If both projects receive funding, the coapplicant must be able to demonstrate that they can dedicate enough time and resources to both projects. * Do not need to have a permanent, open-ended or long-term rolling contract. * Can be based at a commercial organisation.

Collaborators are distinct from coapplicants. Collaborators support the delivery of the project but don't lead on a specific component of the research. For example, collaborators could support by: * Providing access to tools or resources such as datasets or clinical records.

* Providing access to organisations led by or working in collaboration with lived experience experts. * Providing expertise on working in different countries. * Sharing subject-specific knowledge and guidance.

For example, collaborators could support by sharing expertise on statistical analysis or measurement of specific variables. Collaborators do not have to meet eligibility requirements, and they are not required to give a minimum research time commitment. Collaborators cannot receive a salary or compensation for the time spent on the proposed project.

You can request costs to cover their expenses, for example for their grant-related travel and the costs associated with providing the agreed input into the research, including the materials and consumables involved. These should be costs directly related to the research.

### If you’ve spent time away from research You can apply for this award if you have spent time away from research (for example, for a career break, parental leave or long-term sick leave). We will take this into consideration during the review of your application. Lead and coapplicants can be working part-time.

Their part-time work should be compatible with delivering the project successfully.

You should not apply for this call if: * you intend to carry out activities which involve the transfer of funds into mainland China * you are a lead applicant based at an organisation outside of Africa, South Asia or South-East Asia * you are an individual without at least one coapplicant * you are a lead applicant based at a commercial organisation * you cannot demonstrate the ability to dedicate enough time and resources to the project, if funded * you are a lead applicant on another application for this award * you are listed as a coapplicant on more than two applications for this award * you are a lead applicant on an application for our Infectious Diseases Clinical Trial Award: Optimising interventions for impact * your proposal cannot be scaled up into a late-stage randomised controlled trial * your proposal does not focus on one of the disease areas specified in the list below: * mycobacterial infections (tuberculosis, leprosy or infections with non-tuberculous mycobacteria) * bacterial infections (sexually transmitted infections, lower respiratory tract infections or bloodstream infections) * invasive fungal infections * dengue, leishmaniasis or schistosomiasis ## Is your organisation right for this call?

The administering organisation is where the lead applicant is based. It is the organisation responsible for submitting your final application to Wellcome and managing the finances of the grant if it is awarded. ### Where your administering organisation is based The administering organisation must be based in Africa, South Asia or South-East Asia, apart from mainland China.

See a full list of countries that are eligible to apply. The administering organisation can be a: * higher education institution * healthcare organisation * not-for-profit or non-governmental research organisation This funding call is open to Wellcome’s major international programme partnerships in Africa and Asia (KWTRP, AHRI, MLW, MORU and OUCRU).

Commercial organisations are not eligible to apply as administering organisations for this call. However, coapplicants and collaborators can be based at commercial organisations.

### Collaboration agreements If the application involves a collaboration or partnership between multiple organisations, the partners must enter into a suitable collaboration agreement, including provisions that cover: * division of grant activities between the parties * management and distribution of the grant funding * access to background intellectual property * ownership of foreground intellectual property * arrangements for the protection, management and exploitation of foreground intellectual property The lead applicant’s administering organisation is required under our grant conditions to own all the foreground intellectual property arising from the project and to take the lead in any commercialisation activity.

For guidance, read Wellcome’s intellectual property policy. ### Your research environment Wellcome believes that a diversity of people and expertise leads to richer understanding and more impactful discoveries. Excellent research happens in environments where people from all backgrounds are treated with respect and are supported and enabled to thrive.

Our definition of a research environment is not limited to the quality of the infrastructure but also considers the culture and behaviours that create excellent research practice. This includes research that is inclusive in design and practice, ethical and engaged with relevant community stakeholders, as well as open and transparent. Read guidance on how to talk about research environment in your application.

## Is your research right for this call? Wellcome’s Infectious Disease strategy focuses on minimising the impact of infectious diseases on the most affected communities. Whilst new vaccines and treatments may have regulatory approval, their full impact is often limited by a lack of data on their optimal use, including the target population, dosage, range of indications, combinations and evaluation in real-world settings.

This can result in interventions failing to be adopted into guidelines or by policy makers. We want to support randomised controlled trials that optimise licensed pharmaceutical interventions to generate evidence that will result in changes to policy, practice or guidelines and lead to near-term impact in communities most affected by infectious disease.

If you already have a team in place and a clinical trial proposal ready, you can apply to our Infectious Disease Clinical Trial Award: Optimising interventions for impact. However, we recognise that some applicants may be at an earlier stage in developing their idea or assembling a team.

**This funding call will support applicants to develop an innovative idea into a fully detailed research proposal for a future randomised controlled trial and to build the transdisciplinary team needed to deliver it.

**The application must demonstrate consideration of how the clinical trial would achieve near-term impact by generating evidence to change policy, practice or guidelines for the primary benefit of low- and middle-income countries. ### What your research proposal must include Your research proposal must include: 1.

**The intervention and disease area of focus** * The pharmaceutical intervention (vaccine or therapeutic) should focus on one of the following disease areas: * mycobacterial infections (tuberculosis, leprosy or infections with non-tuberculous mycobacteria) * bacterial infections (sexually transmitted infections, lower respiratory tract infections or bloodstream infections) * invasive fungal infections * dengue, leishmaniasis or schistosomiasis **2.

A detailed plan of work** * An overview of the importance and relevance of the topic, the current evidence base, which policy, practice or guideline it is seeking to change and how a clinical trial will generate the required evidence for that change. * An overview of the work that has already been conducted and what early data or partnerships exist.

* A clear outline of the work that needs to be conducted in preparation for a clinical trial, including risks and mitigations.

This could include, but is not limited to: * the collection of epidemiological data * developing and designing a trial protocol * the generation of pilot data * the development of expertise necessary to conduct a future clinical trial * A description of how you will use the award period to build a fully transdisciplinary team that can lead a feasible randomised controlled trial proposal.

This should include how you will identify and engage relevant public health stakeholders and policymakers (those who can influence decisions on the introduction of potential interventions), and how you will involve communities most affected through engagement with community leaders, civil society and community organisations. * A description of how you will embedengaged research approachesand a commitment to collaborative working.

This should include how community and stakeholder perspectives will shape the research questions, methods and plans for testing in a clinical trial format.

* A description of your approach to data management, integration and/or sharing of the different data types, especially where data types vary from traditional epidemiological, clinical and immunological data – for example, socio-economic statistics, qualitative data, interactional/relational data and survey data. You must include how you plan to share data with relevant stakeholders.

* A description of the potential impact that this award will have on building your team, generating and collecting any preliminary data, conducting any training requirements or strengthening capacity to meet the requirements set out in theWHO guidance for best practices for clinical trials. * Applications should demonstrate how they will build capacity and experience in the specified locations.

* A Gantt chart and justification for the timeline for the proposed work. ### What your research proposal must not include Research that isn't right for this call: * Phase 1, Phase 2, Phase 3 product development, post-marketing or post-registration clinical trials. Applications for a randomised controlled trial should be submitted to our Infectious Disease Clinical Trial Award: Optimising interventions for impact.

* Controlled human infection, observational, modelling, implementation research or community engagement studies. * Studies on non-pharmaceutical interventions.

* Studies that do not focus on at least one of the following disease areas: * mycobacterial infections (tuberculosis, leprosy or infections with non-tuberculous mycobacteria) * bacterial infections (sexually transmitted infections, lower respiratory tract infections or bloodstream infections) * invasive fungal infections * dengue, leishmaniasis or schistosomiasis * Proposals exclusively being addressed by researchers based in institutions in a high-income setting or in Latin America and the Caribbean.

* Proposals that do not consider how to engage public health stakeholders and policymakers, and communities most affected by infectious disease. * Proposals that include activities which involve the transfer of grant funds into mainland China. ## How applications are assessed Applications will be assessed by an internal committee that will review eligible and in-scope proposals and make funding recommendations to Wellcome.

### Essential criteria and weightings **The research proposal (50% weighting)** * Strong justification for: * pharmaceutical intervention (vaccine or therapeutic) including current existing evidence * proposed policy, practice or guideline that you are hoping to change * location(s) where the research is to be conducted * Clear description of the proposed plan of work and key deliverables with appropriate and justified timelines.

* Clearly identified risks and mitigation. * Clear outline of the potential impact that a development award would have.

**The team’s skills and experience (25% weighting)** * the experience needed to design, plan and conduct clinical trials * the scientific and analytical skills to manage, interpret and analyse trial data * the experience needed to lead and manage a collaborative, large scale research project * experience building teams, partnerships or networks * Includes or plans to include the necessary expertise, skills and experience to deliver the proposed work in disease-affected settings.

* Has appropriate management plans in place including a clear description of how the team will work collaboratively together to deliver the proposed research. * Has strong evidence of a commitment to equity, diversity and inclusion. For example, your approach to recruiting a diverse team and how you will promote inclusion of members in the research and outputs.

**Engagement with stakeholders (25% weighting)** * A clear description of your plans for engagement activities with relevant stakeholders (public health stakeholders and policymakers, other researchers and communities most affected), how this will support the proposed research, and an appropriate budget allocation.

* A clear description of the team’s approach to equitable partnerships and how it is responsive to the needs and interests of the populations that the project is intended to serve. ## Research costs we will cover You must contribute at least 10% of your research time to the award in order to claim a contribution to your salary.

##### Lead applicants based outside of the UK or Republic of Ireland You can ask for a contribution to your salary if you work for a: * higher education institute * healthcare organisation * non-governmental organisation If you work for a higher education institute, research institute, or healthcare organisation, we will only pay your salary if you hold a permanent, open-ended or long-term rolling contract that states that you must get your salary from external grant funding.

Your administering organisation must confirm: * that you must get salary recovery from external grant funding * they will guarantee to provide salary support, including any salary not covered by Wellcome, if you cannot get it from other sources for the period of time that you will be working on the grant In all cases, the amount we pay will be proportionate to the time you contribute to the award.

For example, if you contribute 30% of your time to the award we will fund 30% of your salary. Coapplicants must contribute at least 10% of their research time to the award in order to claim a contribution to their salary. ##### Coapplicants employed by higher education institutes, research institutes or healthcare organisations 1.

###### Coapplicants with permanent, open-ended or long-term rolling contracts Coapplicants with these contract types can ask for a contribution to their salary if their employment contract states that they must get their salary from external grant funding. The amount we pay will be proportionate to the time they contribute to the award, for example if they contribute 30% of their time to the award we will fund 30% of their salary.

The coapplicant’s employing organisation must confirm: * that they must get salary recovery from external grant funding * they will guarantee to provide salary support, including any salary costs not covered by Wellcome, for the period of time that the person will be working on the grant 2.

###### Coapplicants who don’t have permanent, open ended or long-term rolling contracts Coapplicants without a permanent, open ended or long-term rolling contract can request salary depending on the amount of their time they will spend on the grant: * Less than 80% of coapplicant’s time on the grant: they can request salary proportionate to the time they will spend on the grant (minimum 10% research time).

Their organisation must guarantee space and salary support if they cannot get it from other sources for the period of time they are working on the grant. Their post cannot be dependent on the application being successful. * 80% or more of coapplicant’s time on the grant: they can ask for their full salary.

Their organisation does not have to guarantee salary support if salary cannot be obtained from other sources for the period of time they are working on the grant. The post can be dependent on the application being successful.

* If the coapplicants are employed on the award as research assistants and they are to spend 100% of their time on the award, their post does not need to be underwritten by the administering organisation and can be dependent on the application being successful. Alternatively, coapplicants may get their salary through employment on another grant.

##### Coapplicants employed by charities, social enterprises, non-governmental organisations or commercial organisations Coapplicants can ask for salary if they are employed by these organisations. Coapplicants must contribute at least 10% of their research time to the award. The amount we pay will be proportionate to the time they will contribute to the award.

Their employment contract does not need to state that they must get their salary from external grant funding. #### Staff working on your programme We will cover the salary costs of all staff, full or part-time, who will work on your grant.

Staff members may include: * research assistants or technicians employed on your grant * experts with lived experience * specialist service staff and technical experts, for example in environmental sustainability, data analysis, fieldwork and clinical studies * project manager, if you have multiple applicants on your programme * support if you or a member of staff employed on your grant is disabled or has a long-term health condition Humanities and social science researchers can ask for funds for research or teaching replacement to cover the cost of a temporary replacement lecturer.

They must retain at least a 10% commitment to teaching.

* can cover up to 33% FTE of your contracted time * are usually for a person at a more junior level than the postholder * can be spread across the full period of the grant Researchers who already get buyout costs from another grant (funded by Wellcome or elsewhere) can ask us for this cost, but only for the period of time on the award when they won't receive buyout costs from another grant.

Researchers must provide a letter from their employing organisation, confirming that their contract includes a teaching commitment. They should include this in the grant application. **PhD/Research Masters fees** We do not provide studentships on this award.

But if applicants employ research staff, including technicians, on the grant they can ask for the costs to cover their PhD/Research Masters fees. Each applicant can ask for fees for up to two research staff in total on the grant, to a maximum of eight per team. Research staff should be hired to undertake specific research activities on the grant and we will cover the fees for their PhD/Research Masters studies.

Early-career applicants (up to and including holders of early-career fellowships) may not supervise a PhD student alone but can be a co-supervisor with a mid-career or established colleague. If fees are not requested at the application stage, grant funds cannot be repurposed for them during the award. Research staff should be defined as staff members and incur a lower fee than the student rate.

Where organisations do not have a staff rate, they may request fees at the home student rate. If no other rate is available, they may request the international student rate. #### How to cost salaries for research staff Show Staff salaries should be appropriate to skills, responsibilities and expertise.

Organisations should use their salary scales to calculate these costs, which should include: * employer’s contributions, including any statutory obligations (for example, National Insurance contributions if you’re based in the UK) and pension scheme costs * Apprentice Levy charges for UK-based salaries * any incremental progression up the salary scale * locally recognised allowances such as London allowance You should allow for salary pay awards during Year 1.

If the pay award is not yet known, applicants should use the International Monetary Fund inflation rate, selecting the ‘inflation, average consumer price’ option as indicator. From Year 2 onwards, you should use your organisation’s current pay rates. We’ll provide a separate inflation allowance for salary inflation costs.

Read about the responsibilities of grantholders and organisations we fund. #### Visa and work permit costs Show If you have named people on your grant whose salaries will be funded by Wellcome, you can ask for visa or work permit costs to help them take up their posts at the host organisation.

You can also ask for: * visa costs for the person's partner and dependent children * essential associated costs, such as travel to attend appointments at a visa application centre or embassy, and essential English language tests * Immigration Health Surcharge costs for the person, their partner and dependent children if they will be in the UK for six months or more.

#### Disability-related adjustment support Show If you or a member of staff working on your grant is disabled or has a long-term health condition, you can ask for adjustment support to help you carry out your project.

Costs can include, but are not limited to: * additional costs for staff to help with day-to-day activities related to your project * assistive technology to help use computers, research equipment or materials – for example, text to audio software * care costs for assistance animals if you need to travel. We will not pay for capital or building costs, such as access ramps.

You can ask for these costs if your government and/or employer: * does not cover any of the costs * only covers some of the costs (if they do, we will only meet the shortfall). The costs we provide must not replace the support you may get from the government or your organisation, who are responsible for providing these costs. If you don't know what these costs are now, you canask for them after we've awarded your grant.

### materials and consumables Show We will pay for the materials and consumables you need to carry out your project, including: * laboratory chemicals and materials (for example reagents, isotopes, peptides, enzymes, antibodies, gases, proteins, cell/tissue/bacterial culture, plasticware and glassware) * project-specific personal protective equipment (PPE) that is above the standard expected for the setting * printing associated with fieldwork and empirical research * associated charges for shipping, delivery and freight.

We will provide funds if you need to outsource specialised elements of the project to organisations that are not already involved as applicants or collaborators, on a fee-for-service basis.

This work can include: * synthesising compounds or reagents * building medical devices * preclinical studies, such as toxicology or pharmacology studies * undertaking large scale data analysis Where multiple Contract Research Organisations are involved in a project, use a separate line item to request costs relating to each one.

You can ask for the cost of access to shared equipment, facilities or services if they’re essential to your project.

These may include materials and consumables, plus a proportion of: * maintenance and service contracts * staff time costs for dedicated technical staff employed to operate the equipment or facility We don’t cover the costs of: * depreciation or insurance * other staff, for example, contributions towards departmental technical, administrative and management staff time We do cover these costs if related to animal housing facilities.

If the facilities or equipment were paid for by a Wellcome grant, you can only ask for access charges if: * any support for running costs and maintenance contracts has ended You can ask for the equipment you need to carry out your project where: * it is not available at your administering organisation or through collaborations, and * you will be the main user, with priority access to it.

At least 50% of the use must be for Wellcome-funded activities. This can include small multi-use pieces of equipment such as desktop microscopes or shakers. Costs may include purchase, delivery, installation, maintenance and training, where necessary.

You can purchase second-hand equipment if it is more environmentally sustainable to do so. We will cover VAT and import duties if: * the usual UK exemptions on equipment used for medical research don’t apply * you’re applying from a non-UK organisation, and you can show these