Background
The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public-public partnership between 14 countries in Europe (Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, UK) and 16 countries in sub-Saharan Africa (Burkina Faso, Cameroon, Congo, Ethiopia, Gabon, The Gambia, Ghana, Mali, Mozambique, Niger, Nigeria, Senegal, South Africa, Tanzania, Uganda and Zambia), and supported by the European Union (EU). Angola and Switzerland participate as aspirant members of the EDCTP Association.

EDCTP was established by the EU in 2003 in response to the global health crisis caused by the three major poverty-related diseases (PRDs), HIV, tuberculosis and malaria. The first EDCTP programme (EDCTP1) ran from 2003-2015. The second EDCTP programme (EDCTP2) was launched on 2 December 2014 and will run over a ten-year period from 2014 to 2024. The EDCTP2 programme is implemented as part of the European Framework Programme for Research and Innovation, Horizon 2020. The European Union will provide a contribution of up to € 683 million for the 10-year programme (2014-2024), provided this is matched by contributions from the European Participating States.

The aim of EDCTP is to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV, tuberculosis and malaria as well as other poverty-related diseases (PRDs) in sub-Saharan Africa including emerging infectious diseases of relevance for Africa, through all phases of clinical trials with emphasis on phase II and III clinical trials.

The activities of the EDCTP2 programme will contribute towards achieving the following five specific objectives:

1. Increase the number of new or improved medical interventions for PRDs, including neglected ones and emerging infectious diseases of relevance for Africa
2. Strengthen cooperation with sub-Saharan African countries, in particular in developing their capacity for conducting innovative research for clinical interventions in compliance with fundamental ethical principles and relevant national, EU and international legislation
3. Better coordinate, align and, where appropriate, integrate relevant national programmes to increase the cost-effectiveness of European public investments
4. Extend international cooperation with other public and private partners to ensure that the impact of all research is maximised and that synergies can be taken into consideration and to achieve leveraging of resources and investments
5. Increase impact due to effective cooperation with relevant EU initiatives, including its development assistance.

 

Scope of the Call
The Scientific Advisory Committee (SAC) is the principal advisory group to EDCTP, providing strategic and scientific advice to the EDCTP General Assembly and the Executive Secretariat (SEC) as well as oversight of the scientific integrity of the EDCTP programme. The SAC assists the SEC in ensuring that the EDCTP2 annual work plans are developed in the context of global activities and take into account the dynamic state of product development pipelines, and the national plans, needs and priorities of the African and European EDCTP member states.

EDCTP is calling on high-level experts from across multiple fields and sectors to apply to become members of the SAC from January 2019. SAC members shall serve in their personal capacity, representing a broad range of disciplines encompassing all aspects of clinical trials in poverty-related diseases (PRDs) in sub-Saharan Africa within EDCTPs mandate.

EDCTP is looking for up to seven new members to join the SAC. Experts should have skills, knowledge, expertise and standing in one or more of the following fields:

• PRDs in the scope of EDCTP2, especially in TB, malaria, lower respiratory tract infections, diarrhoeal diseases, co-infections and co-morbidities
• Public health (including epidemiology, biostatistics, health economics, maternal and child health, social and behavioural sciences, implementation research)
• Clinical trials and clinical research, especially in sub-Saharan Africa
• Product development and clinical regulatory affairs
• Post registration safety and effectiveness programmes
• Research capacity strengthening and training
• Ethics

 

Mandate of the SAC
As the scientific and strategic advisory body to EDCTP, the SAC prepares a Strategic Research Agenda (SRA). This SRA underpins and forms the basis for the EDCTP annual work plan.

The SAC may operate as a single forum and with specialist subgroups to develop strategy and to advise on implementation plans. The SAC is supported by the SEC and reports to the GA.

The mandate of the SAC shall be as follows:

Strategic planning

• Assist in the design of the strategic and scientific framework of the EDCTP programme
• Advise on the development of the EDCTP annual workplans for approval by the GA
• Advise on strategies to foster synergies and partnerships with stakeholders in the North and South
• Contribute to the preparation of strategic and scientific documents relevant to EDCTP, as required
• Provide strategic and scientific advice to the GA and the SEC to ensure the successful completion of on-going projects
• Identify strategic needs and priorities for accelerating the development of new or improved clinical interventions, including the required training, networking and capacity building to be undertaken to achieve these objectives
• Review the landscape of PRDs to identify the role that EDCTP should play in partnership with other stakeholders to accelerate the development or improvement of interventions against these diseases
• Assess the state of global product development pathways and the critical path opportunities for future product development
• Provide advice on the launch and review of any calls for proposals and other programmes.

 

Reporting and monitoring and evaluation

• Support and provide input into the monitoring and evaluation framework for EDCTP2
• Provide input in the monitoring of scientific outcomes and strategic impacts of EDCTP-funded grants
• The SAC Chairperson shall prepare an annual report on the previous year’s SAC activities and achievements for submission to the GA. The report shall include a summary detailing the strategic and scientific advice provided to the SEC throughout the year.

 

Advocacy and representation at meetings and events

• Participate in EDCTP working groups, stakeholder meetings and the EDCTP Forum
• Advise and assist in the organisation of workshops, meetings and other relevant events.

 

A key role of the SAC will be to assess the state of global product development pathways and the critical paths for future product development. The SAC will work with the SEC to identify opportunities to coordinate calls in specific fields as products become available or to hold initiatives to broker activities based on the state of the field.

Composition of the SAC

SAC Chairperson
SAC Vice Chairpersons (maximum 2)
SAC Ordinary Members (maximum 14)

SAC observers (non-voting):

• GA Chairperson
• The EDCTP Executive Director (ED) and or his/her representative(s) in the role of SAC Secretary
• External observers.

In as far as possible, the SAC shall be balanced in terms of North-South representation; professional affiliation (academia, clinical practice, research institute, private sector, government, civil society); disease specialisation and other expertise relevant to the EDCTP scope; and gender.

Appointment
Appointments to the SAC are approved by the EDCTP Board based on the following criteria:

• Track record and achievements in fields of relevance to EDCTP
• Commitment to the goals and objectives of EDCTP
• Experience and expertise in cross-cutting issues, including capacity building, research ethics, regulatory affairs, collaborative programmes (North-South, North-North, South-South)
• The need to achieve a balanced membership in terms of north-south representation with preference for European and African experts; professional affiliation; disease specialisation relevant to the EDCTP scope; expertise across multiple sectors; age and gender (without calling into question the necessary level of expertise and insight).

The SAC will comprise up to 17 members (the Chair, two Vice-Chairs and up to fourteen ordinary members). Appointments to the SAC are for a three-year period, which may be extended once for a further two years.

Individuals shall be appointed in their personal capacity – i.e. experts with outstanding knowledge in their field acting independently and in the public interest. They should not represent collective interests or be affiliated to private organisations which may benefit from the work of the Committee.

Terms of participation
The SAC will meet at least twice per year. Candidates should be prepared to attend meetings consistently, examine and provide comments on documents under discussion, contribute actively to discussions in the committee and where necessary contribute to drafting working documents and act as “rapporteurs” on an ad hoc basis. Candidates should also take into account that preparatory work is required prior to the meetings. The working language of the SAC is English. SAC members shall adhere to the EDCTP internal regulations and to the EDCTP Code of conduct and declarations of interest policy.

Protection of Personal Data
Personal data will be collected, processed and published in accordance with EDCTP’s Privacy policy. Any processing of personal data related to the recruitment of SAC members is based on consent. By applying to become a member of SAC, you have given us consent to hold and process your personal data. The data you provide will be processed for the purpose of the recruitment procedure and will only be accessed by persons who need to do so for this purpose. Your data will be kept in our system up to one month after the completion of the recruitment procedure (should your application be unsuccessful). The names of our SAC members (successful applicants) will be published on the EDCTP website. (SAC members will also be requested to provide a short bio and picture for publication). EDCTP will make public relevant information and documents on its website reflecting the work of the SAC.

Application procedure and deadline for registration
Applicants are requested to download and complete the Application Form and submit the application form, a up-to-date CV and a list of publications from the past five years to proposals@edctp.org
by 21 October 2018.

Selection
EDCTP will take the following criteria into account when assessing the registered candidates individually:

• Proven competence and experience of the individual candidate in areas of relevance to EDCTP
• Scientific track record and commitment to promoting clinical research in sub-Saharan Africa
• Experience in clinical research or clinical trials, product development, capacity building, health research ethics, public health, health economics and networking.

 

To ensure a balanced membership, the following selection criteria will be considered:

• The need to strike a balance within the SAC in terms of representativeness of stakeholders, expertise, gender, age and geographical origin (without compromising the excellence in the required expertise).

 

Logistical and operational aspects
SAC meetings are normally held at the EDCTP offices in The Hague, The Netherlands or Cape Town, South Africa, or in another location announced in accordance with the procedures and schedule established by EDCTP. SAC members receive an honorarium, in addition to travel and subsistence expenses incurred in relation to activities conducted under SAC membership.

For further information and enquiries please contact proposals@edctp.org

 

* Note: On 27 September 2018, the deadline for applications was changed from 30 September 2018 to 21 October 2018.