EDCTP Scientific Advisory Committee – Call for Experts in implementation research and biomedical ethics

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 as well as oversight of the scientific integrity of the EDCTP programme. The SAC assists the Executive Secretariat in ensuring that the EDCTP2 annual work plans are developed in the context of global activities, taking into account the dynamic state of product development pipelines, and the national plans, needs and priorities of the African and European participating member states. SAC members serve in their personal capacity, representing a broad range of disciplines encompassing all aspects of clinical trials in poverty-related infectious diseases in sub-Saharan Africa within the EDCTP scope.*

EDCTP is seeking two high-level experts in the fields of implementation research and ethics to join the SAC in 2017. Applicants should have an outstanding track record and extensive experience of working in sub-Saharan Africa in:

Implementation research on strategies to deliver, improve access or increase the use of available or new clinical interventions (diagnostics, drugs, vaccines or microbicides);
and/or
Biomedical ethics relating to clinical trials research in low and middle income countries, including experience in issues such as informed consent, trial participation and compensation, patient representative groups and community advisory boards.

In addition, experts should have skills, knowledge, expertise in one or more of the following fields:

  • Poverty-related infectious diseases in the scope of the EDCTP2 programme
  • Clinical trials and clinical research, especially in sub-Saharan Africa
  • Research capacity strengthening and training
  • Public health (including epidemiology, biostatistics, health economics, global health, maternal and child health)
  • Post-registration safety and effectiveness programmes
  • Social and behavioural sciences within the disease scope of EDCTP2
  • Policy development, good participatory practice, and advocacy.

 

Mandate of the SAC

As the scientific and strategic advisory body to EDCTP, the SAC prepares an annual Strategic Research Agenda. This Strategic Research Agenda forms the basis for the EDCTP annual work plan. The SAC is supported by the Executive Secretariat and reports to the General Assembly. The mandate of the SAC shall be as follows:

Strategic planning

  • Assist in the designing 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 General Assembly and the Executive Secretariat 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 poverty-related infectious diseases 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 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 & evaluation

  • Support and provide input into the monitoring & evaluation framework for EDCTP2
  • Provide input for the monitoring of scientific outcomes and strategic impacts of EDCTP-funded grants
  • The SAC Chairperson shall prepare an annual report on the SAC activities and achievements of the previous year for submission to the General Assembly. The report shall include a summary detailing the strategic and scientific advice provided to the Executive Secretariat 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 Executive Secretariat 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 remit; and gender.

Appointment

Appointments to the SAC are approved by the General Assembly 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 remit; 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 a minimum of 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 of working documents and act as “rapporteurs” on an ad hoc basis. Candidates should also take into account that preparatory work is required prior the meetings. The working language of the SAC is English. SAC members shall adhere to the EDCTP internal regulations and to EDCTP Code of Conduct and Declaration of Interests Policy. EDCTP will make public relevant information and documents on its website, while excluding confidential information. Personal data will be collected, processed and published in accordance with the Personal Data Protection Act of The Netherlands.

Application procedure and deadline for registration

Applicants are requested to download and complete the Application Form and submit it to proposals[at]edctp.org by 28 February 2017. Applications received after this date may be considered for the replacement of resigning experts and renewal of SAC membership.

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 EDCTP2;
  • 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 taken into account:

  • The need to strike a balance within the SAC in terms of representativeness of stakeholders, 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[at]edctp.org.

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 14 countries in sub-Saharan Africa (Burkina Faso, Cameroon, Congo, Gabon, The Gambia, Ghana, Mali, Mozambique, Niger, Senegal, South Africa, Tanzania, Uganda and Zambia), and supported by the European Union (EU).

EDCTP was established by the EU in 2003 in response to the global health crisis caused by the three major poverty-related infectious 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 infectious diseases* in sub-Saharan Africa including emerging infectious diseases of particular 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 poverty-related infectious diseases, including neglected infectious diseases and emerging or re-emerging infectious diseases of particular relevance for Africa;
  2. Strengthen cooperation with sub-Saharan African countries, in particular in building 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.

 

*In the EDCTP2 programme, poverty-related infectious diseases include: HIV/AIDS, tuberculosis, malaria; neglected infectious diseases (dengue/severe dengue; rabies; human African trypanosomiasis (sleeping sickness); leishmaniases; cysticercosis/taeniasis; dracunculiasis (guinea-worm disease); echinococcosis; foodborne trematodiases; lymphatic filariasis; onchocerciasis (river blindness); schistosomiasis; soil-transmitted helminthiases; Buruli ulcer; leprosy (Hansen disease); trachoma; yaws); diarrhoeal infections; lower respiratory infections; as well as emerging or re-emerging infectious diseases of particular relevance for Africa, such as Ebola or yellow fever.