Issued on: 8 December 2022
Deadline: 24 January 2023
The World Health Organization (WHO) is seeking experts to serve as members of the Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials. This “Call for experts” provides information about the advisory group in question, the expert profiles being sought, the process to express interest, and the process of selection.
Background
World Health Assembly Resolution 75.8 “Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination” was adopted by the 75th World Health Assembly in May 2022. The resolution requested that the WHO Secretariat review existing guidance and develop, following the standard WHO processes, new guidance as needed on best practices for clinical trials, including on strengthening the infrastructure needed for clinical trials, to be applied in normal times and with provisions for application during a public health emergency of international concern, taking into account relevant initiatives and guidelines as appropriate, as appropriate: (a) guidance on best practices to help to guide Member States’ implementation of scientifically and ethically sound clinical trials within their national and regional contexts; (b) guidance on best practices for non-State actors in the design and conduct of clinical trials and in strengthening the global clinical trial ecosystem to meet the needs of major population groups that the intervention is intended to benefit, with a particular focus on under-represented populations. This advisory group (AG) will advise the Secretariat on the work above.
Functions of the Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials
In its capacity as an advisory body to WHO, the AG shall have the following functions:
- Advising WHO on draft guidance on best practices to help to guide Member States’ implementation of scientifically and ethically sound clinical trials within their national and regional contexts;
- Advising WHO on guidance on best practices for non-State actors in the design and conduct of clinical trials and in strengthening the global clinical trial ecosystem to meet the needs of major population groups that the intervention is intended to benefit, with a particular focus on under-represented populations;
- Assisting WHO in identifying existing guidance and ongoing initiatives of relevance and ensuring that WHO’s work is complementary to ongoing initiatives, as appropriate;
- The AG should ensure that the focus on under-represented populations, and needs-driven research is adequately captured in the guidance developed;
- The AG will advise WHO in communicating and liaising with stakeholders related to clinical trials, including clinical researchers, national regulatory authorities, research ethics committees, patients and affected communities;
- The AG will advise on how WHO’s guidance can assist in sustainability of infrastructure strengthening for clinical trials;
- The AG will ensure that guidance adequately captures needs for high quality trials and strengthening of capacity in normal times, with advising WHO on the development of procedures in place in every Member State for rapid implementation of clinical trial protocols in times of health emergencies.
Operations of the Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials
The Advisory Group will meet virtually at least 3 times each year until completion of the guidance. They will support drafting of the guidance and review of draft and proposed final guidance once available. The working language of the group will be English.
Who can express interest?
The Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials will be multidisciplinary, with members who have a range of technical knowledge, skills and experience relevant to best practices in clinical trials, and strengthening the clinical trials ecosystem. Approximately 12 may be selected.
WHO welcomes expressions of interest from:
Scientists, healthcare professionals, healthcare regulators or others with expertise in the following areas:
- clinical trial design,
- network coordination,
- infrastructure and research capacity strengthening,
- regulatory authority clinical trial approval and authorization of medical products,
- ethics in research and emergency public health response,
- patient and community engagement,
- needs of under-represented populations, such as women, particularly pregnant and lactating women, and children
- relevance of results for guidelines processes
Submitting your expression of interest
To register your interest in being considered for the Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials, please submit the following documents by 23:59 Geneva time on January 24th 2023 to WHA758@who.int using the subject line “Expression of interest for the Technical Advisory Group on Development of Guidance on Best Practices for Clinical Trials:
- A cover letter, indicating your motivation to apply and how you satisfy the selection criteria. Please note that, if selected, membership will be in a personal capacity. Therefore do not use the letterhead or other identification of your employer;
- Your curriculum vitae (including your nationality/ies) and
- A signed and completed Declaration of Interests (DOI) form for WHO Experts, available at https://www.who.int/about/ethics/declarations-of-interest.
After submission, your expression of interest will be reviewed by WHO. Due to an expected high volume of interest, only selected individuals will be informed.
Important information about the selection processes and conditions of appointment
Members of WHO advisory groups (AGs) must be free of any real, potential or apparent conflicts of interest. To this end, applicants are required to complete the WHO Declaration of Interests for WHO Experts, and the selection as a member of an AG is, amongst other things, dependent on WHO determining that there is no conflict of interest or that any identified conflicts could be appropriately managed (in addition to WHO’s evaluation of an applicant’s experience, expertise and motivation and other criteria).
All AG members will serve in their individual expert capacity and shall not represent any governments, any commercial industries or entities, any research, academic or civil society organizations, or any other bodies, entities, institutions or organizations. They are expected to fully comply with the Code of Conduct for WHO Experts (https://www.who.int/about/ethics/declarations-of-interest). AG members will be expected to sign and return a completed confidentiality undertaking prior to the beginning of the first meeting.
At any point during the selection process, telephone interviews may be scheduled between an applicant and the WHO Secretariat to enable WHO to ask questions relating to the applicant’s experience and expertise and/or to assess whether the applicant meets the criteria for membership in the relevant AG.
The selection of members of the AGs will be made by WHO in its sole discretion, taking into account the following (non-exclusive) criteria: relevant technical expertise; experience in international and country policy work; communication skills; and ability to work constructively with people from different cultural backgrounds and orientations. The selection of AG members will also take account of the need for diverse perspectives from different regions, especially from low and middle-income countries, and for gender balance.
If selected by WHO, proposed members will be sent an invitation letter and a Memorandum of Agreement. Appointment as a member of an AG will be subject to the proposed member returning to WHO the countersigned copy of these two documents.
WHO reserves the right to accept or reject any expression of interest , to annul the open call process and reject all expressions of interest at any time without incurring any liability to the affected applicant or applicants and without any obligation to inform the affected applicant or applicants of the grounds for WHO's action. WHO may also decide, at any time, not to proceed with the establishment of the AG, disband an existing TAG or modify the work of the AG.
WHO shall not in any way be obliged to reveal, or discuss with any applicant, how an expression of interest was assessed, or to provide any other information relating to the evaluation/selection process or to state the reasons for not choosing a member.
WHO may publish the names and a short biography of the selected individuals on the WHO internet.
AG members will not be remunerated for their services in relation to the AG or otherwise. Travel and accommodation expenses of AG members to participate in AG meetings will be covered by WHO in accordance with its applicable policies, rules and procedures.
The appointment will be limited in time as indicated in the letter of appointment.
If you have any questions about this “Call for experts”, please write to WHA758@who.int well before the applicable deadline.