Purpose of the Consultancy

The 75th World Health Assembly resolution (WHA8) calls upon WHO to prepare global guidance on best practices to help Member States implement scientifically and ethically sound clinical trials. The resolution also provides guidance on best practices for nonState actors in designing and conducting clinical trials and strengthens the global clinical trial ecosystem. The main purpose of this consultancy assignment is to map the current landscape of clinical trials in Viet Nam, including regulatory and ethical issues that are the basis of clinical trials. The initiative will also look into gaps, challenges, and factors that facilitate the process.

Background

WHO Office for the Western Pacific (WPRorganized an expert consultation meeting in March 2024 as part of a series of regional consultations that also took place in AFRO, EMRO, and SEARO. The consultation was used to identify input for WPRO/DSI to set its implementation agenda of WHA 8 in Member States of the Western Pacific Region. The Selangor Consensus, a Comment based on the meeting output, was published on The Lancet Regional Health – Western Pacific. Key recommendations include putting equity at the center of developing and conducting clinical trials, building local ecosystem for clinical trials through equitable international partnerships, integrating clinical trials into public health systems, and leveraging registries as a vehicle to promote strengthen data governance and promote research.

Following the consultation, the next step involves conducting situation analysis of clinical trial in a selected few Member States to address aforementioned priorities. WHO is looking for a consultant based in Viet Nam to help conduct the situation analysis of clinical trial ecosystem in Viet Nam.

Deliverables

The consultant is assigned to:

Output 1: Map the national ecosystem of clinical trials in Viet Nam

Deliverable 1: Map key stakeholders involved in the development and conduct of clinical trials, their roles and responsibilities, as well as activities.
Deliverable 2: Conduct field visits to clinical trial sites and key informant interviews with relevant clinical researchers, national ethics committee members, and regulators
Deliverable 3: Review clinical trials guidelines and procedures in place in Viet Nam and provide a report that captures the situation of scientific, ethical, and logistics/project management aspects of the design, conduct, and reporting of clinical trials.

Output 2: Develop the agenda for a Hanoibased workshop on clinical trials

Deliverable 1: Support the development of workshop agenda and identify key stakeholders to be invited to the workshop.
Deliverable 2: Final report on the national ecosystem of clinical trials in Viet Nam

Qualifications, experience, skills and languages

Educational Qualifications:

Essential: First university degree in public health, epidemiology, health sciences, or a related discipline from a recognized institution.
Desirable: Master’s degree in public health, epidemiology, health sciences, or a related discipline.

Experience

Essential: Relevant experience conducting independent research, clinical trials, RCTs, data analysis and publishing public healthrelated issues in Viet Nam.
Desirable: Documented fieldbased experience and exposure to fieldwork in Viet Nam.
Experience with quantitative and/or qualitative research methodologies and experience applying them in the public health context.
Experience in supporting organizational and capacity development of national actors in an international context
Practical experience in working in support of national partner organizations, establishing and developing partnerships in Viet Nam.

Skills/knowledge:

Essential: Strong writing skills
Research and Analytical Skills
Communication and Reporting Skills

Language requirements:

Native Vietnamese speaker.
Excellent written and spoken knowledge of the English language.

Location

The consultant will perform the work from his/her office and communications will be through phone calls, exchange of emails and online meetings.

Travel

The consultant is expected to travel to conduct field visits.

Remuneration and budget

Remuneration:  USD 200 (dail
Duration: 25 days over 2 months period (parttim, November to December 2024

Additional Information:

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