WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR EUROPE WELTGESUNDHEITSORGANISATION REGIONALBÜRO FÜR EUROPA

ORGANISATION MONDIALE DE LA SANTÉ BUREAU RÉGIONAL DE L'EUROPE

ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ

ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО

Regional Consultation on Strengthening Clinical Research and Trial Ecosystem in the WHO European Region

/3

10-11 June 2025 Prague, Czechia

10 April 2025 Original: English

Provisional agenda

1. Welcome and opening remarks

2. Setting the scene for strengthening clinical research and trial ecosystem in the WHO European Region

3. Paving the way forward for strengthening clinical research and trial ecosystem: Guidance for Best Practices for Clinical Trials and Draft Global Action Plan for Clinical Trial Ecosystem Strengthening

4. Challenges and barriers of clinical research ecosystems in the WHO European Region countries

5. Facilitated group work

6. Strengths, opportunities and good practices in the WHO European Region

7. Regional spotlight – secondary use of data and artificial intelligence in clinical trials

8. Regional spotlight – enabling better evidence for decisions

9. Resources, tools and ways forward for strengthening clinical research and trial ecosystem

10. Wrap up and closing remarks

WORLD HEALTH ORGANIZATION

REGIONAL OFFICE FOR EUROPE

WELTGESUNDHEITSORGANISATION

REGIONALBÜRO FÜR EUROPA

ORGANISATION MONDIALE DE LA SANTÉ

BUREAU RÉGIONAL DE L'EUROPE

ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ

ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО

Regional Consultation on Strengthening Clinical Research and Trial Ecosystem in the WHO European Region

/1

In-person meeting 10-11 June 2025 Prague, Czechia

01 April 2025 Original: English

Scope and purpose

Background

The European Programme of Work (EPW) and the ongoing process of developing the EPW2

recognizes the crucial role of science, research and evidence in advancing health across Europe

and addressing complex health challenges in a rapidly changing world. While the EPW

emphasizes leveraging research and innovation to identify effective solutions, recent insights

have highlighted significant challenges within the clinical research and development ecosystem.

These challenges reveal underutilized potential and create barriers to timely access to effective

treatments and health interventions. The 75th World Health Assembly resolution (WHA75.8)1

called for Global Guidance on Best Practices for Implementing Scientifically and Ethically

Sound Clinical Trials. This guidance addresses the current paradigm where clinical trials often

prioritize commercial interests over public health needs, leading to a disconnect between

research efforts and societal health priorities.

The development of this guidance began in January 2023, involving a Technical Advisory Group

(TAG) of global experts in clinical trials, health research methodology, regulation, and ethics.

The process included extensive consultations with a WHO Steering Committee and diverse

stakeholders. The WHO's first Global Clinical Trials Forum (GCTF) in November 2023 brought

together over 130 stakeholders from research institutions, regulatory bodies, ethics authorities,

patient organizations, funding agencies, and the healthcare industry. This forum highlighted the

need for a more coordinated approach to clinical research that is aligned with public health

priorities.

The resulting Global Action Plan for Clinical Trial Ecosystem Strengthening (GAP-CTS) aims

to operationalize strategies for maintaining and sustaining efficient clinical research

infrastructure, capabilities, and capacities, focusing on addressing unmet medical needs and

ensuring equitable access to treatments. The Guidance for Best Practices for Clinical Trials was

published in September 2024. It offers key scientific and ethical considerations for clinical trial

design and implementation and recommendations for strengthening national and global clinical

trial ecosystems.

1 Strengthening clinical trials1 to provide high-quality evidence on health interventions and to improve research quality and coordination:

https://apps.who.int/gb/ebwha/pdf_files/wha75/a75_r8-en.pdf

Scope and purpose Page 2

On that backdrop WHO Regional Office for Europe will host the consultation together with the

Science Division of the WHO Headquarters and WHO Country Office in Czechia to leverage the

global momentum generated by WHA75.8 and to achieve the following:

- to support and strengthen countries' capacities in conducting research and clinical trials

that generate high-quality evidence for health interventions and decision-making, and

- to contextualize evidence-based Guidance to improve health policy and practice, with a

particular focus on addressing the challenges of the European clinical development

landscape.

Consultation Objectives

The consultation is targeted towards informing Member States and stakeholders about WHA75.8

and presenting the guidance for best practices for clinical trials, emphasizing the need for a

paradigm shift in clinical trial design and implementation. It also aims to identify and discuss

regional challenges and priorities in clinical research and trial ecosystems, including barriers to

access and the misalignment between research focus and public health needs.

Format

The in-person consultation is planned for two full working days and will take place in Prague.

Participants

The consultation will bring together all nominated focal points from the 53 Member States of our

Region, actively involved in or responsible for the coordination and collaboration with various

national and international stakeholders in clinical research and trials at the national level and/or

organizing clinical research and trial guideline development at the national level.

Saatja: WHO/EURO Data, Metrics and Analytics <[email protected]>

Saadetud: 14.04.2025 16:42

Adressaat: <"Agne Nettan-Sepp">; <=?utf-8?Q?Helen_S=C3=B5ber?=>; Karmen

Joller <[email protected]>

Koopia: <=?utf-8?Q?Helen_S=C3=B5ber?=>; <"Agne Nettan-Sepp">;

<[email protected]>; Riia Salsa-Audiffren <[email protected]>;

<[email protected]>; Andre Pung <[email protected]>;

KÖHLER, Kristina <[email protected]>

Teema: Nomination request: WHO consultation on strengthening clinical

research CRM:0323163

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UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Denmark

Fax: +45 45 33 70 01 Website: https://www.who.int/europe

WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ

WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ

Date: 10 April 2025

Dr Karmen Joller

Minister of Social Affairs

Ministry of Social Affairs

Suur-Ameerika 1

10129 Tallinn

Estonia

REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L’EUROPE

REGIONALBÜRO FÜR EUROPA ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО

Head office:

UN City, Marmorvej 51, DK-2100 Copenhagen Ø, Denmark

Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01

Email: [email protected] Website: https://www.who.int/europe

Our reference: Notre référence: Unser Zeichen: См. наш номер:

Your reference: Votre référence: Ihr Zeichen: На Ваш номер:

Dear Madam,

Technical consultation on strengthening clinical research and trial ecosystem

in the WHO European Region, 10 – 11 June 2025

I have the pleasure to inform you that the World Health Organization Regional Office for Europe is

planning the above event. The European Programme of Work (EPW) emphasizes improving patient

outcomes and driving innovation. Recent insights, however, have highlighted significant challenges in

the clinical development space that hinder access to essential treatments. The 75th World Health

Assembly resolution (WHA75.8) called for Global Guidance on Best Practices for Implementing

Scientifically and Ethically Sound Clinical Trials. Published in 2024, this guidance addresses the

current paradigm where clinical trials often prioritize commercial interests over public health needs,

leading to a disconnect between research efforts and societal health priorities.

In order to leverage the global momentum generated by WHA75.8, WHO is hosting this in-person

regional technical consultation on 10 - 11 June 2025 in Prague, Czechia. The consultation will inform

Member States and stakeholders about WHA75.8 and present the guidance for best practices for

clinical trials, emphasizing the need for a paradigm shift in clinical trial design and implementation.

The consultation seeks to strengthen countries' capacities to conduct research and clinical trials that

generate high-quality evidence for health interventions and aims to contextualize evidence-based

guidance to improve health policy and practice. The working language will be English, with

simultaneous translation into Russian.

We would be grateful for your kind collaboration with the following:

1. We have the pleasure of inviting you to nominate one person to participate in this consultation.

This participant should be actively involved in or responsible for the coordination and

collaboration with various national and international stakeholders in clinical research and trials

at the national level and/or organizing clinical research and trial guideline development at the

national level. Please address your reply giving the name, functional title and email address of

the proposed participant at your earliest convenience but no later than 25 April 2025 to the

WHO Data, Evidence and Digital Health unit at [email protected]. We shall then

communicate with the participant directly and provide them with the necessary documentation

– 2 –

and administrative information in due course. We also kindly ask the nominated participant to

register for the event using this link: indico.un.org/event/1013916/registrations/17577/.

2. We also kindly ask you to disseminate the attached survey with relevant professionals working

at policy, research and academic roles at the local and national levels. Please assure them that

their responses will be treated with the utmost confidentiality and will be used solely for this

consultation process. We encourage national participation in this survey by 15 May 2025, as

the responses will provide us with valuable perspectives regarding key barriers and areas of

focus needed to improve the Clinical Trials ecosystem and thus inform the technical

consultation that will take place in Prague in June.

3. Finally, we request that you kindly provide us with names, functional titles and email

addresses of focal points on your National Ethics Committee who could provide more

information about their national activities. This information can also be sent to the WHO

Data, Evidence and Digital Health unit at [email protected]. Please send this at your earliest

convenience but no later than 15 May 2025.

Thank you very much for your kind consideration of the above requests. I would like to take this

opportunity to thank you for the continuous and fruitful collaboration.

Yours very truly,

Dr Natasha Azzopardi Muscat

Director

Division of Country Health Policies and Systems

WHO Regional Office for Europe

Encls:

Scope and purpose

Provisional agenda

Clinical research survey

Copy for information to:

Ms Helen Sõber, Adviser, European Union Affairs and International Co-operation Department, Ministry of

Social Affairs, Suur-Ameerika 1, 10122 Tallinn, Estonia

Ms Agne Nettan-Sepp, Head, European Union Affairs and International Co-operation Department, Ministry of

Social Affairs, Suur-Ameerika 1, 10129 Tallinn, Estonia

H.E. Ms Riia Salsa-Audiffren, Ambassador Representative of the Republic of Estonia, Permanent Mission of

the Republic of Estonia to the United Nations Office and other international organizations in Geneva, Chemin

du Petit-Saconnex 28A, CH-1209 Genève, Switzerland

H.E. Mr Andre Pung, Ambassador Extraordinary and Plenipotentiary, Embassy of the Republic of Estonia,

Frederiksgade 19, 4th floor, 1265 Copenhagen K, Denmark

Ms Kristina Köhler, Liaison Officer, WHO Country Office, Estonia, Paldiski Road 81, 10617 Tallinn, Estonia