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WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L'EUROPE WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ REGIONALBÜRO FÜR EUROPA ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО Regional Consultation on Strengthening /1 Clinical Research and Trial Ecosystem in the WHO European Region In-person meeting 10-11 June 2025 01 April 2025 Prague, Czechia 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]> Saaja: "Agne Nettan-Sepp, Helen Sõber, Karmen Joller - SOM" <[email protected]> Teema: Reminder: Nomination request: WHO consultation on strengthening clinical research CRM:0323163 Kuupäev: 2025-04-29 14:34 Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear esteemed colleagues, We are writing to follow up on the attached request for nominations for the upcoming Technical consultation on strengthening clinical research and trial ecosystem in the WHO European Region which will take place on 10 - 11 June 2025 in Prague, Czech Republic. We would be very grateful if you could kindly send your country’s nomination no later than 5 May 2025. Please address your reply giving the name, functional title and email address of the proposed participant to the WHO Data, Evidence and Digital Health unit at [email protected]. We shall then communicate with the participants directly and provide them with the necessary documentation 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/. We also would like to remind you to kindly disseminate the survey with relevant professionals working in 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. All additional information about this technical consultation can be found in the attached letter. We would like to take this opportunity to thank you for the continuous and fruitful collaboration. Best regards, Data, Evidence and Digital Health Unit World Health Organization Regional Office for Europe UN City, Marmorvej 51, DK-2100 Copenhagen, Denmark European Region website: https://www.who.int/europe/home Global website: http://www.who.int/en/ From: WHO/EURO Data, Metrics and Analytics &lt;[email protected]&gt; Sent: Monday, April 14, 2025 3:43 PM To: [email protected]; Helen Sõber &lt;[email protected]&gt;; Karmen Joller &lt;[email protected]&gt; Cc: Helen Sõber &lt;[email protected]&gt;; Agne Nettan-Sepp &lt;[email protected]&gt;; [email protected]; Riia Salsa-Audiffren &lt;[email protected]&gt;; [email protected]; Andre Pung &lt;[email protected]&gt;; KÖHLER, Kristina &lt;[email protected]&gt; Subject: Nomination request: WHO consultation on strengthening clinical research CRM:0323163 Please see the attached correspondence sent from the World Health Organization, Regional Office for Europe. One or more attachments may be included. Veuillez vous référer à la correspondance ci-jointe du Bureau régional de l'Europe de l'Organisation mondiale de la santé. Une ou plusieurs annexes peuvent être jointes. Mit der Bitte um Kenntnisnahme der beiliegenden Korrespondenz (eine oder mehrere Anlagen), Weltgesundheitsorganisation, Regionalbüro für Europa См. прикрепленные письма от Европейского регионального бюро Всемирной организации здравоохранения (один или несколько прикрепленных файлов). Saatja: WHO/EURO Data, Metrics and Analytics <[email protected]> Saadetud: 29.04.2025 17:34 Adressaat: <"Agne Nettan-Sepp">; <=?utf-8?Q?Helen_S=C3=B5ber?=>; Karmen Joller - SOM <[email protected]> Koopia: <=?utf-8?Q?Helen_S=C3=B5ber?=>; <"Agne Nettan-Sepp">; Info - SOM <[email protected]>; Riia Salsa-Audiffren <[email protected]>; <[email protected]>; Andre Pung <[email protected]>; KÖHLER, Kristina <[email protected]> Teema: Reminder: Nomination request: WHO consultation on strengthening clinical research CRM:0323163 Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.Tundmatu saatja korral palume linke ja faile mitte avada.Dear esteemed colleagues, We are writing to follow up on the attached request for nominations for the upcoming Technical consultation on strengthening clinical research and trial ecosystem in the WHO European Region which will take place on 10 - 11 June 2025 in Prague, Czech Republic. We would be very grateful if you could kindly send your country¡¯s nomination no later than 5 May 2025. Please address your reply giving the name, functional title and email address of the proposed participant to the WHO Data, Evidence and Digital Health unit at . We shall then communicate with the participants directly and provide them with the necessary documentation and administrative information in due course. We also kindly ask the nominated participant to register for the event using this link: . We also would like to remind you to kindly disseminate the survey with relevant professionals working in 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. All additional information about this technical consultation can be found in the attached letter. We would like to take this opportunity to thank you for the continuous and fruitful collaboration. Best regards, Data, Evidence and Digital Health Unit World Health Organization Regional Office for Europe UN City, Marmorvej 51, DK-2100 Copenhagen, Denmark European Region website: Global website: From: WHO/EURO Data, Metrics and Analytics &lt;[email protected]&gt; Sent: Monday, April 14, 2025 3:43 PMTo: [email protected]; Helen Sõber &lt;[email protected]&gt;; Karmen Joller &lt;[email protected]&gt;Cc: Helen Sõber &lt;[email protected]&gt;; Agne Nettan-Sepp &lt;[email protected]&gt;; [email protected]; Riia Salsa- Audiffren &lt;[email protected]&gt;; [email protected]; Andre Pung &lt;[email protected]&gt;; KÖHLER, Kristina &lt;[email protected]&gt;Subject: Nomination request: WHO consultation on strengthening clinical research CRM:0323163 Please see the attached correspondence sent from the World Health Organization, Regional Office for Europe. One or more attachments may be included.Veuillez vous r¨¦f¨¦rer ¨¤ la correspondance ci-jointe du Bureau r¨¦gional de l'Europe de l'Organisation mondiale de la sant¨¦. Une ou plusieurs annexes peuvent ¨ºtre jointes.Mit der Bitte um Kenntnisnahme der beiliegenden Korrespondenz (eine oder mehrere Anlagen), Weltgesundheitsorganisation, Regionalb¨¹ro f¨¹r Europa§³§Þ. §á§â§Ú§Ü§â§Ö§á§Ý§Ö§ß§ß§í§Ö §á§Ú§ã§î§Þ§Ñ §à§ä §¦§Ó§â§à§á§Ö§Û§ã§Ü§à§Ô§à §â§Ö§Ô§Ú§à§ß§Ñ§Ý§î§ß§à§Ô§à §Ò§ð§â§à §£§ã§Ö§Þ§Ú§â§ß§à§Û §à§â§Ô§Ñ§ß§Ú§Ù§Ñ§è§Ú§Ú §Ù§Õ§â§Ñ§Ó§à§à§ç§â§Ñ§ß§Ö§ß§Ú§ñ (§à§Õ§Ú§ß §Ú§Ý§Ú §ß§Ö§ã§Ü§à§Ý§î§Ü§à §á§â§Ú§Ü§â§Ö§á§Ý§Ö§ß§ß§í§ç §æ§Ñ§Û§Ý§à§Ó). WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ Date: 10 April 2025 REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L’EUROPE Dr Karmen Joller REGIONALBÜRO FÜR EUROPA Minister of Social Affairs ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО Ministry of Social Affairs Head office: Suur-Ameerika 1 UN City, Marmorvej 51, 10129 Tallinn DK-2100 Copenhagen Ø, Denmark Tel.: +45 45 33 70 00; Fax: +45 45 33 70 01 Estonia Email: [email protected] Website: https://www.who.int/europe Our reference: Your reference: Notre référence: Votre référence: Unser Zeichen: Ihr Zeichen: См. наш номер: 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 UN City, Marmorvej 51 Tel.: +45 45 33 70 00 Email: [email protected] DK-2100 Copenhagen Ø Fax: +45 45 33 70 01 Website: https://www.who.int/europe Denmark  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 –2– WORLD HEALTH ORGANIZATION ORGANISATION MONDIALE DE LA SANTÉ REGIONAL OFFICE FOR EUROPE BUREAU RÉGIONAL DE L'EUROPE WELTGESUNDHEITSORGANISATION ВСЕМИРНАЯ ОРГАНИЗАЦИЯ ЗДРАВООХРАНЕНИЯ REGIONALBÜRO FÜR EUROPA ЕВРОПЕЙСКОЕ РЕГИОНАЛЬНОЕ БЮРО Regional Consultation on /3 Strengthening Clinical Research and Trial Ecosystem in the WHO European Region 10-11 June 2025 10 April 2025 Prague, Czechia 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