Nordic Trial Alliance Nordic Cooperation in Clinical Research

Transcription

1 Nordic Trial Alliance Nordic Cooperation in Clinical Research Mia Bengtström Nordic Trial Alliance

2 Background Aim to strengthen clinical research in the Nordics Objective to contribute to sustainable Nordic welfare Facts An initiative from the Nordic Council of Ministries Hosted by NordForsk Funded by Nordic Council of Ministries and NordForsk Pilot project NTA Nordic Research Cooperation for better health

3 Background to NTA gap analysis Earlier trend with declining number of clinical studies in all Nordic countries Global pharma industry moved clinical studies eastward Complex regulatory situation = difficult for academic studies Companies don t know how to find researchers / trial sites Barriers impeding academia-industry-collaboration Nordic patients don t know how to find on-going clinical studies The potential in Nordic multi-centre studies not supported

4 Actions proposed Provide researchers and laymen with practical advice on clinical research Establish a Nordic website to relay information and communication to individual countries, networks, sites and investigators Help companies to find researchers and vice versa Identify barriers between academia and industry and ways to overcome these Help patients finding on-going/recruiting clinical studies available in their area of disease in the Nordic countries Produce an overview of Nordic research ethical review systems Present options for Nordic clinical research registers and transparency of data Identification of further gaps!

5 Nordic Trial Alliance Advisory Board Lars Køber, Professor and Senior Hospital Physician at Rigshospitalet Ralf w. Ackermann, Head of CMR, Medical Director, Novo Nordisk Scandinavia AB Pauli Puolakkainen, Professor Gastroenterology/-surgery, University of Helsinki Mia Bengtström, Pharma Industry Finland Salvör Nordal, member of the Nordic Committee on Bioethics and NORIA-net on Registries, Iceland Kristjan Erlendsson, Special Advisor in Science and Education to the Ministry of Welfare, and Landspitalinn the National University Hospital of Iceland Sameline Grimsgaard, Chair of the Expert Committee for Medicine, Health Sciences and Biology, Research Council of Norway, and Vice-Dean for Research at the Faculty for health sciences, University of Tromsø Ole Alexander Opdalshei, Assistant Secretary General, Norwegian Cancer Society Christina Åkerman, President at International Consortium for Health Outcomes Measurement (Chair) Mef Nilbert, Professor in Oncology, Head of Regional Cancer Centre South, Sweden

6 Activities NTA officially established with secretariat, advisory board & working group NTA website launched Stakeholder meetings with targeted focus: - identified areas in immediate need of strengthened clinical research infrastructure cooperation - ethical review procedures - Norden as a common clinical research area Targeted calls for: - infrastructure projects - multi-centre trials (to increase patient recruitment in Nordic projects or expand single-country projects to three Nordic countries)

7 NTA Infrastructure Projects Collaboration on ethical review of clinical research in the Nordic countries - Review and comparison of present systems - Propose documentation for joint Nordic studies Monitoring of Clinical Research - Increase the quality of and facilitate the monitoring process of clinical research - Nordic guidelines for monitoring Transparency and Registration - Stress importance that data is trustful and reproducable - Nordic report on Transparency and Registration Collaboration between Industry and Academia Pediatrics (strategic area) - Creating a Nordic network for medicines for children

8 NTA Pilot Projects Nordic Arthroplasty Register Association - an international quality register study of total joint arthroplasty of four nations (PI Keijo Mäkälä, FIN) Assisted reproductive technology (ART) and safety in the Nordic countries - the Committee of Nordic ART and Safety (PI Anja Pinborg, DK) NordStar - the most effective treatment strategy in early rheumatoid arthritis comparing four different treatments (PI Merete Hetland, DK) BMT (bone marrow transplantation) in elderly AML (acute myeloid leukemia) - a prospective, controlled, international study (PI Mats Brune, SE) Discontinuation of infliximab therapy in patients with Crohns' disease during sustained complete remission (PI Mark Ainsworth, DK) Total budget 16 MNOK Projects funded with 2-4 MNOK each Some projects completed, some still ongoing

9 NTA strategic projects 2016/17 - increasing Nordic collaboration by reducing cross-border barriers 1. Workshop on Cross-border Participation in Clinical Trials Patient access to on-going clinical studies in other Nordic countries 2. Harmonised Nordic Ethical Evaluation of Clinical Trials A common Nordic Research area 3. Nordic Conferences on Real-World Data Highlighting the potential of Nordic register and biobank data for the international Life Science Industry 4. Establishing a Nordic Network for Clinical Trials in Children stage II Openings for a European lead by the Nordic consortium 5. Nordic Hotspot for Life Science Analysis of how the Nordic area could develop into a superzone for Life Sciences 6. Nordic Monitoring Network Updating a map on all Nordic sites involved in academic clinical research 7. Nordic Network on antimicrobial multi-resistance research 8. Nordic conference on pragmatic clinical trials

10 Results NTA have provided a web portal for laymen, researchers and companies for easy access to o o Nordic clinical research sites Ongoing clinical research in all Nordic countries NTA have supported a series of Nordic infrastructure projects leading to concrete hands-on support to patients, researchers and industry NTA has supported several cross-border Nordic clinical research projects of great importance to patients NTA have identified new gaps and have issued several short-term strategic projects to further explore how collaboration could increase over Nordic borders

11 NTA NTA enters a new phase NTA 2.0 personalised medicine NTA is part of the Norwegian presidency project 2017 Nordic research cooperation for better health - A Nordic Commons for Health Data - NTA Research Ethics NTA 2.0 will be run by NordForsk as an activity within the Nordic Programme on Health and Welfare A new working group responsible for this project is to be appointed

12 NTA 2.0 personalised medicine The Nordic Trial Alliance will focus on: Facilitation of clinical study cooperation between clinics and research groups in the Nordic countries, and between clinical environments, academia and industry Increasing the knowledge of opportunities to participate in studies among patients and their attending physicians Increasing access to clinical infrastructure across the Nordic countries Sharing experience and expertise in clinical trials on personalised medicine Facilitation the use of clinical quality registers and real world data in clinical research

13 Activities forseen Annual stakeholders meetings, conferences and workshops Support of Nordic network activities aiming to fulfill NTA aims Pilot call for a Nordic trial related to personalised medicine Development of the NTA website Activities will be announced on the NTA website

14 Welcome to Nordic Conference on Pragmatic Clinical Studies December 2017, Uppsala, Sweden Limited conference grants for academic researchers and public healthcare staff within the Nordic countries Apply by Thursday, October 5

15 nta.nordforsk.org

16