Nordic Trial Alliance Nordic Cooperation in Clinical Research - - PowerPoint PPT Presentation

Nordic Trial Alliance Nordic Cooperation in Clinical Research - Report January 2016 Project Leader Pierre Lafolie MD, PhD Nordic Trial Alliance Karolinska Institutet

Nordic Trial Alliance - creating a Nordic clinical research infra-structure Aim Facts to strengthen clinical research § An initiative from the Nordic Council of Ministries Objective to contribute to sustainable § Part of Nordic welfare § Three year pilot project: 2013 – 2016 § Hosted by NordForsk § Funded by Nordic Council of Ministries and NordForsk http://nta.nordforsk.org

Nordic Trial Alliance WORK GROUP Maria Skoog Clinical trials Coordinator People BOARD The Copenhagen Trial Unit Copenhagen University Hospital, DK Lars Køber Professor, Copenhagen Christian Gluud Ralf w. Ackermann Head of Department Medical Director, Novo Nordisk, SECRETARIAT The Copenhagen Trial Unit Copenhagen Copenhagen University Hospital, DK Pauli Puolakkainen Professor, Helsinki Heli Pehrman Project leader Pierre Lafolie Mia Bengtström Research Funding Director MD, PhD, Pharma Industry Finland FinnMedi Oy, FIN Karolinska Institutet, SE Salvör Nordal Nordic Committee on Bioethics Halla Sigrún Arnardóttir Project assistant Sandra Chesley Iceland Project manager Karolinska Institutet, SE Kristjan Erlendsson , Clinical Research Center Special Advisor,Ministry of Welfare Landspitali University Hospital, IS Maria Nilsson Iceland Senior adviser, NordForsk Sameline Grimsgaard Sven M. Carlsen Vice-Dean Research Professor NordForsk administration and University of Tromsø Department of Cancer Research economy Ole Alexander Opdalshei and Molecular Medicine, NTNU, NO Ass. Secretary General Eivind Sætre/Tor Martin Nilsen Norwegian Cancer Society, Oslo Steinar Aamdal Communications advisers Christina Åkerman Professor II President ICHO, Boston (Chair) Department of Oncology Mef Nilbert University of Oslo Professor, Lund

Nordic Trial Alliance network and some stakeholders Iceland Small & medium enterprises, global industry Patients Researchers Hospitals Public NOS-M

The Context in which NTA started EU GCP Directive 2001/20 implemented 2004 • Leading to drastic decline in clinical research in all European countries • Countries adapted – but differently • Denmark launched early a national network of GCP-units and hubs for clinical research • EU started ECRIN • Slow progress in most Nordic countries • 2010 Nordic Council of Ministers launched a paper proposing a Nordic Clinical Research Infra-structure

NTA primary targets To Create a Nordic Clinical Research Infra-structure • Help researchers to identify tresholds and how to overcome them • Help companies to find researchers • Help Nordic patients to find on-going clinical research in their own country • Establish a web site connecting to Nordic national networks and research sites • Present an overview of Nordic research ethical review systems • Present options for Nordic clinical research registries and transparency of data • Identify Nordic barriers between academia and industry and propose how to overcome them • Initiate, support and develop relevant Nordic Networks in clinical research • Not to repeat what was done elsewhere!

NTA Implementation Projects - Those we did 1. Ethics 2. Monitoring of Clinical Research 3. Transparency and Registration 4. Collaboration between Industry and Academia 5. Pediatrics (strategic area)

Implementation projects -Those we didn’t do § Initially eight projects opened for application Other ideas were also issued by NTA for grant application, namely Legislation for clinical research in Nordic countries (Competent authorities,CA) Patient safety and AE reporting Design and statistical analysis Education and training Collaboration academia/industry - But for these project we received no applications!

NTA Pilot Projects § Five clinical research projects are onging, final reports will be prepared to Nordforsk when projects are ready § 16 miljon NOK in grant for Nordic Clinical Research § 20 applications arrived § An international committee top-ranked 5 projects

§ Nordic Arthroplasty Register Association - an international quality register study of total joint arthroplasty of four nations The aim of the register study is to analyze results of total hip arthroplasty and total knee arthroplasty in Nordic countries. The aim is also to develop a universal joint replacement database to detect inferior implants as early as possible. Project leader: Keijo Mäkälä, Finland Participating countries: Denmark, Finland, Norway, Sweden

§ CoNARTaS - Committee of Nordic ART and Safety Assisted reproductive technology (ART) and safety in the Nordic countries The project will use the CoNARTaS database to generate knowledge to optimise treatment programmes and create the best possible framework for all test-tube babies. Project leader: Anja Pinborg, Denmark Participating countries: Denmark, Finland, Norway, Sweden

§ NordStar The study aims to find out which is the most effective treatment strategy in early rheumatoid arthritis. As the first trial ever it will compare four different treatment modalities head-to-head. Project leader: Merete Lund Hetland, Denmark Participating countries: Denmark, Finland, Iceland, Norway, Sweden

§ BMT (bone marrow transplantation) in elderly AML - a prospective, controlled, international study Uses a novel study design allowing both HLA matched siblings and unrelated donors, and a strict scheme for registration, inclusion and allocation of patients to avoid selection biases. The trial has the potential to be the first to evaluate RIC* transplants in elderly AML (acute myeloid leukemia). Project leader: Mats Brune, Sweden Participating countries: Finland, Norway, Sweden (Australia, Canada, Estonia, Germany, Greece, New Zealand) * Reduced Intensity Conditioning

§ Discontinuation of infliximab therapy in patients with Crohns' disease during sustained complete remission A Nordic clinical trial that examines whether Remicade treatment can be stopped beneficially in patients in whom the disease is completely inactive, as determined by both a physicians assessment, examination of the intestines and blood tests. Project leader: Mark Ainsworth, Denmark Participating countries: Denmark, Faroe Islands, Finland, Iceland, Norway

NTA WEB services

NTA WEB services

NTA WEB services

NTA WEB services Listings of Nordic clinical trial units

Gap analysis § Nordic collaborative clinical research need a system for common Nordic research ethical review – would mean faster access and a large reduction in bureaucracy § Connecting Nordic Life Science clusters with Academia and University hospitals would support welfare sustainability by Tripod development § More similarities than differences between Nordic interventional and non-interventional clinical research § There is a LARGE need for funds for Nordic collaborative clinical research § Access of patients from one Nordic country to clinical studies ongoing in another Nordic country must be facilitated

Reflections and future work The project ends March 2016 There is a need for further development in terms of creating a common Nordic Research Area - The fastest way would be focusing on the research ethical review process There is also a need for further focus on Nordic registry trials and other non-interventional studies Small funds available for some actions during 2016 (meetings)

NTA want to extend a great THANK YOU to all contributors and participants!! For more information: www.nta.nordforsk.org Contact: pierre.lafolie@ki.se nta@nordforsk.org @nordforsk facebook.com/NordForsk

SWOT 2009 from Nordic Forum for Innovation in Health Care and Medicine on Challenges for Nordic Cooperation in Clinical Research STRENGTH WEAKNESS Excellent standard of authorities Small populations (and small markets) Excellent biobanks and registries National approvals High scientific standard of medical research Ethics committees require translated protocols High standard of clinical research Studies regarded expensive Studies performed rapidly and with high quality Low funding for investigator-initiated studies High compliance of patients Limited time and interest in clinical research English-speaking professionals Nordic cooperation has been or is presently being established within certain therapeutic areas (e.g. cancer) OPPORTUNITY THREAT Larger pool of patients (25 million inhabitants Legal obstacles (not allowing Nordic approval) vs. 5-9 mill/country)- faster recruitment or National, regional and opinion leader larger studies possible competition Differentiation (biopharmaceuticals, patient Too few new candidate drugs to keep phase I groups, therapeutic area, clinical phases etc.) clinics in several/all Nordic countries Improved, standardised procedures, incl. legal Lack of interest in Nordic cooperation if approvals (Competent Authorities, ethics) national funding is not established Nordic co-funding of non-commercial studies Pharma and biotech companies choose big Utilize Nordic key opinion leaders “preferred suppliers” Advantage for public health in Nordic countries Even fewer Nordic offices for CROs and big Advantage for Nordic medical research pharmaceutical companies (reduction is Advantage for CROs and sponsors wanting to already obvious) perform studies in Nordic countries