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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 to strengthen clinical research Objective to contribute to sustainable Nordic welfare Facts § An initiative from the Nordic Council

• f Ministries

§ Part of § Three year pilot project: 2013 – 2016 § Hosted by NordForsk § Funded by Nordic Council of Ministries and NordForsk

http://nta.nordforsk.org

SECRETARIAT

Project leader Pierre Lafolie MD, PhD, Karolinska Institutet, SE Project assistant Sandra Chesley Karolinska Institutet, SE Maria Nilsson Senior adviser, NordForsk NordForsk administration and economy Eivind Sætre/Tor Martin Nilsen Communications advisers Maria Skoog Clinical trials Coordinator The Copenhagen Trial Unit Copenhagen University Hospital, DK Christian Gluud Head of Department The Copenhagen Trial Unit Copenhagen University Hospital, DK Heli Pehrman Research Funding Director FinnMedi Oy, FIN Halla Sigrún Arnardóttir Project manager Clinical Research Center Landspitali University Hospital, IS Sven M. Carlsen Professor Department of Cancer Research and Molecular Medicine, NTNU, NO Steinar Aamdal Professor II Department of Oncology University of Oslo

WORK GROUP

Nordic Trial Alliance People

BOARD

Lars Køber Professor, Copenhagen Ralf w. Ackermann Medical Director, Novo Nordisk, Copenhagen Pauli Puolakkainen Professor, Helsinki Mia Bengtström Pharma Industry Finland Salvör Nordal Nordic Committee on Bioethics Iceland Kristjan Erlendsson, Special Advisor,Ministry of Welfare Iceland Sameline Grimsgaard Vice-Dean Research University of Tromsø Ole Alexander Opdalshei

• Ass. Secretary General

Norwegian Cancer Society, Oslo Christina Åkerman President ICHO, Boston (Chair) Mef Nilbert Professor, Lund

Nordic Trial Alliance network and some stakeholders

Small & medium enterprises, global industry Patients Public Researchers Hospitals Iceland

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
• vercome 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 SafetyAssisted reproductive technology (ART) and safety in the Nordic countries The project will use the CoNARTaS database to generate knowledge to

• ptimise 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

• f 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

• ngoing 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

• ther non-interventional studies

Small funds available for some actions during 2016 (meetings)

@nordforsk facebook.com/NordForsk

For more information: www.nta.nordforsk.org Contact: pierre.lafolie@ki.se nta@nordforsk.org

NTA want to extend a great THANK YOU to all contributors and participants!!

SWOT 2009 from Nordic Forum for Innovation in Health Care and Medicine on Challenges for Nordic Cooperation in Clinical Research

STRENGTH Excellent standard of authorities Excellent biobanks and registries High scientific standard of medical research High standard of clinical research Studies performed rapidly and with high quality High compliance of patients English-speaking professionals Nordic cooperation has been or is presently being established within certain therapeutic areas (e.g. cancer) OPPORTUNITY Larger pool of patients (25 million inhabitants

• vs. 5-9 mill/country)- faster recruitment or

larger studies possible Differentiation (biopharmaceuticals, patient groups, therapeutic area, clinical phases etc.) Improved, standardised procedures, incl. legal approvals (Competent Authorities, ethics) Nordic co-funding of non-commercial studies Utilize Nordic key opinion leaders Advantage for public health in Nordic countries Advantage for Nordic medical research Advantage for CROs and sponsors wanting to perform studies in Nordic countries WEAKNESS Small populations (and small markets) National approvals Ethics committees require translated protocols Studies regarded expensive Low funding for investigator-initiated studies Limited time and interest in clinical research THREAT Legal obstacles (not allowing Nordic approval) National, regional and opinion leader competition Too few new candidate drugs to keep phase I clinics in several/all Nordic countries Lack of interest in Nordic cooperation if national funding is not established Pharma and biotech companies choose big “preferred suppliers” Even fewer Nordic offices for CROs and big pharmaceutical companies (reduction is already obvious)

REFERENCES

Nordiskt samarbete om kliniska multicenterstudier. Prof. Bengt Fellström, Uppsala universitetssjukhus, för arbetsgruppen. 2011 NOS-M, “Present Status and Future Potential for Medical Research in the Nordic Countries, Nordic White Paper on Medical Research”, Academy of Finland, 2011 OECD, “Facilitating International Cooperation in Non-Commercial Clinical Trials”. OECD Global Science Forum. October 2011 ECRIN = European Clinical Research Infrastructure Network Stina Gestrelius, “Nordic Cooperation in Clinical Research- Opportunities and Challenges, Nordic Forum for Innovation in Health Care and Medicine, 2009-02-18 Norden ”A Study of Clinical Trials in a Nordic Arena”, Nordic Innovation Centre, 2010

What the NTA Implementation projects did

• WP 1 Research Ethics
• Work Package on Ethics

The project will analyse and propose on best practices in order to achieve a common research area with regard to ethical assessment of clinical Nordic clinical research. Project leader: Mika Scheinin, Finland Participating countries: Denmark, Finland, Iceland, Norway, Sweden Report A booklet describing the ethical review systems in all Nordic countries

• an evaluation of possible ways for a common Nordic ethical review

system

• the booklet will be published on NTA web

A large summit held in Helsinki October 2014

WP 2 Nordic Monitoring Network

• Work Package on Monitoring of Clinical Research

The aim of the project is to strengthen the collaboration between the Nordic GCP- units and to increase the quality of and facilitate the monitoring process of clinical research. Project leader: Annette Jørgensen, Denmark Participating countries: Denmark, Finland, Norway, Sweden Report Prepared guideline for a coordinated GCP-monitoring of clinical trials in the Nordic countries

• A common Nordic SOPs (standard operating procedures) for monitoring and

quality assurance in clinical research on NTA web

• http://nta.nordforsk.org/news/uideline-for-a-coordinated-gcp-monitoring-of-

clinical-trials-in-the-nordic-countries-published

WP 3 Transparency and registries of clinical data

• Work Package on Transparency and Registration

The project aims to improve registration and reporting of clinical studies, interventional and non interventional, by raising the homogeneity and quality of what is registered and reported for all studies. Project leader: Christian Gluud, Head of Department, Copenhagen Trial Unit, Centre for Clinical Intervention Research. Participating countries: Denmark, Finland, Iceland, Norway, Sweden Report

• Prepared a booklet publiced by Nordforsk on registries of clinical data

and transparency

• To be publiced at NTA web
• Also available at the book-table today!

WP 4 Collaboration between industry and academia

• Work Package on Collaboration between Industry and Academia

This project is part of creating a fundament for attracting more industry- initiated clinical drug trials to the Nordic countries and increasing the academic clinical trials. Project leader: Jussi Merikallio, Finland Participating countries: Denmark, Finland, Norway, Sweden Report

• Large meeting held in April 2015 in Helsinki
• Report on NTA web

http://nta.nordforsk.org/news/nordic-collaboration-in-clinical-research

Strategic initiative on Nordic Pediatric Clinical Research Network, NordicPedMed

• Work Package on Collaboration for a Nordic Pediatric research network

This project had initially gained interest in Norway and Finland. By a strategic grant it is now adopted also in Sweden, Iceland and Denmark Project leader: Kalle Hoppu and Pirkko Lepola, Finland Participating countries: Denmark, Finland, Norway, Sweden, Iceland Report

• Full report on NTA web
• http://nta.nordforsk.org/files/NTANordicinvestigatorsnetworkforPediatricMedicinesIReport_D0

9_31.03.2015_FINAL.pdf

For industry How to find Nordic Clinical Research Units Site listing Any Nordic site is welcome to register! Others

Direct link for industry Links to national one-stop-shop How to connect to ECRIN-ERIC resources List of useful links Cook-book for Nordic research

Webs not yet ready Jan 16