Issue 7 – May 2016

UK EORTC LIAISON OFFICE

By Liz Flackett1, Karen Heasley2 – EORTC Liaison Officers and EORTC HQ team3
1NIHR CRN: Cancer, University of Leeds, UK; 2CR-UK, Angel Building, London, UK;
3EORTC HQ International Policy & Communication Offices, Brussels, BE

Table of content

UK EORTC Liaison offices activity since Oct 2015

Leeds Liaison Office update

The Leeds Liaison Office continues to play a major role in opening EORTC member studies in the UK and fully supports UK investigators throughout the process.

  • New studies opened!
    Since the September 2015 newsletter, the Liaison Office has opened 5 new EORTC studies across the UK: 1203, 1208, 1217, 1320 and 75111-10114. These studies investigate Stomach, Melanoma, Lung, Brain and Breast cancers and are all included in the NIHR Clinical Research Network Portfolio of high-quality research studies in England. These are detailed in the recruitment status table below.

  • Participant Information Improvement project
    The Liaison Office and NCRI Consumer Forum reference panel continue to work successfully together to review and improve EORTC Participant Information Sheets given to people in the UK participating in EORTC studies. Since the last newsletter, the Liaison Office also worked with an independent UK body: the Paediatric Oncology Reference Team (PORT) comprising parents who have direct experience of children’s cancer, to ensure that new PIS ICs for the CREATE study were suitable for children in the UK choosing to participate.

  • Patient/public/carer involvement in the review of EORTC trials concepts
    Based on the positive experience of participant information review, EORTC has started a new pilot that involves patients/public/carers at a much earlier stage in the trial development process. Volunteers will be asked to provide comments on EORTC trial concepts in order to shape the final trial design. Evaluation of this experience will be performed after the first few concept reviews.

    Thank you to all our volunteers!

  • New research approval system in England: HRA approval
    HRA approval aims to simplify and improve the approvals process for research in England by removing duplicate application routes. The new system was implemented across all research study types on 1st April 2016. Since the last newsletter the Liaison Office has been looking at the implications of the new system for EORTC studies opening in the UK and will submit all new EORTC member studies (with a CI in England) via this process.

London Liaison Office update

  • New Collaboration Pathways have been developed to address the lack of a single efficient mechanism to explore UK clinical trial collaboration with the EORTC and vice-versa. They provide a high level overview of the key steps involved in determining whether EORTC/UK collaboration is viable, with the aim of obtaining a more timely response. Alongside the pathways a confidentiality framework has been developed to protect against the sharing of study information outside of the collaboration discussions. This framework forms the basis of a “conditions of use” agreement associated with utilising the Collaboration Pathways the details of which are sent on a study-by-study basis.

    Link out for further info:

    For further details please contact EORTC Liaison Officer: Karen.Heasley@cancerresearch.org.uk.
    Map for exploring UK Collaboration.
    Map for exploring EORTC Collaboration.

  • International collaboration interest between the EORTC and UK continues with a total of 45 notifications received by the London EORTC Liaison Officer since March 2014 and April 2016. Of the 45 studies, four are currently being taken forward to formal collaboration between the EORTC and a UK Research Group. The range of tumour types associated with collaboration interest approaches is highlighted in the graph below indicating that the most frequent collaboration interest is associated with Lung and Head & Neck & Thyroid tumours, although interest from a broad range of tumour types can be seen.

Tumor Types associated with collaboration Interest Martch 2014 - april 2016

EORTC trials portfolio and recruitment status in the UK

List of studies under activation, recruiting or recently closed in the UK
(cut-off date: 02/05/2016)

International Rare Cancer Initiative (IRCI) – trials recruitment status

IRCI is a joint initiative established between Cancer Research UK (CRUK), the National Institute of Health Research Clinical Research Network: Cancer (NIHR CRN: Cancer), the National Cancer Institute (NCI), the European Organisation for Research and Treatment of Cancer (EORTC), the Institut National Du Cancer (INCa) and the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG).

The aim of this initiative is to facilitate the development of international clinical trials for patients with rare cancers in order to boost the progress of new treatments for these patients.

IRCI has 7 trials in its portfolio:

  1. BALLAD (UK led), EORTC not involved.
  2. HGUS (EORTC led)
  3. uLMS (US led)
  4. Salivary Gland (EORTC led)
  5. InPACT (UK led) (EORTC provides operational support)
  6. InterAAct (UK led)
  7. Uveal Melanoma (US led). This has finished recruiting (to interim stage only).

 

What type of assistance is provided by UK Liaison Offices?

Leeds Liaison Office (LO) – EORTC led studies regulatory support

The Leeds LO is the national contact point for UK investigators to provide guidance, practical information and assistance on all aspects of participation to EORTC studies. It mediates the collaboration and communication with EORTC HQs staff in charge of the study.

The Leeds Liaison Officer performs regulatory submissions to the HRA and REC via IRAS and any other regulatory requirements such as ARSAC, in collaboration with CI team and EORTC HQ. The LO, together with the CI verifies the quality of the translation of essential documents such as PIS-IC and protocol summary, and adapts the PIS-IC to UK requirements in collaboration with a dedicated volunteer patient/public panel from the NCRI Consumer Forum. The Leeds LO may assist UK sites in negotiations of contracts and may provide guidance to new young UK investigators how to set-up the EORTC trials at their site.

London Liaison Office – UK led studies & new research projects collaborations initiatives

London Liaison Officer is the main contact for UK CSGs and CTUs searching for collaboration with EORTC. London LO:

Support to the investigators willing to apply for EORTC membership

EORTC membership enables the active participation in EORTC clinical trials and EORTC groups’ meetings, conferences and trainings. Candidates may apply directly through the Membership Committee (membership@eortc.be), or through the structures of the research groups (chairman or secretary).

The related information you can find here. The application forms are available from the EORTC Membership Coordinator (Ms Teodora Kirova) who should be contacted via general e-mail: membership@eortc.be.

Career opportunities for young investigators (physicians and statisticians)

EORTC always looks for young, active, talented people, who want to develop their skills under the supervision of EORTC. There are different opportunities available, the grants for 1 up to 3 years, when young people can design, construct and analyze different kind of data with the possibility to produce the final professional paper for publication or presentation at one of the world-famous scientific congresses. Everybody interested in the fellowship position at EORTC HQ is welcome.

http://www.eortc.org/careers/

Agenda of Events

Full calendar of EORTC scientific meetings, conferences and trainings per category can be found here.

For direct access to information on EORTC Reserach group meetings calendar click here.

SAVE the DATE!

We highly recommend the following key conferences:

Navigating Safely through the Regulatory Triangle: Clinical Trials – In vitro Diagnostics – Data Protection
Venue: Brussels, Belgium (07/09/2016)

Legislative frameworks have been developed in silos, and the needs of clinical research and even its very nature is poorly understood. Legislations focus on either healthcare or commercialization of a product and not on the required research. In the last two years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, yet the silo approach makes the overall framework inconsistent and potentially damaging to EU capacity to make rapid progress in the field of precision medicines.

This conference will explore the interface between the Clinical Trial Regulation, expected to be applicable in 2017-2018, and the In vitro Diagnostics and Data Protection regulations now being discussed by the EU Parliament and Council.

More detailed information about Navigating Safely through the Regulatory Triangle can be found here.

Innovation and Biomarkers in Cancer Drug Development (IBCD)
Venue: Brussels, Belgium (08/09/2016 – 09/09/2016)

Without a doubt, the combined efforts of the EORTC, an academic research organization, the US National Cancer Institute, a governmental institution, the European Medicines Agency, a regulatory agency, and the American Association for Cancer Research, a professional scientific association, assure that a unique program focusing on multi-stakeholder approaches to cancer drug development will result. They are assembling a rich scientific program for IBCD 2016 that covers topics of interest to all cancer drug development stakeholders.
More detailed information about IBCD conferencecan be found here.

28th EORTC-NCI-AACR Symposium on “Molecular Targets and Cancer Therapeutics”
Venue: Munich, Germany (29/11/2016 – 02/12/2016)

It is our great pleasure to announce that the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics will take place in Munich. Hosted by the European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR), the 2016 Symposium will bring together around 2000 academics, scientists and pharmaceutical industry representatives from across the globe to discuss innovations in drug development, target selection and the impact of new discoveries in molecular biology.

Building on the success and focus of previous highly acclaimed symposiums, this drug development and translational research meeting, focussing on preclinical and phase I studies , will enable delegates to have in-depth scientific discussions on the latest developments in targets and drugs.

More information on ENA 2016 website

EORTC Groups Annual Meeting (EGAM)
Venue: Brussels, Belgium (09/03/2017 – 10/03/2017)

More information will be available in the future here.

Our contact details are can be found on EORTC UK Liaison Office home page

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