1763P - The challenge for Cancer Trials Ireland (CTI) to sponsor NCI and non-EU sponsored trials in the EU

Background

The environment for academic clinical trials has become more challenging in the EU and beyond. There are a number of factors contributing, in particular the regulatory challenges. While Ireland and Northern Ireland governments signed an MOU with the US NCI Director in March 2021, solidifying a 25-year arrangement where Ireland and Northern Ireland is considered an NCI site and Irish hospitals are registered and Irish investigators are registered with CTEP, the practicalities of groups like CTI sponsoring NCI trials outside of the US are onerous.

Methods

Gathering experiences from our international partners (EORTC (EU), ANZUP (Australia) and BIG) where significant issues are reported in setting up NCI or other US-sponsored trials. The common thread is the lack of “regulatory harmony” in running international academic clinical trials in the EU with a non-EU sponsor.

Results

Approaches to GDPR in clinical trials are not aligned between the EU and non-EU. The experience of the Groups interviewed is that Standard Contractual Clause with regard to data transfer is a stumbling block. When working with the NCI, the OHRP are also involved and there are clear standards to follow as NCI trials are federally sponsored and funded. The Federalwide Assurance (FWA) is the only type of assurance currently accepted and approved by OHRP. Cancer Trials Ireland and other collaborative groups must have this in place in order to sponsor NCI trials outside of the US.

Conclusions

Public funding is not utilized to its optimal level in multinational academic trials. Propose greater collaboration at government level and mutual recognition agreements with regard to GDPR in clinical trials.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Cancer Trials Ireland.

Funding

Has not received any funding.

Disclosure

O. McLoughlin: Financial Interests, Institutional, Full or part-time Employment: Cancer Trials Ireland. S. O'Reilly: Financial Interests, Personal, Other, data monitoring committee membership: AstraZeneca; Financial Interests, Personal, Other, travel expenses: Roche; Financial Interests, Personal, Other, travel: Novartis, Nordic pharma; Financial Interests, Personal, Advisory Board, ad board: Merck; Financial Interests, Personal and Institutional, Other, funding for educational meetings: Roche; Non-Financial Interests, Member of Board of Directors, member executive board: breast international group; Non-Financial Interests, Advisory Role, advisory board member: Irish cancer society; Non-Financial Interests, Leadership Role, clinical lead: cancer trials Ireland; Non-Financial Interests, Member of Board of Directors: cork arc cancer support house; Non-Financial Interests, Other, advisory board member: national cancer registry. M. Morris: Financial Interests, Institutional, Trial Chair, assumed role of Trial Management Group Chair for a single centre investigator led trial partly funded in part by Bayer: Bayer. M. Lawler: Financial Interests, Personal, Invited Speaker, Honoraria for presentations unrelated to the current publication: Bayer, EMD Serono, Novartis, Pfizer, Roche; Financial Interests, Personal, Writing Engagement, Honoraria for developing report unrelated to the current publication: Carnall Farrar. I.D. Davis: Financial Interests, Personal, Full or part-time Employment, Professor of Medicine and Head of Eastern Health Clinical School: Monash University; Financial Interests, Personal, Full or part-time Employment, Professor of Medicine; Head, Eastern Health Clinical School; medical oncologist: Eastern Health; Financial Interests, Personal, Royalties, Authorship royalties for: Health Press; Financial Interests, Personal, Other, Remuneration for associate editor role in Therapeutic Advances in Medical Oncology: SAGE; Financial Interests, Institutional, Local PI, Institutional support for clinical research: Movember Foundation, Merck/MSD, Bristol Myers Squibb, Exelixis, Astellas, Pfizer, AstraZeneca, Roche / Genentech, Eisai, Bayer, Janssen, Ipsen, Seagen; Non-Financial Interests, Member of Board of Directors, Director and Chair: ANZUP Cancer Trials Group; Non-Financial Interests, Advisory Role, All honoraria and payments are made directly to ANZUP Cancer Trials Group with no pass-through payment: Roche, Eisai, Pio Therapeutics, Xennials Therapeutics, Telix Therapeutics; Non-Financial Interests, Member: ASCO, Clinical Oncology Society of Australia, Medical Oncology Group of Australia, American Association for Cancer Research, Australian Academy of Health and Medical Sciences; Non-Financial Interests, Other, Member of Council: Clinical Oncology Society of Australia. D.A. Lacombe: Financial Interests, Institutional, Other, Support to the EORTC for a study/research project: Adastra Pharmaceuticals, Inc., Alliance Boots, Amgen Limited, Astellas Pharma, Astellas Pharma Co. Ltd, AstraZeneca UK Limited, Bayer Healthcare Pharmaceuticals Inc., Bluefish Pharmaceutical AB, Boehringer Ingelheim, Boehringer Ingelheim Limited, Bristol-Meyers Squibb Belgium NV/SA, Bristol-Meyers Squibb International Corporation, Celgene, Debiopharm S.A., Eli Lilly and Company Limited, Exelixis, F. Hoffmann-La Roche AG (Basel), Ferring Laegemidler A/S, Foundation for the National Intitutes of Health, Fresenius Kabi Deutschland GmbH, GSK Research & Development Limited, Helsinn Healthcare SA, Immunomedics Europe, Kyowa Kirin Services Ltd, Innate Pharma, Janssen Pharmaceutica N. V., Janssen Research & Development, Menarini Richerche S.p.A, Merck & Co., Inc., Merck KGaA, Merck Sharp & Dohme, MIRATI Therapeutics, MSD Merck Sharp and Dohme AG, N. V. Pfizer S.A., Novartis Pharma AG, NV Sanofi Belgium SA, Pfizer Inc., Rivopharm Limited, Pfizer PIO, Pierre Fabre SA, Recordati Rare Diseases Sarl, S.A. Amgen N.V., Sanofi-Aventis Research & Development, Seacross Pharma (Europe) Limited, Sun Pharma Global FZE, Takeda Oncology Company - Millennium, Tesaro; Financial Interests, Institutional, Other, Support to the EORTC for study/research project: Bristol-Meyers Squibb GmbH & Co. KGaA; Financial Interests, Institutional, Other, Support to EORTC for a study/research project: Merck Sharp & Dohme Corp; Non-Financial Interests, Member of Board of Directors, membership role, voting member: European Medicines Agency. T. Goulioti: Financial Interests, Personal, Full or part-time Employment, CEO: Breast International Group aisbl; Financial Interests, Institutional, Royalties, My institution receives royalties from Agendia for MammaPrint, due to the collaboration on the conduct of the MINDACT trial: Agendia; Financial Interests, Institutional, Funding, BIG (my institution) receives funding from AZ for the conduct of the OlympiA trial: AstraZeneca; Financial Interests, Institutional, Funding, BIG receives funding for the conduct of the APHINITY, LORELEI and IMpassion 030/ALEXANDRA trials: Roche/Genentech; Financial Interests, Institutional, Funding, BIG receives funding for the conduct of the BRAVO trial: Tesaro/GSK; Financial Interests, Institutional, Funding, BIG receives funding for the conduct of the ALPHABET and (Neo)ALTTO trials: Novartis; Financial Interests, Institutional, Funding, BIG received/receives funding for the conduct of the PALLAS and PYTHIA trials: Pfizer; Financial Interests, Institutional, Funding, BIG receives funding for the conduct of the AMEERA-6 trial: Sanofi/Aventis; Financial Interests, Institutional, Funding, BIG received funding for the conduct of the FINESSE trial: Servier; Financial Interests, Institutional, Funding, Biovica contribute with a small grant to the PYTHIA trial: Biovica; Non-Financial Interests, Institutional, Proprietary Information: All the companies mentioned in the financial interests section also provide access to proprietary information linked to the drugs used for the studies; Non-Financial Interests, Member: ASCO. All other authors have declared no conflicts of interest.