Advisor 465

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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• Avoid introducing bias . Sponsors should not propose trial modifications based on data that may bias the interpretation of findings. Generally, for a blinded trial, modifications based on information that reveals the magnitude of the treatment efect or information presented by treatment arm have the potential to introduce bias, eg. stopping a trial before its planned duration based on knowledge of a treatment diference between arms from a previous interim analysis. Safeguards, such as a Data Monitoring Committee, may be introduced to safeguard data integrity and the guidance has several scenarios in which these principles are applied in the context of COVID-19. • Select appropriate participant data . When making trial modifications to address the impact of COVID-19, sponsors should focus on summaries of participant-specific data, such as missing data, treatment discontinuation, treatment interruptions, trial withdrawal and endpoints. Non-participant- specific information, such as information on site closures and the disruption of the supply of investigational product, may also be appropriate to use when considering modifications to the trial. Trial mitigation and analysis To address the impact of COVID-19 on evaluating primary and key secondary trial endpoints, the FDA outlines several design and analysis strategies and notes that multiple strategies may be needed to address the impact of COVID-19 adequately. Source: Webinar recording now available Does your Trial Master File meet the key requirements? A series of self-checklist questions about the sponsor’s Trial Master File – both paper and electronic – as based on EMA TMF guidelines and inspection advice. For this and other webinar recordings visit the website and click ‘Webinars’ www.brookwood-global.com

Principal Author & Editor: Prof David Hutchinson Senior Contributor: Jane Baguley Production Editor/Writer: Sharon Jordan Senior Correspondents: Fabio Camarri, Mark Elsley, Hideki Fujiwara, Lisbeth Tofte Hemmingsen, Peter Marks, Stuart McCully, ColinWilsher Aim To provide news and information to allow clinical research and quality assurance professionals, trainers, regulators, academics and members of ethics committees to stay up to date with clinical research and good practice developments. Scope Executive summaries of key laws and guidelines relating to clinical research in the ICH regions. Summaries of relevant articles and information in other publications, press releases and information on the Internet. Information on: • changes in regulations, codes of practice, guidelines and new clinical research procedures • news from important meetings and conferences • ICH developments and progress • news, views and opinions about ICH GCP implementation • solutions to compliance-related problems • inspection findings and lessons to be learnt • clinical research methodology, statistical and legal issues • quality assurance issues and procedures • self- and independent audit practice • training courses, jobs and other opportunities. Sources of information • We gather news from correspondents and other sources around the world. • We gather intelligence from those actively involved in the regulatory process. • We review the major medical, clinical research and QA journals. • We search the web and regularly visit the websites of the major regulatory authorities in Europe, the USA and Japan, pharmaceutical industry and professional associations, major academic organisations and health associations. • Sources of information, current at the time of publication, are usually quoted at the end of each article. Published by: Brookwood Global (Canary Ltd), 5 Studley Court Mews, Chobham, Surrey GU24 8EB, UK Telephone: +44 1483 811383; Fax: +44 1483 812163 Email: info@brookwood-global.com; website © Canary Ltd 2020 All rights reserved. No part of this publication may be copied, transmitted, reproduced in any way without the written permission of the publisher. Disclaimer: Whilst we try to ensure that information published is correct, the Editors, Advisors or publishers accept no liability for losses or damages arising. You should always seek a second opinion before acting on any information provided.

Design: LIMA Graphics, Fleet, Hampshire, UK Print: Surrey Litho, Great Bookham, Surrey, UK

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Issue 465, 2020

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