Advisor 469

CLINICAL RESEARCH • CLINICAL QUALITY ASSURANCE

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u Further data integrity issues were associated with the way in which the VAS data were collected and handled: • the audit trail of the tablet only captured the results once all three VAS assessments at the visit had been completed • the patient could change their score at any point until the finish button was pressed on the final confirmation screen; any changes before this were not recorded in the audit trail • the tablet displayed the numerical value of the point at which the patient marked their score and could be changed, therefore potentially biasing the scaled assessment • the final scores used to measure the primary outcome were calculated from the raw data by the sponsor’s statistics department, and these scores were not given to the site New EU framework to ensure ‘preparedness’ of paediatric trials The European Medicines Agency (EMA) has released the final version of a framework for paediatric clinical trial preparedness. The 22-page document (dated 31 August 2020) provides guidance on the principles of good preparation, and approaches to preparing plans and trials. The document defines trial preparedness as “a structured assessment of the key factors that could increase the likelihood of a smooth and timely course of a paediatric clinical trial, integrating information from multiple stakeholders on what is possible within individual studies and therefore also for the overall drug development plan”. The document argues that paediatric trials are a special case. Paediatric drug development plans and individual clinical trials can be difficult to perform for many reasons, and the number of eligible paediatric patients is often limited. As a result, timely trial completion is often difficult and paying particular attention to study design is critical. Trial conduct is often improved iteratively, and the perspectives of participants, parents/carers and patient advocacy groups can make significant contributions to optimising trial design, increasing patient retention, and reducing protocol amendments, delays and further expenses. However, such perspectives are not always included at the planning stage. The framework document notes that the research community needs to • develop strategies to improve site selection and management • tackle critical trial practicalities such as the location of sites and traveling costs • disseminate good practice • promote transparency about results and preparation. Source: when the data were returned to them. Source:

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 © Brookwood Global 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.

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Issue 469, 2020

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