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From the editor


A new era T


On the web...


Keep up with the latest developments in the pharmaceutical industry by visiting www.worldpharmaceuticals.net


Clinical Trials Insight Volume 1 2024


Editorial Editor Phoebe Galbraith


phoebe.galbraith@progressivemediainternational.com Sub-editor Pete Barden Group art director Henrik Williams Designer Martin Faulkner Production manager Dave Stanford Head of content Jake Sharp


Commercial Client services executive Derek Deschamps Sales manager Nathan Park


nathan.park@progressivemediainternational.com Managing director William Crocker


Clinical Trials Insight is published by Progressive Media International.


Registered in England No. 06212740. www.worldpharmaceuticals.net


ISSN 2050-3067 © 2024


All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying or otherwise, without prior permission of the publisher and copyright owner.


While every effort has been made to ensure the accuracy of the information in this publication, the publisher accepts no responsibility for errors or omissions. The products and services advertised are those of individual authors and are not necessarily endorsed by or connected with the publisher.


Subscription records are maintained at Progressive Media International.


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Printed by Stephens & George Print Group Images used under licence from Shutterstock.com


Phoebe Galbraith, editor


he clinical trials industry is evolving rapidly, driven by advancements in technology and the growing emphasis on patient-centric approaches. Innovations such as virtual trials, real-world evidence integration, and AI-driven analytics are reshaping how trials are conducted, making them more efficient and inclusive. Regulatory frameworks are adapting to accommodate these changes, fostering a more flexible environment for drug development. Collaboration between stakeholders, including pharmaceutical companies, CROs, and regulatory bodies, remains crucial in navigating complexities and ensuring the integrity and safety of clinical research outcomes in this dynamic landscape.


Designing clinical trials is a critical step, but traditional approaches are increasingly costly with low success rates in drug development. In our cover story, Monica Karpinski explores the potential of adaptive trial designs to help bridge this gap, speaking to Lilian Siu of the Princess Margaret Cancer Centre and Patrick Wen of the Dana-Farber Cancer Institute on how adaptive designs offer greater flexibility for a more efficient and ethical clinical trial on page 25. With clinical trial costs seeing a 140% increase over the past decade, it’s no wonder the industry is looking to optimise its supply sourcing to keep prices down. On page 22, we speak to Deloitte Life Sciences’ Dawn Anderson and EY’s Salman Shah to discuss how technology and data are helping cut costs while prioritising drug development. As the EU prepares to adopt CTIS next year, sponsors and regulators are gearing up for this transition. On page 8 we hear from Lene Grejs Peterson of Danish Medicines Agency and Inge Christoffer Olsen of Oslo University Hospital, who provide insights into the latest updates and challenges in implementing these new clinical regulations. As we delve into the latest research and development in the industry, I hope you enjoyed the latest edition of Clinical Trials Insight.


Clinical Trials Insight / www.worldpharmaceuticals.net


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