From the editor On the web...


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


Clinical Trials Insight Volume 1 2023


Editorial


Editor Peter Littlejohns peter.littlejohns@progressivemediainternational.com Sub-editor Ellys Woodhouse 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 © 2023


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.


SUBSCRIPTIONS Single issue price: UK £44 EU €68 US $89 RoW $89 One year: Two year:


Email: cs@progressivemediainternational.com


40–42 Hatton Garden, London, EC1N 8EB, UK. Tel: +44 20 7936 6400 Fax: +44 7724 9800


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


A learning curve T


he pandemic has been a learning curve in a plethora of ways. At the societal level, we had to adjust our way of living to stop the spread of Covid-19. At the level of industry and academia, the restrictions necessitated a shift from trials conducted at specialised sites, to remote management with investigational medicinal products (IMPs) shipped directly to participants’ homes. More than three years on since the start of the outbreak and most day-to-day lives have returned to normality. However, the movement towards fully decentralised or hybrid clinical trials represents a paradigm shift for the sector that will continue to endure.


Making the necessary adjustments throughout the supply chain to enable this change has not been easy. That’s why the lead article on page 18 looks at how supply chains have adapted to enable the transition from on-site to decentralised trials, with Andrea Valentino leading the discussion, hearing from several experts in academia and industry. Arguably the most important part of clinical trial logistics is getting IMPs to the correct location uncompromised, which is where temperature control comes into the equation. On page 32, Professor Temidayo Akenroye, a frequent BBC News interviewee on the topic of supply chain management, tells Jim Banks what considerations must be made when selecting active or passive containers when transporting IMPs, and how innovations in passive temperature control could make them more viable for transporting drug cargo. For trials attempting to establish an advantage over an existing drug, pitting the IMP against products that are already on the market is a necessity. As we learn on page 8 though, sourcing these comparator drugs isn’t always a straightforward process, especially when there are regulatory barriers to overcome in order to get them to the correct sites. Andrea Valentino speaks to two sourcing professionals to learn how comparator sourcing has changed with the move to decentralised trials, and how technology and collaboration could make it easier. Other topics covered in this issue include the value of blinding in clinical trials, how to select the appropriate central laboratory for a trial and the potential for AI to improve study recruitment and monitoring.


UK £67 EU €104 US $135 RoW $136 UK £105 EU €163 US $215 RoW $216


Peter Littlejohns, editor


For reprint, e-print and licensing enquiries Please contact: Media Licensing Co, The Grange, 3 Waverley Road, Farnham, Surrey, GU9 8BB. Tel: +44 203 773 9320 or email info@medialicensingco.com


Clinical Trials Insight / www.worldpharmaceuticals.net 3


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45