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 2021


Editorial


Editor Tim Gunn Managing editor Lucy Vann Sub-editor Phoebe Galbraith Group art director Henrik Williams Designer Martin Faulkner Production manager Dave Stanford Head of content Jake Sharp


Commercial Sales manager Nathan Park


nathan.park@progressivemediainternational.com Client services executive Derek Deschamps Managing director William Crocker


Clinical Trials Insight is published by Progressive Media International.


Registered in England No. 06212740.


John Carpenter House, John Carpenter Street, London, EC4Y 0AN, UK


www.ns-healthcare.com www.worldpharmaceuticals.net ISSN 2050-3067 © 2021


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.


SUBSCRIPTIONS Single issue price: UK £38 EU €59 US $78 RoW $78 One year: Two year:


Tel: +44 845 073 9607 (local rate) Fax: +44 207 458 4032


Email: cs@progressivemediainternational.com Progressive Media International, Riverbridge House, Ground Floor, South Tower, Anchor Boulevard. Crossways, Kent DA2 6SL


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


Patients first C


ovid-19 has impacted all of our lives and, with the Delta variant gaining traction worldwide, it seems to be something that we may have adapt to, with booster jabs on the agenda as well. As we look to the future, it is clear that there are lessons to be learned and a ‘new normal’ ahead, with words such as ‘agility’, ‘adaptability’ and ‘resilience’ often a key part of the conversation. For pharma and clinical trials, the landscape is ever-changing, but Covid-19 has undoubtedly brought about rapid change, such as the lightning fast development of vaccines and conducting studies while patients are locked down.


Patients are arguably one of the biggest stakeholders in the development of new drugs and, while not a new term, patient centricity is a growing movement. Clinical research centred around the patient might seem like an obvious choice, but challenges thrown up by the pandemic and advances in technology have highlighted that more can be done – and with benefits for the industry too.


Recruiting and then retaining patients in trials can be challenging, with heavy costs incurred for making replacements. Remote trials, with benefits such as the home delivery of medication and cutting travel, can reduce the burden on patients and, in turn, boost trial recruitment and retention. Changes in the set-up of trials and new technologies make patient centricity a running theme in this issue. On page 33, we look at decentralisation and the challenges of operating trials in a virtual setting, and how far this may go. As has been suggested for the future of conferences, will a hybrid model be the way ahead, offering the best of both worlds? Engaging patients in clinical trial design is another consideration on page 14, as it has the potential to help make studies patient, rather than product, centric. Increasing diversity in clinical trials also comes into play in our cover story on page 8. Having participants who closely mirror the intended patient population means successful studies are more likely to indicate that a new drug will effectively treat everyone with the particular disease or condition. Decentralised trials offer the opportunity to increase diversity, building sites around the participants – again, putting the patients first.


UK £58 EU €92 US $119 RoW $120 UK £93 EU €144 US $190 RoW $191


Lucy Vann, managing 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