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Rbm Vs. Sdv: Pilot-Study Takeaways appliedclinicaltrialsonline.com Volume 27 Number 11 November 2018 YOUR PEER-REVIEWED GUIDE TO GLOBAL CLINICAL TRIALS MANAGEMENT 1992–2018 ACTAACCT 2626 e Year c of Servi RISK-BASED MONITORING RBM VS. SDV: PILOT-STUDY TAKEAWAYS TRIAL OVERSIGHT THE BASICS OF CENTRALIZED MONITORING WASHINGTON REPORT EU REPORT CLOSING THOUGHT FDA Initiatives Advance Tackling Disease in Europe: The Underlying Force in Orphan Therapies A Study in Contrasts Alzheimer’s Drug R&D FROM THE EDITOR Blockchain in Research, from Business to Personal pplied Clinical Trials has featured arti- In this outline, the patient becomes the owner of their data and Acles and discussion around the concept chooses where that data is stored and shared in the trusted blockchain of blockchain (bit.ly/2ANQtpD and bit. network. As the paper points out, the patient could seek out clinical ly/2SNPLzh). But it’s becoming a bit clearer that research opportunities or donate their data to research efforts. While blockchain is moving toward definitive uses CISCRP has conducted many studies on the altruistic reasons people quickly in the clinical trials world. participate in clinical trials—to help others benefit—this data donation At the recent CBI Interactive Response would surely take that step one further. Technologies (IRT) 2018 conference, Imran Hu-manity.co agrees that data ownership is fundamental, however, it LISA HENDERSON Shakur, senior manager, clinical supply capabil- also believes individuals should be paid for their data. I refer to this news Editor-in-Chief ities for Biogen, and Chad Sklodosky, director, blurb, bit.ly/2DnpiEo, and this longer article about one of the co-founders, digital clinical supply chain at Pfizer, presented on the topic “Leverage bit.ly/2zqlD4i. Hu-manity.co is partnering with IBM to use its blockchain Blockchain Technology to Enhance Supply Chain Management.” platform as its global consent ledger, whereby people will manage con- Sklodosky described a November 2017 blockchain workshop held at sent, authorization, and commercial use of their personal information. Pfizer’s Research Technology Center in Cambridge, where over 50 par- This information is not limited to medical, health, or research data, but is ticipants from various companies discussed 12 use cases, of which two definitely a part of co-founder and COO Michael DePalma’s larger posi- working groups were advanced. tion, as quoted in the referenced article. He also says in the article “there The one discussed at this conference was the Clinical Supply is a massive amount of valuable data being generated, but none of the Blockchain Working Group, whose long-term vision is to “develop a profits are being filtered back to the people who create the value.” fully interoperable, transparent, and auditable platform that enables In the business case use above, data ownership is not the question. investigational product (IP) to be tracked from point of manufacture to Those that consent into the private clinical supply chain process partici- the point of which it is consumed by the patient.” Sklodosky outlined the pate around the data flow. Interestingly, during Sklodosky’s presentation working group’s timeline around clinical supply, with the 2023 goal of he said that blockchain in this case could appear to be doing away with having fine-tuned a process that will be scalable to the ecosystem. IRT. However, he explained that IRT is actually blockchain “lite” and ex- The second use case that the group decided to advance was patient perts in IRT are needed to guide the forward solution. data donation and clinical research, which was not presented at this While the way data is collected and stored in this industry evolves from conference, but more can be learned from a recent paper issued by legacy to cloud-based systems; integration issues and actionable insights Deloitte and Pfizer (see bit.ly/2OnmVm8). around data, it’s the data itself that is moving into the center stage. EDITORIAL OFFICES SALES SUPPORT COORDINATOR Kristi Stevenson seal artwork at [email protected] 485 Route 1 South, Building F, Second Floor, +1 (732) 346-3006 fax: +1 (732) 596-0012, for more information. 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Digital-only editions will publish 6 times/year in Jan/Feb, April, May, July/Aug, Oct, and Nov. +1 (732) 346-3002. fax: +1 (732) 647-1235, ©2018 UBM. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording, or information storage and retrieval, without permission in writing from the publisher. Authorization to photocopy items for internal/educational or [email protected] personal use, or the internal/educational or personal use of specific clients is granted by UBM for libraries and other users registered with the Copyright Clearance Center, 222 Rosewood Dr. Danvers, MA 01923, 978-750-8400 fax 978-646-8700 or visit http://www.copyright.com online. For uses beyond those listed above, please direct your DIRECTOR OF ADVERTISING Wayne K. Blow written request to Permission Dept. fax 732-647-1104 or email: [email protected]. UK: +44 1244 629 304 fax: +44 1925 732 798, UBM Americas provides certain customer contact data (such as customers’ names, addresses, phone numbers, and e-mail addresses) to third parties who wish to pro- [email protected] mote relevant products, services, and other opportunities that may be of interest to you. If you do not want UBM Americas to make your contact information available to third parties for marketing purposes, simply call toll-free 866-529-2922 between the hours of 7:30 a.m. and 5 p.m. CST and a customer NATIONAL SALES MANAGER Bill Campbell service representative will assist you in removing your name from UBM Americas’ lists. Outside the U.S., please phone 218-740-6477. Applied Clinical Trials does not verify any claims or other information appearing in any of the advertisements contained in the +1 (847) 283-0129 fax: +1 (847) 282-1456, publication, and cannot take responsibility for any losses or other damages incurred by readers in reliance of such content. [email protected] To subscribe, call toll-free 888-527-7008. Outside the U.S. call 218-740-6477. 2 APPLIED CLINICAL TRIALS appliedclinicaltrialsonline.com November 2018 CONTENTS APPLIED CLINICAL TRIALS VOLUME 27, NUMBER 11 FEATURED 8 RBM Versus Source Data Verification Penelope Manasco, MD, Eric Herbel, Sean Bennett, MD, PhD, Michelle Pallas, Lisa Bedell, Deborah Thompson, Kevin Fielman, PhD, Garrett Manasco, Charlene Kimmel, Everett Lambeth, Lisa Danzig, MD Pilot study compares a risk-based monitoring and remote trial management method with traditional on-site SDV for trial oversight. GETTYIMAGES/IMAGE SOURCE PEER REVIEWED NEWS AND ANALYSIS COMMENTARY 14 The Basics of Clinical Trial 4 WASHINGTON REPORT A CLOSING THOUGHT Centralized Monitoring 5 EU REPORT 21 Closer Pharma-Diagnostic Adam Beauregard, Vadim Collaboration is Integral to Tantsyura, Fernand Labrie Alzheimer’s Drug R&D Examining the practicality of Edward I. Ginns, MD, PhD implementing CM techniques to drive trial oversight efficiency while saving on-site monitoring resources and costs. EDITORIAL ADVISORY BOARD Moe Alsumidaie Srini Dagalur, PhD Michael R. Hamrell, PhD, RAC Timothy Pratt, PhD, MBA Thought Leader and Expert in the Specialist Leader, Life Sciences President Senior Principal Medical Application of Business Analytics Technology Strategy MORIAH Consultants Research Manager Towards Clinical Trials and Healthcare Deloitte Huntington Beach, CA NAMSA New York, NY Parsippany, NJ Minneapolis, MN Erica J.
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