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Intralinks and CenterWatch presented “Crossing the Threshold: Clinical Portals from a Site Perspective" at DIA 2013.
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Copyright © Intralinks 2013 all rights reserved
Crossing the Threshold: Clinical Portals from a Site Perspective Joan Chambers Chief Operating Officer Kevin McNulty Director, Life Sciences Product Marketing Intralinks
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Copyright © Intralinks 2013 all rights reserved 2
• The views and opinions expressed in the following PowerPoint slides are those of the
individual presenter and should not be attributed to Drug Information Association, Inc.
(“DIA”), its directors, officers, employees, volunteers, members, chapters, councils,
Communities (formerly known as SIACs) or affiliates, or any organization with which the
presenter is employed or affiliated.
• These PowerPoint slides are the intellectual property of the individual presenter and are
protected under the copyright laws of the United States of America and other countries.
Used by permission. All rights reserved. Drug Information Association, Drug Information
Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are
the property of their respective owners.
Disclaimer
Copyright © Intralinks 2013 all rights reserved
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Agenda
Introductions • Joan Chambers, COO, CenterWatch • Kevin McNulty, Director, Life Sciences Product Marketing, Intralinks
Overview of Objectives and Key Findings
Data Findings from the Site’s Perspectives
Questions
Copyright © Intralinks 2013 all rights reserved 4
A Clinical Portal Defined
“An online gateway for study teams, sites, monitors, IRBs and others
involved in the planning and conduct of a clinical trial to access
all clinical systems data and resources in a secure, controlled,
and compliant manner.”
“A website that brings information together from diverse sources in
a uniform way.”
“A doorway, gate or other entrance.”
* Source: Webster’s Dictionary
Copyright © Intralinks 2013 all rights reserved 5
Overview of Objectives / Key Findings
Purpose Gain a better understanding of how investigative sites currently perceive clinical web portals.
Respondents N = 551, representing sites from North America, Europe, Asia Pacific and other regions; 58% = CRCs, 24% = Investigators
Key findings
• Overall, investigative sites manage a significant number of studies and collaborate with numerous organizations on each individual study
• Among those investigative sites that use clinical web portals, the majority access multiple clinical web portals across studies
• Among those investigative sites that use clinical web portals, the majority access multiple clinical web portals across studies
• The top benefits associated with clinical web portals are easier tracking of information, reduction in paper usage, and instant access to the most up-to-date information
Copyright © Intralinks 2013 all rights reserved 6
Overview of Objectives / Key Findings
Key findings
• Storage of investigator site files is either paper-based or combination of paper and electronic files • Electronic files easier for backup and disaster recovery • Collection of Sponsor/CRO documents
• Most investigative sites use 6 or more different logins/passwords to access online clinical systems across all of their research studies
• Types of information investigative sites most want to view when accessing a clinical web portal: • Query status, study/regulatory documents, training materials, study
announcements, study status and timelines, and patient recruitment information • Investigative sites place high importance on accessing web portals:
• Overall ease of use | Ease of navigation | Easy to find and well organized study documents
• 80% of respondents agreed that accessing a single web portal would be “Very to Extremely Valuable”
Copyright © Intralinks 2013 all rights reserved
Data Findings from the Site’s Perspectives
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Kevin McNulty Director, Life Sciences Product Marketing Intralinks
Copyright © Intralinks 2013 all rights reserved
Why a Clinical Portal Now?
• Increasingly global: Clinical trials are becoming more global and distributed in nature
• More people: The number of individuals involved in conducting a clinical research has increased
• More complicated workflow: Different requirements and regulations in different countries and regions, plus a trend towards outsourcing
• “Digitization” of data: New technology for collecting, accessing and managing clinical information
• Access demands: Mobile devices have made it easier to access information when you need it, where you need it
• Demand for simplification: Too many silo’ed systems, too many log-in IDs & passwords, redundancy, etc.
Copyright © Intralinks 2013 all rights reserved 9
Number of Clinical Studies Conducted on an Annual Basis
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Number of Organizations Typically Work with on a Single Clinical Study
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Type of Storage for Investigator Site Files
Half of respondents have a combination of paper and electronic files.
Copyright © Intralinks 2013 all rights reserved 12
Type of Information Requested Most Often from Sponsors/CROs
Answers to protocol inquiries is the most often requested information from sponsors/CROs.
Answers to study protocol inquiries
Update on CRF inquiries
Contact information
Technical support
Patient recruitment planning and support issues
Grant payment status updates
Update on AE/SAE inquiries
Other
83%
39%
36%
35%
34%
33%
29%
2%
Copyright © Intralinks 2013 all rights reserved 13
Information Most Want to Compare Across Sponsors
Patient enrollment timelines across sponsors, followed by study activation/start-up time are predominantly the two types of information respondents would most like to compare.
Patient enrollment timelines
Study activation/start-up time
Query turnaround times
Grant payments/other financial information
Patient retention rates
Other
59%
53%
47%
47%
32%
3%
Copyright © Intralinks 2013 all rights reserved 14
Number of Different Online Logins/Passwords to Access Online Clinical Systems
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Number of Different Online Clinical Systems Typically Accessed on a Single Clinical Study
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Number of Clinical Web Portals Accessed Across Studies
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Type of Information Most Likely to be Seen When Logging Into Clinical Web Portal
1% 7% 8%
13% 19%
22% 28% 28% 29%
38% 39% 40%
45% 45% 46%
51%
Other
Study close-out criteria
Contracts & budget changes/updates
Activation/study start-up status
Grant payment status or other financial information
Drug supply information
Milestones/due dates
Patient recruitment resources/tools/guidelines
Schedules (monitor visits/etc...)
Patient recruitment/enrollment
Study calendar/timeline
Study status
Study announcements/changes
Training documents
Study/regulatory documents
Query status The types of information most respondents would like to appear in a web portal include query status, study/regulatory documents, training documents, study changes, and study status.
Copyright © Intralinks 2013 all rights reserved
The most important attributes include
general ease of use, ease of navigation, and well-organized/easy to find study documents.
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Importance of Clinical Web Portal Attributes
14%
21%
26%
26%
38%
44%
46%
61%
63%
67%
68%
73%
Ability for patients to communicate in an online forum
Ability to communicate with other sites/peers
Ability to search on keywords within web portal on specific topics
Ability to access the web portal using tablet devices
Availability of comprehensive training program
Ability to print specific content from web portal
Relevant sponsor/CRO contact info easily found and readily available
Efficient uploading/downloading of study documents/patient files
Readily available technical support/customer service
Study documents are well-organized/easily found
Ease of navigation through web portal
General ease of use
Percent Rating 4 or "Very Important"
Copyright © Intralinks 2013 all rights reserved
5%
2%
6%
10%
18%
19%
20%
20%
24%
25%
38%
41%
50%
Other
It improves patient retention rates
It improves patient enrollment efficiency
Faster study start-up
It reduces the possibility of human error
It improves the response time from sponsor/CRO
It improves adherence to the study protocol
It reduces the amount of time I have to spend on study management
It reduces the number of systems I need to use when communicating with sponsors/CROs
Better overall collaboration with sponsors/CROs
I can get the most up-to-date information right away
It reduces the amount of paper we use
It is easier to keep track of information
The primary benefits associated with web
portals include easier tracking of information,
reduction in paper usage, and instant access to the
most up-to-date information.
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Primary Benefits of Using Clinical Web Portals
Copyright © Intralinks 2013 all rights reserved 20
Value of One Web Portal to Access Studies Across Multiple Sponsors/CROs
The majority of respondents agree that a single web portal with one login/password across multiple sponsors/CROs would be very valuable.
80% 17% 3%
10 = Extremely Valuable
Mean Rating = 8.7
1= Not at all Valuable
Copyright © Intralinks 2013 all rights reserved
Questions?
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Joan Chambers COO, CenterWatch [email protected] Kevin McNulty Director, Product Marketing, Intralinks [email protected]