Crossing the Threshold: Clinical Portals from a Site Perspective
Upcoming SlideShare
Loading in...5
×

Like this? Share it with your network

Share

Crossing the Threshold: Clinical Portals from a Site Perspective

  • 844 views
Uploaded on

Intralinks and CenterWatch presented “Crossing the Threshold: Clinical Portals from a Site Perspective" at DIA 2013.

Intralinks and CenterWatch presented “Crossing the Threshold: Clinical Portals from a Site Perspective" at DIA 2013.

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
844
On Slideshare
843
From Embeds
1
Number of Embeds
1

Actions

Shares
Downloads
9
Comments
0
Likes
0

Embeds 1

https://twitter.com 1

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 1. 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 1
  • 2. 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
  • 3. Copyright © Intralinks 2013 all rights reserved 1 2 3 4 3 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
  • 4. 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
  • 5. 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
  • 6. 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”
  • 7. Copyright © Intralinks 2013 all rights reserved Data Findings from the Site’s Perspectives 7 Kevin McNulty Director, Life Sciences Product Marketing Intralinks
  • 8. 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.
  • 9. Copyright © Intralinks 2013 all rights reserved 9 Number of Clinical Studies Conducted on an Annual Basis
  • 10. Copyright © Intralinks 2013 all rights reserved 10 Number of Organizations Typically Work with on a Single Clinical Study
  • 11. Copyright © Intralinks 2013 all rights reserved 11 Type of Storage for Investigator Site Files Half of respondents have a combination of paper and electronic files.
  • 12. 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%
  • 13. 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%
  • 14. Copyright © Intralinks 2013 all rights reserved 14 Number of Different Online Logins/Passwords to Access Online Clinical Systems
  • 15. Copyright © Intralinks 2013 all rights reserved 15 Number of Different Online Clinical Systems Typically Accessed on a Single Clinical Study
  • 16. Copyright © Intralinks 2013 all rights reserved 16 Number of Clinical Web Portals Accessed Across Studies
  • 17. Copyright © Intralinks 2013 all rights reserved 17 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.
  • 18. 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. 18 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"
  • 19. 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. 19 Primary Benefits of Using Clinical Web Portals
  • 20. 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
  • 21. Copyright © Intralinks 2013 all rights reserved Questions? 21 Joan Chambers COO, CenterWatch Joan.chambers@centerwatch.com Kevin McNulty Director, Product Marketing, Intralinks kmcnulty@intralinks.com