crossing the threshold: clinical portals from a site perspective

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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 1

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

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Page 1: Crossing the Threshold: Clinical Portals from a Site Perspective

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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Page 2: Crossing the Threshold: Clinical Portals from a Site Perspective

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

Page 3: Crossing the Threshold: Clinical Portals from a Site Perspective

Copyright © Intralinks 2013 all rights reserved

1 2 3 4

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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

Page 4: Crossing the Threshold: Clinical Portals from a Site Perspective

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

Page 5: Crossing the Threshold: Clinical Portals from a Site Perspective

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

Page 6: Crossing the Threshold: Clinical Portals from a Site Perspective

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”

Page 7: Crossing the Threshold: Clinical Portals from a Site Perspective

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

Page 8: Crossing the Threshold: Clinical Portals from a Site Perspective

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.

Page 9: Crossing the Threshold: Clinical Portals from a Site Perspective

Copyright © Intralinks 2013 all rights reserved 9

Number of Clinical Studies Conducted on an Annual Basis

Page 10: Crossing the Threshold: Clinical Portals from a Site Perspective

Copyright © Intralinks 2013 all rights reserved 10

Number of Organizations Typically Work with on a Single Clinical Study

Page 11: Crossing the Threshold: Clinical Portals from a Site Perspective

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.

Page 12: Crossing the Threshold: Clinical Portals from a Site Perspective

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%

Page 13: Crossing the Threshold: Clinical Portals from a Site Perspective

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%

Page 14: Crossing the Threshold: Clinical Portals from a Site Perspective

Copyright © Intralinks 2013 all rights reserved 14

Number of Different Online Logins/Passwords to Access Online Clinical Systems

Page 15: Crossing the Threshold: Clinical Portals from a Site Perspective

Copyright © Intralinks 2013 all rights reserved 15

Number of Different Online Clinical Systems Typically Accessed on a Single Clinical Study

Page 16: Crossing the Threshold: Clinical Portals from a Site Perspective

Copyright © Intralinks 2013 all rights reserved 16

Number of Clinical Web Portals Accessed Across Studies

Page 17: Crossing the Threshold: Clinical Portals from a Site Perspective

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.

Page 18: Crossing the Threshold: Clinical Portals from a Site Perspective

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"

Page 19: Crossing the Threshold: Clinical Portals from a Site Perspective

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

Page 20: Crossing the Threshold: Clinical Portals from a Site Perspective

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

Page 21: Crossing the Threshold: Clinical Portals from a Site Perspective

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]