investigative site perspective on clinical web portals

{Date}

1

Inves&ga&ve Site Perspec&ve on Clinical Web Portals

{Company}

Slide #

Business Objec7ves 3

Survey Methodology 5

Execu7ve Summary 6

Clinical Study Document Management 12

Paper-‐Based Methods 27

Online Tools 34

{Company} Specific Results 44

Respondent Profile 59

2

Table of Contents

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•  Objec7ves of the study were: – Determining what methods are currently being used for clinical study document exchange, iden7fying any trends in the usage of these methods year on year and evalua7ng the efficacy of these methods.

– Gathering insights with regard to the use of an online tool for site feasibility surveys, as well as gauging the level of interest in an online tool to complete these types of surveys.

– Among inves7ga7ve sites who have used or are currently using the {company’s} system, determining the efficacy of this online system.

Business Objec7ves

Phase I Phase II

Survey conducted online in {Month / Year} {Month / Year}

Number of clinical research professionals emailed worldwide

{number} {number}

Final sample size {number} {number}

Final sample composi7on

25% Inves7gators 58% CRCs 6% Regulatory Coordinators 6% Administrators

23% Inves7gators 58% CRCs 4% Regulatory Coordinators 6% Administrators

Country of origin 70% North America 21% Europe 7% Asia Pacific

71% North America 19% Europe 5% Asia Pacific

4

Survey Methodology

5

GENERAL FINDINGS:

•  While the clinical research coordinator con7nues to be the primary contact in terms of communica7ng with and exchanging documenta7on with the sponsor/CRO, the Regulatory Coordinator’s role as a primary contact appears to be growing: –  The propor7on of respondents who selected the Regulatory Coordinator as the primary contact

increased significantly in Survey II.

•  The predominant primary method of clinical document exchange con7nues to be email: –  A significantly higher propor7on of respondents reported using email as their primary method in

Survey II (from X% in Survey I to % in Survey II). Declines, albeit not significant, were evident in other methods of document exchange including fax, courier and online tools (online tools from X% in Survey I to X% in Survey II).

•  Of all document exchange methods, email is used X% of the 7me on average. This is followed closely by online tools, which are used X% of the 7me on average.

•  Close to half of respondents report using more than X logins/passwords to access web-‐based clinical systems.

Execu7ve Summary

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Execu7ve Summary PAPER-‐BASED METHODS:

•  Similar to Survey I findings, most sites value paper-‐based document exchange methods for the paper trail of study documenta7on, ease of use and general simplicity.

•  However, paper-‐based methods con7nue to be associated with a waste of paper, taking up too much storage space and generally 7me-‐consuming (in terms of storing / tracking / resending documents): –  Well over half of respondents report spending a minimum of 2 hours

searching for documents on a weekly basis. –  And more than half of respondents con7nue to resend clinical documents to

the sponsor/CRO and vice versa. •  Document due date tracking con7nues to be performed

manually or using office electronic tools.

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Execu7ve Summary ONLINE TOOLS:

•  Although it is s7ll not the primary method of document exchange, the general use of online tools for study document exchange is increasing: –  A significantly higher propor7on of respondents report having used an online tool in

Survey II (from X% last year to X% this year). •  Among those sites with experience with online tools, most have used EDC

and clinical portals. •  The primary benefits associated with online tools remain the same: the

reduc7on in paper waste, the ability to immediately access the most up-‐to-‐date informa7on, as well as the ability to easily keep track of informa7on.

•  Online tools are mostly being used for the comple7on and exchange of Case Report Forms, this is followed by the comple7on of site feasibility surveys, study ini7a7on ac7vi7es (i.e. training and delivery of study-‐related materials) and communica7on regarding regulatory updates.

CLINICAL STUDY DOCUMENT MANAGEMENT

General Analysis

8

5% 5%

13% 5%

1%

2%

5% 15%

65% 59%

3% 4%

7% 10%

0%

20%

40%

60%

80%

100%

SURVEY I SURVEY II

Principal Inves7gator

Subinves7gator

Clinical Research Coordinator

Regulatory Coordinator

Contract Manager

Administrator

Other

Don't Know

9

Clinical Document Exchange: Primary Point of Contact

While the clinical research coordinator s/ll primarily handles the clinical document exchange process with sponsors/CROs, the Regulatory Coordinator plays a bigger role as the primary point of contact as well.

A 1

B 2

C 3

Sta7s7cally significant at 95%: 1 > A; 2 > B; 3 > C

(n=XXX) (n=XXX)

3% 2% 5% 3%

12% 12%

22% 24%

27% 22%

11% 13%

20% 25%

0%

20%

40%

60%

80%

100%

SURVEY I SURVEY II

More than 15

11 to 15

6 to 10

3 to 5

1 to 2

None

Don't Know

10

Number of Site Feasibility Surveys on an Annual Basis A significantly higher

number of respondents this year completed more than 15 site feasibility surveys on an annual basis.

A 1

B 2

Sta7s7cally significant at 95%: 1 > A; 2 > B (n=XXX) (n=XXX)

4% 3%

12% 10%

18% 15%

27% 29%

25% 31%

14% 13%

0%

20%

40%

60%

80%

100%

Survey I Survey II

100%

76% to 99%

51% to 75%

26% to 50%

1% to 25%

0%

11

Propor&on of Studies where CRO is Involved Inves/ga/ve sites con/nue to work directly with CROs on behalf of sponsors most of the /me.

A 1

Sta7s7cally significant at 95%: 1 > A (n=xxx) (n=xxx)

4% 6% 9%

4% 3%

72%

61% 58% 59%

78%

3% 8%

14% 12%

5%

18% 24%

14%

24%

11%

0%

20%

40%

60%

80%

100%

Puplic/Private Hospital

Univ. Hospital/AMC Ind. Prac7ce Group Prac7ce Research Center

Fax Email Courier Online web-‐based tool

12

**Organiza/ons with sufficient sample sizes

Percent Responding**

Similar to Survey I findings, email is the predominant primary method of clinical study document exchange across organiza/ons.

Primary Method Usage by Organiza&on

Sta7s7cally significant at 95%: None

(n=xxx)

PAPER-‐BASED METHODS General Analysis

13

Time Spent Searching for Documents

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35%

42%

16%

5%

3%

34%

45%

14%

3%

4%

Less than an hour

2-‐3 hours

4-‐6 hours

6-‐9 hours

More than 9 hours

0% 25% 50%

Survey I

Survey II

Similar to last year’s results, well over half of respondents spend a minimum of 2 hours searching for documents.


(n=xxx)

(n=xxx)

ONLINE TOOLS General Analysis

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An&cipated Benefits

BENEFITS SURVEY I (n=xxx)

SURVEY II (n=xxx)

It will reduce the amount of paper I use 68% 71%

I can get up to date informa7on right away 68% 66%

Easier to keep track of informa7on 62% 60%

Not spend so much 7me searching for informa7on 47% 49%

Reduce 7me spent on study management 39% 41%

Reduce # of systems used when communica7ng with sponsors 37% 39%

Reduce possibility of human error 37% 39%

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Similar to last year, most respondents cited the reduc/on in the amount of paper used, being able to access updated informa/on right away and being able to keep track of informa/on easily as benefits of an online tool.


Interest in Online Tool to Complete Site Feasibility Surveys Across Sponsors Using One Login/Password

76% 74%

5% 5%

19% 21%

0%

20%

40%

60%

80%

100%

SURVEY 1 SURVEY II

Maybe No Yes

17

Similar to last year, the majority of respondents expressed a willingness to try an online tool with one login and password to complete site feasibility/site recruitment surveys across mul/ple sponsors. Those that hesitated expressed concern about the poten/al complexity/user-‐friendliness of the tool.

Sta7s7cally significant at 95%: None (n=XXX) (n=XXX)

RESPONDENT PROFILE Background

18

Type of Organiza&on

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Over half of respondents work at a public/private hospital or at a university hospital/academic medical center.

11% 12% 1% 3%

18% 16%

9% 11% 1% 2% 2%

1%

35% 31%

22% 23%

0%

20%

40%

60%

80%

100%

SURVEY I SURVEY II

Public/Private Hospital

Univ. Hospital/AMC

VA/Military Hospital

SMO

Ind. Prac7ce

Group Prac7ce

Primary Outpa7ent Care

Research Center

Other

2% 1%


(n=598) (n=600)

Therapeu&c Areas

20

Therapeu&c Area SURVEY I (n=XXX)

SURVEY II (n=XXX)

Oncology 33% 25%

Cardiology 15% 17%

Hematology 13% 11%

Diabetes 12% 12%

Pulmonary/Respiratory 11% 11%

Gastroenterology 11% 13%

Neurology 10% 9%

Pediatrics 8% 5%

Rheumatology 8% 8%

Internal Medicine 8% 7%

Medical Devices 8% 7%