eSource – A Research Site Perspective

eSource Data in Clinical Investigations

May 2-3, 2017

Dan Milam
VP, Global Engagement
SCRS
Dan.Milam@mySCRS.org
SCRS Membership
4,400+ Sites Strong & Growing

14%
8% Practice 47 Countries

Freestanding
50%
Hospital
28%
Academic

Conduct 10+ Studies Annually (avg)

82% - 10+ yrs experience
Glimpse Into the World of a Site
What Impacts Site Sustainability
1. Lack of study opportunities
2. Uncompensated activity
3. Staffing
4. Cash flow
4. Recruitment
5. Prices paid for services

Source: SCRS Summit Survey 2016

Protocol Complexity
50
45
Protocol Complexity (Media)

40
35
30
25
20
15
10
5
0
2000-2002 2003-2005 2006-2008 2009-2011 2012-2015

Source: Medidata - N = 8275 studies, phase II & III, all TAs

Average Payment Per Visit
w/vaccines w/out vaccines
$1,000 $809 $847
$800
$800 $721
$880 $890
$600 $772 11% Decrease

$400 $511
$200
$0
2013 2014 2015 2016
Both exclude screen failures and discontinued patients

Source: CFS Clinical 2013, 2104, DrugDev 2015, 2016

Less Than 3 Mos. Operating Cash

Operating Cash

67
66 66%
65 65%
64
63
62
61
60
2014 2016

Source: SCRS Summit Survey 2104, 2016

eSource – Survey of the Site
With advancements in technology –
 Why are we collecting data the “old way”?
 Are sites ready to make the change?
 Technology’s Impact on
Site Efficiency

18%

44%
38%

Increased Decreased No Change

Source: SCRS Summit Survey 2016

 Technology Realities
Other

Insufficent tech support

Systems not aligned w/site workflow

Too many usernames/passwords

Incompatiable w/each system

Reptitive training

Too many systems

0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20%

Source: SCRS Summit Survey 2016

Solution to Data Entry
FDA Guidance Document
Source Data Capture

• Data can be entered into the eCRF either manually or

electronically as described below.

a. Direct Entry of Data Into the eCRF

• Many data elements (e.g., blood pressure, weight, temperature,

pill count, resolution of a symptom or sign) in a clinical
investigation can be obtained at a study visit and can be entered
directly into the eCRF by an authorized data originator. This
direct entry of data can eliminate errors by not using a paper
transcription step before entry into the eCRF. For these data
elements, the eCRF is the source. If a paper transcription step
is used, then the paper documentation should be retained and
made available for FDA inspection (see section III.A.2.c).
The Research Site Source Survey

• SCRS collaborated with

CenterWatch and Clinical Ink
• October 2016 - December 2016
• 656 respondents were obtained
• 87% U.S.-based sites
• 13% International sites
Sites Surveyed
(N = 656)

39%

33%

17%

8%
4%

Practice-based Independent Hospital-based Academic Other

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May 2017.
Survey Objective
To investigate clinical trial site source
data collection behaviors
and methods, and
uncover inefficiencies
in site activities
What Did the Sites Say?
 Adoption of EMR
 Clinical Trial Data Collection
 Study Source Document Creation
 Study Data Transcription

Is eSource the solution?

EMR Adoption Rates

Source[3]: 111th Congress (2001-2010). H.R.1 - American Recovery and Reinvestment Act of 2009. Available at https://www.
congress.gov/bill/111th-congress/house-bill/1ailab Accessed: April 2017
EMR = Solution?

Does EMR reduce study the site

burden in clinical research?
EMR for Research Studies
64% overall
adoption of EMR

(N = 656)

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May 2017
EMR Impact on Source Creation
Do you create study- 97%

specific source 86%

documents for each

study? (N = 656, P<0.01)

14%

3%

No Yes
Does not use EMR to record non-study related patient medical information Use EMR to record non-study related patient medical information

Why are sites with EMR only 11% less likely to create study-specific source documents?
EMR Summary
 EMR technology has added efficiencies to
healthcare information management

 Those efficiencies have not translated to data

collection for research trials.
Burdens on the Site
 Creating Source Form Worksheets

 Transcription to EDC
Status Quo – Paper Source

N=590

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May 2017
Source Form Creation

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May 2017
Why Create Source?

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May 2017
Time to Create Source Docs?
54% spend more than one working day
34% greater than 4 working days

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May 2017 (N=590)
Time to Create Source Docs?

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May2017. (N=590, P<0.05)
Elimination of Data Transcription?
79% of sites found it helpful / extremely
helpful to record study data directly in eSource

More than Adequate/Adequate for study data

collection

N=656; P<0.01

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May2017.
Time to Enter Data for ONE Visit
Minutes

91+

60-90

31-59

< 30

0 10 20 30 40 50 60

SCRS Summit Survey 2016

Site’s Resource Needs
An Example…

 58 mins per patient visit for data entry

 Average 10 visits per study patient
 Average 8 patients per study

Total data entry time = 77 hours for 1 study

Transcription Costs
Hourly Coordinators’ Resource
$28.75 / hour*
Spend
Percentage of Surveyed
Time Spent Entering EDC Per Visit Sites Fitting in Each Estimated Cost / Site / Visit
Category
< ½ hour (Median = 15 minutes) 18% $1.26
½ - 1 hour (Median = 45 Minutes) 45% $9.66
1 – 1 ½ Hours (Median = 75 Minutes) 19% $6.90
1 ½ - 2 Hours (Median = 105 Minutes) 8% $4.22
> 2 hours (120 minutes) 10% $5.78
Average Median Time Spent on Data Transcription per Study
58 Minutes
Visit
$27.83/
Est. Total Resource Spend Per Site Per Study Visit $278 (10 Visits)
Visit
Est. Total Spend 8 Patients / Study $2,224
Est. Total for Industry in 2015 [6]
(22,568 Studies) $50.2 Mil

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May2017. (N=590, P<0.05)
Best of Both Worlds
Will leveraging eSource
technology reduce the burden
on sites and create efficiencies?
 eSource –
A Solution to the Site Burden?
Average Time (Hours) Spent Creating Source Forms (Per Study)* 15.98
Average Time (Hours) Spent Transcribing Data into EDC (Per Patient Per Study)* 7.73
Average Time (Hours) Spent Conducting Study Visit (Per Patient Per Study)** 8.00
Study Site Scenario: 10 Patients Enrolled and Data Entered
Hours Months
Current Source Method 173 1.00
eSource Technology Method*** 100 0.58
% site capacity that can be used for critical study activities with eSource
42%
technology
Estimated reduction in workload with eSource technology 0.42 Months
* Data obtained from Research Site Source Survey, assumes 8 visits per study
** Source: SCRS
*** Includes a 25% increase in study visit time with using eSource technology

Source: SCRS. Why Is Clinical Source Data Still Collected on Paper? May2017. (N=590, P<0.05)
eSource: Data Quality Solutions
 Eliminate EDC transcription errors
 eSource updated with protocol and CRF amendments
 Study procedures compliant with protocol data
collection requirements
 Guidance and data collection instructions for study
visit procedures
 Real-time queries to ensure data is captured correctly
at the time of the visit
Survey Summary…
 EMR
 Introduces efficiencies to the healthcare industry
 Benefits not yet seen in clinical trials
 Source Document Creation
 90% of sites still create study-specific source documents
 54% of site spend >1 working day to create study sites are still creating study source documents
 Data Transcription
 58 minutes per study visit to enter data into EDC
 Sites spend thousands per year
 Data entry errors and quality risks
 eSource – Potential Benefits
 79% of sites found it helpful / extremely helpful to record study data directly in eSource
 Increased efficiencies for study workload
 Visit procedure instructions and guidance
 Real-time queries
 Immediate data access to sponsors for risk assessments
 More time to spend with Patients
 More time recruiting for studies
It’s All About The Patient
eSource technology will enable
sites to more time and resources
to focus on their patients and
critical study tasks?
myscrs.org