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EMRs and Clinical Research: Current and Potential Impact

  • October 2013
  • -
  • Industry Standard Research
  • -
  • 58 pages

In this report, ISR leverages the insights and real-world experiences investigative sites have with electronic medical records (EMRs) and clinical trials.

The report examines how sites currently use EMRs for various clinical trial activities and provides recommendations to improve trial efficiency.

Valuable for:

• Clinical Operations
• Project Managers
• Data Management
• Patient Recruitment
• Site Selection
• Technology Providers

Areas of responsibility:

All respondents have direct responsibility for coordinating clinical research at an active investigative site.

Regions Analyzed:

USA

What you will learn in this report:

• How EMRs are being used in clinical trials – benefits, drawbacks, and suggestions for EMR integration and adapting to workflow
• The process for utilizing EMRs at investigative sites for clinical research is far from standardized – identify the impact this underperformance is having on feasibility, recruitment, timelines, CRF data entry, and patient care
• Which EMR vendors are currently being used and how satisfied sites are with these systems with respect to the clinical trial process
• Next steps for EMR adoption. Increasing the use of EMR in clinical studies.

How you can use this report:

For Sponsors and CROs:
• Benchmark the industry’s use of EMR and understand the advantages and limitations from a site perspective
• Leverage sites that use EMR vendors with the highest site satisfaction
• Strengthen relationships with sites by understanding their expectations for use, integration, and their need for assistance
• Understand the impact EMRs are having on sites’ ability to develop trial efficiencies

For Technology Providers:
• Benchmark your performance against your competition
• Anticipate how changes in trial volume and adoption/penetration will affect your future business opportunities
• Identify operational improvements and product characteristics that impact trial success and optimize user experience

Table Of Contents

EMRs and Clinical Research: Current and Potential Impact
Table of Contents

Copyright and Usage Guidelines 4
Introduction 5
Methodology 6
Major sections 7
EMR adoption and impact 7
Process development 7
Vendor use and sponsor/CRO involvement 7
Future of EMR 7
Complete study data 7
Executive summary 8
EMR adoption and impact 9
Processes development 12
Vendor use and sponsors/CRO involvement 17
Future of EMR 22
Length of EMR use 26
Benefits of EMR 27
Drawbacks of EMR 28
Improvements to EMR functionality for clinical trials 29
Improvement from a sponsor/CRO for EMR use in clinical trials 30
Use of EMR data for feasibility response questionnaires 31
Barriers to using EMR for feasibility response 31
Impact of EMR on feasibility rates 32
Percent of sites that use EMR to proactively recruit patients 33
Why not proactively recruit? 34
Percent of sites that spontaneously recruit patients using EMR 35
Why not spontaneously recruit? 35
Impact of EMR on the number of patients enrolled 36
Meeting recruitment goals prior/ after EMR implementation 37
Use of a proactive alert for patient recruitment 38
EMR helpfulness in identifying patients otherwise not identified 38
Change in number of patients recruited post-EMR adoption 39
Change in number of studies conducted post-EMR adoption 39
Reasons for increase EMR use in clinical studies 40
Percent of sites with EMR and EDC integration 41
Familiarity with FDA “EDC as source data” Guidance (November, 2012) 41
Site interest in using CRO/Sponsor-provided data capture devices 42
Impact of EMR use on speed of CRF data entry process 43
Impact of EMR use on accuracy of CRF data entry process 43
Impact of EMR on number queries received 44
Average percent increase in queries response 45
Average percent decrease queries response 45
EMR areas needing improvement for clinical trial operations 46
Areas outside parties could assist EMR use in clinical trials 47
Percent of trials that a sponsor helps a site find patients with EMR 48
Percent of trials that a CRO helps a site find patients with EMR 49
EMR vendor use 50
Satisfaction with current EMR vendor 51
Respondent demographics and qualifications 52
Clinical site staff 52
Office type 52
EMR use and familiarity 53
Primary role 53
Clinical research responsibility 54
Number of trials respondent involved in over past 12 months 55
Number of trials office conducted in past 12 months 55
Therapeutic areas 56
Office location 57
Site revenue from clinical trials 57
About Industry Standard Research 58

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