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EMRs and Clinical Research: Current and Potential Impact

  • ID: 2739739
  • Report
  • April 2013
  • 58 Pages
  • Industry Standard Research (ISR)
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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.
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Copyright and Usage Guidelines
Major sections
EMR adoption and impact
Process development
Vendor use and sponsor/CRO involvement
Future of EMR
Complete study data
Executive summary
EMR adoption and impact
Processes development
Vendor use and sponsors/CRO involvement
Future of EMR
Length of EMR use
Benefits of EMR
Drawbacks of EMR
Improvements to EMR functionality for clinical trials
Improvement from a sponsor/CRO for EMR use in clinical trials
Use of EMR data for feasibility response questionnaires
Barriers to using EMR for feasibility response
Impact of EMR on feasibility rates
Percent of sites that use EMR to proactively recruit patients
Why not proactively recruit?
Percent of sites that spontaneously recruit patients using EMR
Why not spontaneously recruit?
Impact of EMR on the number of patients enrolled
Meeting recruitment goals prior/ after EMR implementation
Use of a proactive alert for patient recruitment
EMR helpfulness in identifying patients otherwise not identified
Change in number of patients recruited post-EMR adoption
Change in number of studies conducted post-EMR adoption
Reasons for increase EMR use in clinical studies
Percent of sites with EMR and EDC integration
Familiarity with FDA - EDC as source data - Guidance (November, 2012)
Site interest in using CRO/Sponsor-provided data capture devices
Impact of EMR use on speed of CRF data entry process
Impact of EMR use on accuracy of CRF data entry process
Impact of EMR on number queries received
Average percent increase in queries response
Average percent decrease queries response
EMR areas needing improvement for clinical trial operations
Areas outside parties could assist EMR use in clinical trials
Percent of trials that a sponsor helps a site find patients with EMR
Percent of trials that a CRO helps a site find patients with EMR
EMR vendor use
Satisfaction with current EMR vendor
Respondent demographics and qualifications
Clinical site staff
Office type
EMR use and familiarity
Primary role
Clinical research responsibility
Number of trials respondent involved in over past 12 months
Number of trials office conducted in past 12 months
Therapeutic areas
Office location
Site revenue from clinical trials
About Industry Standard Research
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This report provides the pharmaceutical industry and its service providers with novel insights into the current and future use of electronic medical records (EMRs) by clinical sites for clinical development.

“While government incentive programs have driven the adoption of EMRs, ISR has found that investigative sites are still in the early stages of optimizing these technologies to positively impact clinical research,” Andrew Schafer, President of ISR explained. “ISR’s newest report found that just because a medical practice has an EMR system installed, does not mean that they have integrated the system into the clinical research workflow.”

The study study highlights significant opportunity for EMR vendors and trial sponsors. ISR surveyed 102 site coordinators and principal investigators with responsibility for clinical research and the analysis allows readers to:

- Learn how sites currently use EMRs for various clinical trial activities
- Understand the impact EMRs are having on patient recruitment and feasibility assessments
- Identify which EMR vendors are being used and which have the highest satisfaction ratings
- Uncover methods to better manage relationships with investigative sites
- Receive recommendations to improve trial efficiency
- Compare end-user satisfaction ratings across several major EMR platforms
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