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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 ...

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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EMRs and Clinical Research: Current and Potential Impact EMRs and Clinical Research: Current and Potential Impact Document Transcript

  • EMRs and ClinicalResearch: Current andPotential ImpactInfo@ISRreports.com ©2013 Industry Standard Research www.ISRreports.comPREVIEW
  • www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 2act with confidenceReport Overview102Respondents58Pages61Charts and GraphsQ2,2013Publication DateIn this report, ISR leverages the insights and real-world experiences investigative sites have withelectronic medical records (EMRs) and clinical trials. The report examines how sites currently use EMRsfor various clinical trial activities and provides recommendations to improve trial efficiency.1. EMR adoption and impact. How EMR systems are being used in clinicaltrials. The EMR benefits found, what drawbacks are being experienced,and the top suggestions for EMR integration into clinical researchoperations.2. Process development. Sites’ current use of EMR systems for feasibility,patient recruitment, and CRF data entry. The processes sites useregarding EMR and the overall success of these processes.3. Vendor use and sponsor/CRO involvement. List of EMR vendorsthat sites are using and sites’ satisfaction with EMR vendors. The rolessponsors and CROs are playing in EMR adoption, if any. Expectationsinvestigative sites have for how sponsors and CROs can/ should assistwith EMR applications.4. Future of EMR. Next steps for EMR adoption. Increasing the use of EMRin clinical studies.5. Complete study data. In this section ISR provides all of the datacollected in the survey.• Clinical Operations• Project Managers• Data Management• Patient Recruitment• Site Selection• Technology ProvidersAll respondents have directresponsibility for coordinatingclinical research at an activeinvestigative site.USAMajor Sections:Regions Analyzed:Valuable for: Areas of responsibility:
  • www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 3act with confidenceReport OverviewWhat you will learn in this report:• How EMRs are being used in clinical trials – benefits, drawbacks, and suggestions for EMR integrationand 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 dataentry, and patient care• Which EMR vendors are currently being used and how satisfied sites are with these systems withrespect 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 siteperspective• Leverage sites that use EMR vendors with the highest site satisfaction• Strengthen relationships with sites by understanding their expectations for use, integration, and their needfor assistance• Understand the impact EMRs are having on sites’ ability to develop trial efficienciesFor Technology Providers:• Benchmark your performance against your competition• Anticipate how changes in trial volume and adoption/penetration will affect your future businessopportunities• Identify operational improvements and product characteristics that impact trial success and optimize userexperience
  • www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 4act with confidenceTable of ContentsFull table of contents and additional sample pages available in the full preview,free on our website:http://isrreports.com/industry-reports/emrs-and-clinical-research-current-and-potential-impact
  • www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 5act with confidencewww.isrreports.com  ©2013|  EDC-­‐ePRO  Market  Trends  and  Service  Provider  Performance                26  5%  5%  4%  5%  6%  20%  14%  11%  6%  11%  50%  43%  39%  40%  31%  25%  38%  46%  49%  52%  0%   20%   40%   60%   80%   100%  Integra[on  capabili[es  with  other  applica[ons  (ePRO,  IVR)  Technical  support  from  the  vendor  The  process  for  dealing  with  queries  Speed  of  the  applica[ons,  how  fast  the  pages  load  Human-­‐machine  interface  (how  intui[ve  the  soeware  is  to  operate)  No  impact   Slight  impact   Moderate  impact   High  impact  EDC Operational ImprovementsMost impactful EDC product attributes for trial success“For each of the EDC product attributes below, please indicate how much impact eachhas on your ability to successfully run a clinical trial that uses an EDC application.”(Base  =  100)  Of  the  list  of  attributes  provided,  respondents  indicate  that  “technical  support”  and  “integration  capabilities”  had  less  of  an  impact  on  running  clinical  trial  when  compared  to  the  software  performance.  © 2013 Industry Standard ResearchSample PageIntroductionBarring some unforeseen circumstances, electronic medical records(EMR), sometimes referred to as electronic health records (EHR), willbecome one of the most important tools used to support clinical trials.However, if we were to describe the current use of EMR for clinical trials interms of a budding sports star, then we would probably describe them as“having limited experience, has all of the tools necessary, and has a lot ofupside potential.” And while the industry is still in the early stages of EMRadoption and use, the interest to electronically document and share healthinformation is at the core of clinical research. It is important to note that justbecause a medical practice has an EMR system installed does not mean thatthey have integrated the system into the clinical research workflow.Patient health information stored and updated electronically has thepotential to positively impact the biggest hurdle in clinical research,patient recruitment. Clinical study enrollment is vital for trial success.Anything that could help this process, improve timelines, and/or make theclinical development process more efficient should be at the top of everybiopharmaceutical company, CRO, or site’s development list.What is true about any type of technology is that it is only as valuable as theuser, implying that the user needs the knowledge and tools to fully leveragethe technology. This axiom applies to EMR. These systems can positivelyimpact the feasibility, recruitment, timelines, CRF data entry/ cleaning, andpatient care. Are your studies using EMR to their fullest potential?In this report, ISR leverages the insights and real-world experiencesinvestigative sites have with EMR and clinical trials to uncover multipleavenues of EMR use and adoption to determine its current and futureimpact on clinical research.
  • www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 6act with confidenceSample Pagewww.isrreports.com  ©2013|  EDC-­‐ePRO  Market  Trends  and  Service  Provider  Performance                26  5%  5%  4%  5%  6%  20%  14%  11%  6%  11%  50%  43%  39%  40%  31%  25%  38%  46%  49%  52%  0%   20%   40%   60%   80%   100%  Integra[on  capabili[es  with  other  applica[ons  (ePRO,  IVR)  Technical  support  from  the  vendor  The  process  for  dealing  with  queries  Speed  of  the  applica[ons,  how  fast  the  pages  load  Human-­‐machine  interface  (how  intui[ve  the  soeware  is  to  operate)  No  impact   Slight  impact   Moderate  impact   High  impact  EDC Operational ImprovementsMost impactful EDC product attributes for trial success“For each of the EDC product attributes below, please indicate how much impact eachhas on your ability to successfully run a clinical trial that uses an EDC application.”(Base  =  100)  Of  the  list  of  attributes  provided,  respondents  indicate  that  “technical  support”  and  “integration  capabilities”  had  less  of  an  impact  on  running  clinical  trial  when  compared  to  the  software  performance.  © 2013 Industry Standard Researchact with confidencewww.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11To determine benefits and drawbacks of using EMR, ISR asked respondents aboutthe benefits and drawbacks of their experiences regarding several topics the industryhas been discussing around EMR. ‘Accessing patient chart remotely’ receives thegreatest amount of support as a benefit to EMR, with 84% of respondents selectingit as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both of these areas, especially integration. Perhaps integration as apain point is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11    44%54%55%56%84%0% 20% 40% 60% 80% 100%Alerts to critical lab valueImproves practice workflowEnhancing overall patient careImproves clinical trial workflowAccessing patient chart remotelyBenefits39%40%52%53%0% 20% 40% 60% 80% 100%Changed practice workflowAdditional time to complete e-chartsIntegration between systemsTechnology usabilityDrawbacksTo determine benefits and drawbacks of using EMR, ISR asked respondents about thebenefits and drawbacks of their experiences regarding several topics the industry hasbeen discussing around EMR. ‘Accessing patient chart remotely’ receive the greatestamount of support as a benefit to EMR, with 84% of respondents selecting it as abenefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both these areas, especially integration. Perhaps integration as a painpoint is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11    44%54%55%56%84%0% 20% 40% 60% 80% 100%Alerts to critical lab valueImproves practice workflowEnhancing overall patient careImproves clinical trial workflowAccessing patient chart remotelyBenefits39%40%52%53%0% 20% 40% 60% 80% 100%Changed practice workflowAdditional time to complete e-chartsIntegration between systemsTechnology usabilityDrawbacksTo determine benefits and drawbacks of using EMR, ISR asked respondents about thebenefits and drawbacks of their experiences regarding several topics the industry hasbeen discussing around EMR. ‘Accessing patient chart remotely’ receive the greatestamount of support as a benefit to EMR, with 84% of respondents selecting it as abenefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both these areas, especially integration. Perhaps integration as a painpoint is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)© 2013 Industry Standard Research© 2013 Industry Standard ResearchBenefits and Drawbacks to using EMRsData available in full reportData available in full reportAccessing patient chart remotelyAlerts to critical lab valueEnhancing overall patient careImproves clinical trial workflowImproves practice workflowAdditional time to complete e-chartsChanged practice workflowIntegration between systemsTechnology usabilityact with confidencewww.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11To determine benefits and drawbacks of using EMR, ISR asked respondents aboutthe benefits and drawbacks of their experiences regarding several topics the industryhas been discussing around EMR. ‘Accessing patient chart remotely’ receives thegreatest amount of support as a benefit to EMR, with 84% of respondents selectingit as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both of these areas, especially integration. Perhaps integration as apain point is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11    44%54%55%56%84%0% 20% 40% 60% 80% 100%Alerts to critical lab valueImproves practice workflowEnhancing overall patient careImproves clinical trial workflowAccessing patient chart remotelyBenefits39%40%52%53%0% 20% 40% 60% 80% 100%Changed practice workflowAdditional time to complete e-chartsIntegration between systemsTechnology usabilityDrawbacksTo determine benefits and drawbacks of using EMR, ISR asked respondents about thebenefits and drawbacks of their experiences regarding several topics the industry hasbeen discussing around EMR. ‘Accessing patient chart remotely’ receive the greatestamount of support as a benefit to EMR, with 84% of respondents selecting it as abenefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both these areas, especially integration. Perhaps integration as a painpoint is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11    44%54%55%56%84%0% 20% 40% 60% 80% 100%Alerts to critical lab valueImproves practice workflowEnhancing overall patient careImproves clinical trial workflowAccessing patient chart remotelyBenefits39%40%52%53%0% 20% 40% 60% 80% 100%Changed practice workflowAdditional time to complete e-chartsIntegration between systemsTechnology usabilityDrawbacksTo determine benefits and drawbacks of using EMR, ISR asked respondents about thebenefits and drawbacks of their experiences regarding several topics the industry hasbeen discussing around EMR. ‘Accessing patient chart remotely’ receive the greatestamount of support as a benefit to EMR, with 84% of respondents selecting it as abenefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both these areas, especially integration. Perhaps integration as a painpoint is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)© 2013 Industry Standard Research© 2013 Industry Standard Researchact with confidencewww.ISRreports.com ©2013 | EMRs and Clinical Research: Current and Potential Impact 11To determine benefits and drawbacks of using EMR, ISR asked respondents aboutthe benefits and drawbacks of their experiences regarding several topics the industryhas been discussing around EMR. ‘Accessing patient chart remotely’ receives thegreatest amount of support as a benefit to EMR, with 84% of respondents selectingit as a benefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both of these areas, especially integration. Perhaps integration as apain point is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11    44%54%55%56%84%0% 20% 40% 60% 80% 100%Alerts to critical lab valueImproves practice workflowEnhancing overall patient careImproves clinical trial workflowAccessing patient chart remotelyBenefits39%40%52%53%0% 20% 40% 60% 80% 100%Changed practice workflowAdditional time to complete e-chartsIntegration between systemsTechnology usabilityDrawbacksTo determine benefits and drawbacks of using EMR, ISR asked respondents about thebenefits and drawbacks of their experiences regarding several topics the industry hasbeen discussing around EMR. ‘Accessing patient chart remotely’ receive the greatestamount of support as a benefit to EMR, with 84% of respondents selecting it as abenefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both these areas, especially integration. Perhaps integration as a painpoint is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)www.isrreports.com  ©2013|  EMRs  and  Clinical  Research:  Current  and  Potential  Impact                                                                            11    44%54%55%56%84%0% 20% 40% 60% 80% 100%Alerts to critical lab valueImproves practice workflowEnhancing overall patient careImproves clinical trial workflowAccessing patient chart remotelyBenefits39%40%52%53%0% 20% 40% 60% 80% 100%Changed practice workflowAdditional time to complete e-chartsIntegration between systemsTechnology usabilityDrawbacksTo determine benefits and drawbacks of using EMR, ISR asked respondents about thebenefits and drawbacks of their experiences regarding several topics the industry hasbeen discussing around EMR. ‘Accessing patient chart remotely’ receive the greatestamount of support as a benefit to EMR, with 84% of respondents selecting it as abenefit. ‘Improves clinical trial workflow,’ ‘Enhancing overall patient care,’ and‘Improves practice workflow’ also receive support from about half of the respondents.ISR was not surprised to see ‘Technology usability’ and ‘Integration between systems’as the leading drawbacks with using EMRs. In ISR’s previous technology report, 2012The EDC and ePRO Market Overview and Outlook Report, respondents had strongopinions about both these areas, especially integration. Perhaps integration as a painpoint is a trend with technology in clinical trials or just a reflection on the state oftechnology adoption.“Which of the following benefits have you experienced using your EMR/EHR system?Select all that apply.”(Base = 102)“Which of the following drawbacks have you experienced using your EMR/EHRsystem? Select all that apply”(Base = 102)© 2013 Industry Standard Research© 2013 Industry Standard Research
  • www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 7act with confidenceSample PageFull table of contents and additional sample pages available in the full preview,free on our website:http://isrreports.com/industry-reports/emrs-and-clinical-research-current-and-potential-impact
  • www.ISRreports.com ©2013 | Preview of: EMRs and Clinical Research: Current and Potential Impact 8act with confidenceOrdering InformationIndustry Standard Research (ISR) is the premier, full service market research provider to the pharmaand pharma services industries.  With over a decade of experience in the industry, ISR delivers an un-matched level of domain expertise.  For more information about our off-the-shelf intelligence and custom research offerings, please visitour Web site at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports.About Industry Standard ResearchPricing and ordering information is available on our website:http://isrreports.com/industry-reports/emrs-and-clinical-research-current-and-potential-impact