Electronic Data Capture The Importance of Technology in research

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Electronic Data CaptureThe Importance of
Technology in research

• Shari Edevane

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During this presentation we will

• Discuss the benefits of EDC
• Examine barriers to the use of EDC in clinical
  research
• Discuss ethical and legal issues related to the
  use of EDC in research
• Describe the competencies of the professional
  nurse when using EDC
• Discuss the functions of the nurse informatics
  specialist when working with EDC

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Who benefits from the use of EDC?

• Benefits of EDC to research participants?
• Benefits of EDC to the clinical research
  organizations and the pharmaceutical sponsors?
• Benefits of EDC to the Investigator?

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Clinical research is a complex, lengthy and
expensive process.
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Pharmaceutical companiesrely on quality data
being collected and recorded across the globe,
and collated at central databases to give a
detailed picture of the risk vs. benefit of their
drug.
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In 1998, at an Association of Clinical Research
Professionals conference, research professionals
only pondered the use of technology in capturing
data for clinical trials.
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By 2005, 40 of all clinical trials in the USA
were using electronic data capture.


(BIO-IT WORLD,2005)
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By October 2009, 58 of clinical trials were
registered using electronic data capture.


(Sheilds, 2009)
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What is EDC?

• Electronic Data Capture , or EDC, is an
  computerized system designed for the collection
  of clinical trial information in electronic format

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Where does data entered into EDC go?
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EDC systems typically provide

• A graphical user interface component
• A validation component to verify user data
• A reporting tool for analysis of the data
  collected

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To enter EDC for a trial you will need

• A computer
• Internet access
• EDC software
• Such as PhaseForwards Inform System,
  Medidata, Datatrak, Oracle Clinical EDC
• User id and password provided by the sponsor

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Phase Forward Inform System
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Medidatas Rave EDC System
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How does EDC benefit the patient?

• Efficient electronic SAE (serious adverse
  event)process
• Faster access to critical patient data,
  identifying trends in adverse events that may not
  been detected in smaller phase I and phase II
  clinical trials
• (Meyer, Knoesel, LUX, 2008)

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How does EDC benefit CROs and the Sponsors

• Reliable real-time data is immediately available
  for review by biostatistical experts
• EDC provides the fastest way to obtain accurate
  information about clinical trial performance
• The great volume of information is organized for
  more timely review of safety and efficacy issues

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How does EDC benefit the Investigator?

• GCP compliance is ensured at the site level by
  timely data submission to the pharmaceutical
  sponsor
• Legible information
• Improved data quality
• (Brooks, Kristin 2007)

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Barriers to EDC

• Concerns of data security
• Technical glitches
• (Williams, Jeff, 2009)

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Ethical and legal debates

• Pros

• Cons

• Improved access to legible patient records may
  reduce vulnerability to malpractice claims
• Patients are informed earlier of safety issues
  with the drug when using EDC vs paper case
  report forms.

• The electronic transmission and storage of
  patient data
• Computers used in EDC are no longer mantained by
  the pharmaceutical company.