Uses of Electronic Data

>> Project Summary


Clinical Trial Program DesignUses of Electronic Data to Support Clinical Trials
(with Mini-Sentinel)

Project Status: Closed


What is the issue?

More and more health records are being created and stored digitally in electronic medical records, or EMRs. This wealth of data represents an opportunity to answer questions of clinical importance using pre-existing and searchable data, which would present an enormous cost and time savings over going out and redundantly collecting similar data in a clinical setting. EMRs have already been used for some types of observational studies, where researchers look at the medical history of patients to try to find patterns of association between behavior or treatment and medical outcomes. However, many questions remain about the practical considerations of using EMRs for other types of studies. For example, could EMRs be used to recruit and follow-up with participants for clinical trials where an intervention might be randomly assigned to one group of patients?

An enormous database of EMRs has been created by the FDA and approximately 20 data partners, which include health insurance companies and medical centers. The purpose of this database, called the Mini-Sentinel Distributed Database, is to quickly identify and assess health and safety problems related to FDA-regulated medical products. If it were feasible, using this existing database to conduct research in addition to its intended use of public health surveillance would be an effective and efficient use of resources.


What is the goal of this project?

This project aims to determine the feasibility of using the Mini-Sentinel Distributed Database to facilitate recruitment and follow-up of participants in randomized trials.


What is the objective of this project?

Produce a report with recommendations for expanding the use of the Mini-Sentinel Distributed Database for clinical trials


What will we do?

A collaborative workgroup from Mini-Sentinel and CTTI will examine the following issues:

  • Feasibility of using the Mini-Sentinel Distributed Database to facilitate recruitment and follow-up of participants in randomized trials.
  • Approaches to identifying potential participants, enrolling participants, obtaining informed consent, ensuring patient privacy, randomizing participants into different treatment groups, and ascertaining different outcomes using EMRs.
  • Appropriate oversight of such research.
  • Willingness of the Mini-Sentinel data partners to participate in research projects.
  • Estimates of the cost of recruiting study participants through the Mini-Sentinel database.


What will we produce?

A report describing the results of our analysis.



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