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Chapter 1: How to Use EHR to the Fullest in Your Clinical Trial?

EHR for Clinical Trials

Why do EHR data still need to be better for clinical research?

Traditional clinical trials are becoming more expensive and complicated, which could prevent new drugs and medical devices from being developed. However, with technology, patients get more involved in research. 

This new model means that participants have much more power and authority in the clinical trial process. Researchers can use technology (EHR, mobile apps, wearables, sensors, etc.) to make clinical trials more efficient and practical. 

How?

  1. First, the United States Food and Drug Administration (FDA) recently announced the creation of the Center of Excellence for Digital Health. The center aims to help the digital health industry grow while protecting patients. 
  2. Second, large technology companies such as Microsoft, Google, and Amazon announced their intentions to move into health and healthcare research. 
  3. Finally, venture capital funding for digital health technologies surpassed $8 billion in 2018. This is more than was invested in all medical devices combined.

Why Is It Only The Beginning of EHR transformation?

Almost all hospitals have changed from paper to electronic health records (EHRs) in the last ten years. EHRs are digital records that are updated in real-time and contain information about patients’ diagnoses, treatments, laboratory tests, administered drugs, and clinical encounters. Clinical data from EHRs can help with different trial parts, including planning and design, ensuring the trial site is ready, conducting the trial, collecting data, ensuring the trial is representative, and following up on clinical events.

The FDA recently released a document that said they want to work with others to study how you can use electronic health records (EHRs) to make clinical trials more efficient. EHRs have the potential to revolutionize how clinical trials are done. Still, some barriers must be overcome first, including data that needs to be more accurate and complete and privacy and interoperability issues.

Questions for better use of EHR in preparing for an RCT (random controlled trial) study:

  1. Where can I find multiple sources of EHR data relevant to the study?
  2. How usable is inclusion and exclusion criteria? 
  3. How can I define and narrow down my desired cohort? 
  4. How feasible is this study? 
  5. How accurate is this data?

Common problems and Solutions of EHR:

PROBLEMSSOLUTIONS
IT’S A HOT MESS: Lack of accuracy, completeness, interoperability, and slow updates of EHR dataCreation of continuously updated and curated data at individual sites that are linkable across a research network
TOWER OF BABEL: Heterogeneity of data element definitionsAdoption of standardized medical vocabulary
HE SAID, SHE SAID: Variable accuracy of EHR-derived endpointsA subset of specific measurements is being used to compare to a standard to see if the treatment worked.
HOW WILL YOU USE MY DATA? Privacy concerns of participantsPatient engagement in the design of the protocol
ANOTHER APP? Low clinician engagement to use EHR-enabled tools to recruit patients into pragmatic trialsIntegrates point-of-care trials seamlessly in the clinical workflow, and prevents alert fatigue via accurate UX/UI design.

Stay tuned for the next article, where we explore clinical informatics in trial planning and screening!

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