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Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation.

Guillaume Marquis-Gravel¹, Matthew T Roe¹, Mintu P Turakhia^2,3

¹Duke Clinical Research Institute, Durham, NC (G.M.-G., M.T.R., B.P.-L., E.D.P.).

|October 22, 2019

Summary

This summary is machine-generated.

Integrating electronic health records, mobile apps, and wearable devices can make clinical trials more efficient. However, overcoming implementation challenges and establishing regulatory frameworks are crucial for adopting these innovative technologies.

Keywords:

group processes randomized controlled trials as topic technology

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Area of Science:

Clinical Trials
Health Informatics
Biotechnology

Background:

Traditional randomized controlled trials face escalating complexity and costs, hindering drug and device development.
Emerging technologies like electronic health records (EHRs), mobile applications, and wearable devices present opportunities to enhance clinical trial efficiency and pragmatism.

Purpose of the Study:

To explore the application of EHR, mobile, and wearable technologies in clinical trials.
To identify how these technologies can streamline trial execution and enable innovative designs.
To determine barriers to implementation and optimal regulatory oversight frameworks.

Main Methods:

Convened a diverse stakeholder group in October 2018.
Examined the application of novel technologies in clinical trial operations.
Assessed potential benefits, implementation barriers, and regulatory needs.

Main Results:

Novel technologies offer significant potential to transform clinical trials.
Streamlining trial components and enabling innovative designs are key benefits.
Iterative implementation, continuous learning, and pilot studies are necessary for successful adoption.

Conclusions:

The integration of EHR, mobile, and wearable technologies holds immense promise for improving clinical trials.
Addressing implementation challenges and establishing clear regulatory pathways are essential.
A phased, learning-based approach is recommended for integrating these advancements into routine clinical trial operations.