23
May
2025

GCP and the Use of Wearables and Digital Biomarkers in Clinical Trials

Introduction

The integration of wearable technologies and digital biomarkers into clinical trials is revolutionizing how we collect, monitor, and interpret health data. From smartwatches tracking heart rate variability to continuous glucose monitors and digital inhalers, these tools offer real-time, patient-centric data. But with innovation comes responsibility — particularly in adhering to Good Clinical Practice (GCP) standards.

What Are Digital Biomarkers?

Digital biomarkers are objective, quantifiable physiological and behavioral data collected and measured through digital devices. Unlike traditional biomarkers, they can be gathered continuously and remotely, offering a more holistic view of a patient’s health status.

  • Gait and mobility patterns from accelerometers.
  • Sleep quality from wearable rings.
  • Cognitive function via smartphone-based tasks.

GCP Principles in the Context of Wearables

GCP ensures that clinical trials are conducted ethically and that data are credible and accurate. When incorporating wearables, several GCP principles are particularly relevant:

1.  Informed Consent

  • Participants must understand:
    • What data are being collected.
    • How frequently and for how long.
    • Who will access the data and how it will be used.

2.  Data Integrity and Validation

  • Wearable devices must be:
    • Validated for accuracy and reliability.
    • Calibrated regularly.
    • Auditable, with traceable data logs.

3.  Participant Safety and Privacy

  • Devices must be non-invasive and safe for long-term use.
  • Data transmission must comply with GDPR, HIPAA, and other privacy regulations.

4.  Monitoring and Oversight

  • Investigators must ensure that data from wearables are monitored in real-time or near-real-time.
  • Alerts for adverse events or anomalies must be built into the system.

5.  Challenges and Considerations

  • Device Variability: Different brands/models may yield inconsistent data.
  • Data Overload: Managing and interpreting large volumes of continuous data requires robust infrastructure.
  • Regulatory Uncertainty: Guidelines for digital biomarkers are still evolving, and harmonization across regions is lacking.

The Future of GCP and Digital Health

Regulatory bodies like the FDA and EMA are increasingly supportive of digital health tools, but they emphasize the need for scientific rigor and ethical oversight. As GCP evolves, it must accommodate the dynamic nature of digital technologies while preserving its core principles.

Interested in learning more about GCP auditing? Stay ahead of regulatory expectations with expert training and audit support. Contact us today! ClinAudits, LLC- Cheri Wilczek, President-email: cheri.wilczek@clinaudits.com; phone: 973-492-8108 extension 111. Our website is: www.clinaudits.com.

WHO WE ARE:

ClinAudits is a highly specialized third-party provider of auditing and Consulting services in the areas of:

Good Clinical Practice (GCP)

Good Laboratory Practices (GLP)

Good Manufacturing Practices (GMP)

Good Pharmacovigilance/Drug Safety (GPV)

 Good Tissue Practice (GTP)

Risk Evaluation and Mitigation Strategy (REMS)

Since 1999, ClinAudits has completed over 6,000 projects, and we have Grown to over 106 active consultants worldwide!