Decentralized clinical trials (DCTs) present an opportunity for the clinical research and healthcare industries to approach research in forward-thinking ways, allowing patients to see clinical trials as a healthcare option.

Key Benefits of DCTs

DCTs rethink and refresh clinical care while keeping focus on the patient. DCTs are executed using all or some of the following elements of decentralization:

  • Telehealth visits
  • Communication technologies (e.g., smartphone and table computers)
  • Digital health technologies (e.g., wearables and sensors)
  • E-consent/assent
  • E-signatures
  • E-source data
  • E-COAs (e.g., ePROs and eObsROs)
  • Direct to patient (DTP) shipment of investigational medical products (IMPs)
  • Mobile and/or local healthcare providers to leverage standard healthcare systems
    • Local clinical laboratories
    • Local clinical imaging services
    • Local clinics and/or centers
    • Local pharmacies

In DCTs, safety and efficacy data of IMPs may be collected remotely from patients who remain at their homes or ecosystems where they live (e.g., their own towns or cities). The clinical data may also be collected from participating local healthcare-related services such as local healthcare providers, clinical laboratories, clinical imaging facilities, or pharmacies. DCTs may involve fewer clinic visits, therefore reducing patient, clinical research site, and caregiver burdens.

The patient-centric approach of DCTs breaks traditional paradigms by reflecting a transformational philosophy for clinical trial conduct.

Decentralized Clinical Trials (DCT) Fact Sheet

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