To facilitate the adoption and appropriate use of mobile technology in clinical trials, the Clinical Trials Transformation Initiative (CTTI) initiated the Mobile Clinical Trials (MCT) Program, which includes four projects focused on the following topics: Decentralized Clinical Trials (DCTs), Novel Endpoints, Stakeholder Perceptions, and Mobile Technologies. The MCT DCT Project concentrates on the actual and perceived legal, regulatory, and practical challenges with DCT design and conduct in the United States.

For the purposes of these recommendations, DCTs are defined as those executed through telemedicine and mobile/local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model (e.g., the investigational medical product [IMP] is shipped directly to the trial participant).

OVERVIEW: Expanding the Reach of “Traditional” Clinical Trial Sites

Telemedicine, mobile, and local HCPs (e.g., family physicians, general practitioners) have been involved extensively in healthcare delivery but have yet to be widely incorporated into the design and conduct of clinical trials. This is due in part to legal, regulatory, and practical considerations, which are viewed as potential barriers.

DCTs using telemedicine and other emerging and novel information technology (IT) services offer the potential for local HCPs to participate in clinical trials. This may provide several advantages compared to traditional clinical trials conducted at more centralized clinical trial sites, including the following:

  •   Faster trial participant recruitment, which can accelerate trial participant access to important medical interventions and reduce costs for sponsors.
  •   Improved trial participant retention, which may reduce missing data, shorten clinical trial timelines, and improve data interpretability.
  •   Greater control, convenience, and comfort for trial participants by offering at- home or local patient care.
  •   Increased diversity of the population enrolled in clinical trials.
  •   An opportunity for home administration or home use of the IMP, which may bemore representative of real-world administration/use post-approval.

    These potential advantages and benefits apply to all trials in all disease areas but may offer particular advantages in rare diseases, where patients are generally limited in number or are highly geographically dispersed.

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