New CTTI Publication Maps the Road Ahead for Decentralized Clinical Trials

A peer-reviewed article highlighting CTTI recommendations for Decentralized Clinical Trials (DCTs) was published this month in Therapeutic Innovation and Regulatory Science. The article describes the process of identifying and addressing the legal, regulatory, and practical hurdles for planning and conducting DCTs.

DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment, improved retention, greater control and convenience for participants, and increased participant diversity. CTTI’s evidence-based and practical recommendations address roadblocks that could be hindering the widespread use of DCTs.

The article covers recommendations about trial design and conduct, telemedicine state licensing, medical product supply chain, mobile health care providers, investigator delegation and oversight, and safety monitoring that can help the industry navigate real and perceived barriers in the road to greater adoption.

CTTI Offers Path Forward for Using Decentralized Clinical Trials

CTTI Project: Supporting Decentralized Trial Approaches

The Clinical Trials Transformation Initiative (CTTI) will unveil new recommendations to speed the use of decentralized clinical trials (DCTs)—trials run through telemedicine and mobile health care providers—today at the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass.

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Legal & Regulatory Issues Affecting the Adoption of Mobile Clinical Trials

JULY 11, 2017 TO JULY 12, 2017

CTTI Project: Supporting Decentralized Trial Approaches

Meeting Objectives

  • Present findings from evidence gathering activities
  • Discuss how this evidence may be used to provide direction for the appropriate utilization of mobile technology in clinical trials
  • Describe what products CTTI should develop to equip change agents to overcome the legal and regulatory barriers that inhibit more widespread use of mobile technology in clinical trials, including for the purposes of regulatory submission

Meeting Location:

Sheraton Silver Spring Hotel 8777 Georgia Ave, Silver Spring, MD

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Conducting Multi-Center Trials: New Recommendations and Tool for Research

CTTI Project: Supporting Decentralized Trial Approaches

A collaborative research team established by the Clinical Trials Transformation Initiative (CTTI) created a new tool and recommendations to improve the efficiency and quality of multi-center clinical trials.

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