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.