Jeffry Florian, PhD
Clinical Analyst, Office of New Drugs
FDA Center for Drug Evaluation and Research (CDER)
Clinical Trials Transformation Initiative (CTTI)
Penny Randall, MD, MBA
VP and Global Therapeutic Head, CNS
A New Path Forward for Using Decentralized Clinical Trials
Decentralized clinical trials; Telemedicine; Mobile health; Clinical Trials Transformation Initiative; FDA
- Decentralized clinical trials (DCTs) are defined as those executed through telemedicine, mobile, or local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model; for example, shipping investigational medical product directly to the trial participant.
- DCTs are not “all or nothing.” They exist in a broad continuum and can expand the reach of traditional clinical trial sites.
- Potential benefits of DCTs 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.
- Mobile HCP training is similar to that required for standard investigative sites: Good clinical practice, protocol-specific training, human subject protections, data protection, and clinical trial billing.
Will a decentralized trial lead to less diverse patient populations as participants will need to be technology literate and have access to technology?
Decentralized clinical trial safety monitoring plans should not be held to a higher standard than with traditional trials unless merited by a particular circumstance. It is important to develop protocol-specific safety monitoring and communication escalation plans.
Download CTTI’s recommendations for decentralized clinical trials.
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