Currently, clinical trials are conducted at a center where the subjects have to return for study visits. This can be burdensome and may slow down enrollment or lead to reduced compliance or retention. In decentralized trials (DCT), subjects may meet study requirements without the need to return to the study site. CTTI has released its recommendations for DCT.
How do DCTs Work?
DCTs do not need to be completely decentralized but should use a fit for purpose approach.
Subjects can be screened for eligibility through a teleconference.
Visits can be utilized for major medical tests such as MRIs.
Minor tests such as blood draws can be completed remotely.
The decision on how much can be decentralized is a balance between the need for high quality data and reduced burden, which depends on the specifics for the trial.
What Should be Done Before Starting a DCT?
Reach out to IRBs about their perspective on the study design.
Have early, clear, and frequent conversations with regulatory agencies about plans for using DCT.
Create Standard Operating Procedures (SOPs) for DCT.
What are Some Concerns Specific to DCT?
In the US, the practice of medicine is state-regulated.
Mobile healthcare providers should be licensed to practice in any state where the study may be conducted.
An investigator licensed in each state used is needed for oversight.
State laws may differ for direct to patient shipment of study drugs.
The sponsor or CRO should create a process to ensure compliance with any applicable state laws.
The process should be described in the protocol.
An SOP for accountability should be written.
How Does Investigator Oversight Change with DCT?
Delegation should work the same for DCT as in traditional studies.
There could be additional concerns over where routine care ends and clinical trial care starts if primary care providers are utilized.
Clearly defined roles and procedures written in the protocol are recommended.
Recommendations for who should be listed on Form FDA 1572 are to consider:
what individuals are doing for the study,
the stated responsibilities in the protocol, and
if they have a supervisory role.
How Does Safety Monitoring Differ?
Safety monitoring should be held to the same standard as with traditional studies.
The safety monitoring plan should be customized for the investigational product and the protocol and it should:
clearly explain the safety procedures, and
ensure adequate training of DCT-specific processes.
Subjects should understand what to do if they have an adverse event.
Create a list of approved remote healthcare providers and facilities.
Plan for good communication between the investigator and the facilities to ensure appropriate reporting.
Decentralized trials may reduce burdens on subjects and have greater reach into populations, thus increasing enrollment and retention and reducing the time it takes to get an investigational product to market. DCTs pose different challenges and are under increased scrutiny from regulatory authorities. The CTTI recommendations intend to provide enough information for sponsors to confidently use DCTs when it is appropriate for the investigational product and the protocol.
- The Clinical Pathways Team
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