04/11/2023
Decentralized clinical trials (DCTs) have increased in popularity during the pandemic. The US Food and Drug Administration (FDA) released guidance on Conduct of Clinical Trails of Medical Products During the COVID-19 Public Health Emergency that clarified that decentralization of clinical trials through remote collection of data outside of a physical location is permissible as long as methods follow regulatory requirements. Examples of remote methods include electronic consent, virtual visits, home health visits, local imaging or laboratory assessments, and delivery of investigational product to home. Sponsor oversight of the DCT vendors is just as important as for traditional model clinical trials. DCTs 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 can also pose additional challenges, mainly due to the nature of remote trial conduct and the increased reliance on vendors. A recent example where DCT vendor oversight was lacking is a Lyme disease clinical trial. The Press Release explains that the sponsor discontinued about 3500 enrolled participants due to Good Clinical Practice violations at certain clinical trials sites managed by a Decentralized Research Organization (DRO) The DRO offers services such as mobile research teams, remote principal investigator oversight, remote study managers, and set up of remote support like laboratory processing.
Although the press release does not go into details about the specific GCP violations, they were widespread and concerning enough to discontinue half the enrolled participants. These GCP issues would have taken some time to accumulate, and it is surprising that it was not discovered earlier. Appropriate vendor oversight includes not just selection of the vendor, but effective oversight of the delegated responsibilities through regular meetings, data review, and other sponsor oversight activities. The lack of oversight was costly to the sponsor in loss of time, finances, and reputation.
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- The Clinical Pathways Team
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