Roles and Responsibilities (Section D): Most aspects of the DCT study roles and responsibilities mirror the requirements of traditional clinical trials. However, an intriguing point arises in line 180, which outlines the inclusion of a Data Management Plan (DMP) to account for multiple sources of data collection that are typically seen in a DCT model. While a DMP is normally provided with the protocol submission, within a DCT model, this could mean that data from vendors such as couriers, DCT platforms, interactive response technology systems (IRTs), wearable devices, and other technologies collecting this data would also need to be included. Careful consideration should be made if this needs to be applied as there may be situations where immediate protocol amendment could be required or at the least, as part of the annual updates to the US FDA, depending on the change and systems affected. This has the potential to create situations that necessitate a protocol amendment and potential study delays. This is an area to seek further clarification from your regulatory teams and potentially the US FDA regarding the submission and approval process for such decentralized platforms to ensure seamless trial conduct.
The Distribution and Storage of Investigational Product (Section G): Section G Lines 441-442 of the guidelines addresses the distribution and storage of investigational product (IP) in DCTs holds many more questions than answers in the debate between does DTP fall under federal or local laws, and central pharmacy or central depot. Interestingly, the US FDA does not differentiate between the use of a central pharmacy or a central depot and refers more to a decentralized distribution service which is acceptable to utilize to ship the IP directly to trial participants, enhancing convenience and patient-centricity.
The investigator or delegated trial personnel must control the release of the IP by the distributor, closely monitor receipt and use by trial participants or their representatives, and track the return or disposal of any unused product as directed by the sponsor. The protocol should also clearly describe procedures for documenting receipt and disposal of IPs. Adhering to applicable federal, state, and international laws and regulations concerning shipping IPs is a crucial consideration to ensure legal compliance in different jurisdictions.
Another area that needs more clarity is the use of protocol in Section G in lines - 419-423. As most of the industry seems to outline DTP/DCT services within a “country specific distribution plan” rather than the “protocol” itself, clarification of this should be made to the US FDA to ensure it does not create further protocol amendments should DTP/DCT not be approved for use within one or more countries upon protocol submission.
The US FDA's draft guidelines on DCT designs represent a significant step forward in embracing the potential benefits of decentralized trials. While they provide a framework for implementation, certain areas remain open to interpretation or further gray areas, calling for further dialogue and clarification. Sponsors, researchers, and other stakeholders involved in DCTs must be proactive in seeking guidance from regulatory authorities to ensure compliance, data integrity, and patient safety. Collaborating with the US FDA to address these challenges will lead to the successful integration of decentralized platforms in clinical trials, ultimately advancing medical research and improving patient outcomes.
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iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.
