Essential contents of the FDA guidance for DCT:

The US Food and Drug Administration (FDA) has published a draft guidance on decentralised clinical trials (DCT) for drugs, biologics, and medical devices "Decentralized Clinical Trials for Drugs, Biological Products, and Devices" in May 2023.

DCTs are clinical studies in which some or all study-related activities take place outside of traditional study centres, for example in participants' homes or local health institutions.

Introduction and background

The guidance is aimed at sponsors, investigators and other stakeholders and is intended to facilitate the implementation of DCTs. The document provides guidelines for the planning and conduct of decentralised clinical studies that are conducted partially or completely outside of traditional clinical trial centres. The objective is to facilitate participation in clinical studies and expand the geographical reach.

Definition and scope

Decentralised clinical studies (DCTs) use digital technologies and telemedicine to collect data and monitor participants. These trials can be fully decentralised or take a hybrid form, with some activities conducted on-site and others remotely.

Advantages and challenges of DCTs

DCTs offer several potential benefits: they can increase access to a more diverse patient population, improve study efficiency and reduce the burden on participants and carers. Through the use of telemedicine and digital health technologies, fewer in-person visits to study centres may be required. However, DCTs also pose challenges, especially when it comes to coordinating study activities at different sites.

FDA recommendations for the implementation of DCTs

Study design

When planning a DCT, sponsors should carefully consider which study activities can be decentralised. Fully decentralised studies are more suitable for investigational medicinal products with simple administration and a well-characterised safety profile. Hybrid designs with a combination of centralised and decentralised elements may be appropriate in many cases.

Remote visits and study-related activities

The guideline recommends the use of telemedicine for study visits when no face-to-face interaction is required. Study staff can also be sent to participants' homes. Local healthcare providers can be used for certain study-related activities, provided these are part of their usual clinical practice.

Digital health technologies

The use of digital health technologies (DHTs) for remote data collection is discussed. Sponsors should ensure that DHTs are available and appropriate for all participants.

Roles and responsibilities

The responsibilities of sponsors and investigators are described in detail. Investigators remain responsible for the conduct of the study and the monitoring of delegated activities. The guideline provides recommendations on the delegation of tasks to local healthcare providers and the documentation of these delegations.

Consent and ethics committee

Obtaining electronic consent from participants in remote locations is possible, provided that all regulatory requirements are met. The use of a central ethics committee is recommended for DCTs.

Investigational medicinal products in DCTs

The guideline discusses considerations for the administration of investigational medicinal products outside of traditional study centres. The type of investigational product and its safety profile are critical to its suitability for decentralised administration.

Safety monitoring

Sponsors must implement a safety monitoring plan that takes into account the decentralised nature of the study. The plan should describe how adverse events will be recorded and addressed.

Conclusion of the FDA document

The FDA guidance on decentralised clinical studies provides comprehensive recommendations for planning and conducting DCTs. In it, the FDA encourages sponsors and researchers to use these approaches to facilitate participation and expand geographic reach while ensuring the safety and integrity of the trials.

This summary provides an overview of the key points of the document. For detailed information and specific instructions, it is recommended to consult the full document.

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