FDA Decentralized Trials and Digital Health Technologies

The Evolving Role of Decentralized Clinical Trials and Digital Health ...

Decentralized clinical trials and digital health technologies are gaining momentum in medical research, allowing research participants to partake in trials ...

Digital Health Technologies (DHTs) for Drug Development - FDA

Advances in DHTs, including electronic sensors, computing platforms and information technology, provide new opportunities to obtain clinical trial data ...

Digital Health Technologies and Decentralized Clinical Trials - FDA

Digital Health Technologies. &. Decentralized Clinical Trials. Leonard Sacks MD. Office of Medical Policy. Center for Drug Evaluation and Research. US Food and ...

Recent FDA Guidance Signals Future Growth for Decentralized ...

... trials.” The guidance also emphasizes the importance of digital health technologies (DHTs) — systems that use computer platforms ...

Conducting Clinical Trials With Decentralized Elements - FDA

Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. Decentralized elements ...

2024 FDA Decentralized Clinical Trial (DCT) Guidance

The guidance references participants use of their own digital health technology, often referred to as 'Bring Your Own Device' (BYOD), with the ...

Decentralized Clinical Trials (DCT) Draft Guidance - 06/20/2023 | FDA

In addition, digital health technologies have expanded the types of trial-related data that can be obtained remotely from trial participants. By ...

FDA Issues Final Guidance on DCTs and Decentralized Elements

Unlike traditional clinical trials, DCTs use decentralized elements like digital health technologies (DHTs), local healthcare office visits ...

Conducting Clinical Trials With Decentralized Elements - FDA

Digital Health Technologies ... health care-providing organizations are engaged in research. The guidance is available at https://www.hhs.gov/ohrp ...

Decentralized Clinical Trials Back in the Spotlight Thanks to New ...

... electronic informed consent, and digital health technologies (i.e., wearable devices). …Now with emerging data on DCT impacts and the FDA's ...

Conducting Clinical Trials With Decentralized Elements; Guidance ...

... digital health technologies to acquire data remotely. By allowing ... The guidance represents the current thinking of FDA on “Conducting Clinical ...

Decentralized Clinical Trials: Are Remote Elements Right for Your ...

By issuing this guidance now, FDA is acknowledging the growing role the digital health technologies (DHT) play in medicine and the potential for ...

FDA Guidance on Clinical Trials with Decentralized Elements

... decentralized trial designs. The FDA's guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations ...

FDA Decentralized Trials and Digital Health Technologies

We're exploring digital health technologies, their evolution and benefits, and their critical role in facilitating decentralized clinical research.

Unpacking FDA Guidance on Digital Health Technologies in Clinical ...

... trials become more decentralized and reliant on technology. Throughout this article, we'll use Aktiia's continuous blood pressure (BP) ...

FDA Takes Additional Steps to Advance Decentralized Clinical Trials

conduct of remote clinical trial visits and clinical trial-related activities in a DCT;; use of digital health technologies to remotely acquire ...

SACHRP Recommendations on “Decentralized Clinical Trials for Drug

This section pertains to the utilization of digital health technologies (DHTs) for remote data acquisition in clinical trials. It is ...

FDA Guidance Clarifies Approach to Decentralized Clinical Trials

The DCT Draft Guidance states that sponsors should ensure that digital health technologies are available and suitable for use to all trial ...

FDA unveils new guidance on use of digital health technologies for ...

FDA unveils new guidance on use of digital health technologies for remote data acquisition in clinical trials ... decentralized clinical trials.”.

Decentralized Clinical Trials: Diversity in Clinical Trials

As we discussed previously, access to telehealth providers and digital health technologies have greatly expanded the types of trial-related ...