Planning Decentralized Trials

Your approach to running a decentralized clinical trial doesn't have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be ...

Digital Health Trials: Recommendations to Sponsors for Planning ...

CTTI defines decentralized clinical trials (DCTs) as those in which some or all study assessments or visits are conducted at locations other than the ...

Conducting Clinical Trials With Decentralized Elements - FDA

include decentralized elements and trials that do not include decentralized elements. ... division when planning a non-inferiority trial in a DCT setting. B.

SACHRP Recommendations on “Decentralized Clinical Trials for Drug

The plan should consider the decentralized nature of the trial and ensure that adverse events are effectively captured and addressed. It should ...

4 Steps to Decentralize Clinical Trials - ProPharma Group

The earlier you can plan for decentralization in your trial, the more successful you will be in completing the study. You need to determine ...

Decentralized Clinical Trials: 10 Things to Consider When ...

10 Things to Consider When Discussing and Planning a Decentralized Clinical Trial (DCT) Hybrid decentralized clinical trials (DCTs) are facilitating the ...

A Guide For Managing Decentralized Clinical Trials

Regular backups and redundancy plans are essential to prevent data loss. Data Access and Sharing Protocols: Clearly defined policies should be in place ...

Decentralized Clinical Trials - A Comprehensive Synopsis

According to the FDA, decentralized clinical trials (DCTs) are defined by "the decentralization of clinical trial operations where technology is used to ...

Recent FDA Guidance Signals Future Growth for Decentralized ...

... decentralized clinical trials (DCTs). It also reflects the FDA's ... planning a clinical trial with decentralized elements. Use of ...

Clinical trial site readiness for decentralized trials – fitting trials into ...

... plans by trial sponsors. Decentralized methods can also make trials more resilient in supporting business continuity should participants be ...

Decentralized Trials | Penn Medicine Clinical Research

In a decentralized clinical trial (DCT), some or all of a clinical trial's activities occur at locations other than a traditional clinical trial site.

Planning key for successful decentralized studies, says FDA report

The study – published in Therapeutic Innovation and Regulatory Science – looked at trends in drug research and found that although decentralized ...

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 ...

Decentralized Clinical Trials: Perspectives for Clinical Research ...

Sponsors, contract research organizations, vendors, and sites should review and potentially customize each study plan to account for decentralized elements.

What Are Decentralized Clinical Trials? A Complete Guide - Medrio

When communicating with regulatory bodies about plans to decentralize a trial, sponsors should include information about: Local healthcare ...

Applying Systems Thinking to Inform Decentralized Clinical Trial ...

Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment. Ther Innov Regul Sci. 2023 Jun 30. doi: 10.1007/s43441-023-00540-2 ...

FDA Guidance Clarifies Approach to Decentralized Clinical Trials

As a result, the draft guidance recommends that sponsors consult FDA review divisions when planning a non-inferiority trial in a DCT setting.

Lessons Learned for Better Planning of Decentralized Clinical Trials

Our cutting-edge solutions ease the burden on patients and sites by integrating remote monitoring, patient reported outcomes, hybrid or virtual trial models.

Decentralized Trials & Research Alliance

The DCT Tubestop Map is a digital end-to-end process map to support DCT trial planning and execution, with key process steps across the plan, setup, conduct, ...

Oversight and Implementation of Decentralized Clinical Trials

... decentralized and hybrid clinical trials (collectively, DCTs), with a focus on planning and monitoring the trial appropriately. While almost every trial ...