Decentralized Clinical Trials in Early Drug Development

Decentralized Clinical Trials in Early Drug Development—A ...

A report is available recommending EU-level actions to improve the set-up and conduct of clinical trials during public health emergencies. The recommendations ...

Decentralized Clinical Trials: A Balancing Act | Citeline

This updates an FDA guidance issued in 2020 during the pandemic and follows a set of DCT recommendations issued by the European Medicines Agency ...

Decentralized Clinical Trials Defined: A Guide - GoodRx

Decentralized Clinical Trials: Will Location-Specific Studies Be a Relic of The Past? · A decentralized clinical trial (DCT) is a study that's ...

FDA Issues Draft Recommendations for Implementing Decentralized ...

The US Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance.

ASCO's Call-to Action: Advancing Patient-focused ... - ADC Review

Required adaptations to clinical trial design and execution, implemented during ... Decentralized clinical trials for drugs, biological products, ...

Data-Driven and Technology-Enabled Trial Innovations Toward ...

DCT, decentralized clinical trial; DHT, digital health technology; ECG, electrocardiographic; FDA, Food and Drug Administration. Open table in a new tab.

DECENTRALIZED TRIALS & RESEARCH ALLIANCE (DTRA ...

“Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives,” said Craig ...

No Place like Home How to Make Decentralized Clinical Trials a ...

... decentralized studies – also known as virtual or siteless trials – in an effort to keep drug development programs on course during COVID-19. The strategy ...

Decentralized clinical trials (DCTs): A few ethical considerations

The CoViD-19 pandemic has caused a significant increase in DCT: a survey shows that 76% of pharmaceutical companies, device manufacturers, and ...

Enhancing Clinical Trial Models: The Power of Decentralized Trials

Decentralized clinical trials were on the rise long before COVID-19, but their success in keeping drug development programs on track during ...

The Digital Platform and Its Emerging Role in Decentralized Clinical ...

This viewpoint summarizes the current role of digital platforms in supporting decentralized trial activities, including a discussion of the potential benefits ...

Decentralized Clinical Trials for Rare Disease Treatments | Avalere

... research, advancing drug development and improving patient experiences. Background. In rare disease (RD) research, traditional site-bound trials ...

How Decentralization is Becoming the Norm in Clinical Trials

Experts consider how decentralized clinical trials will change in the future. Find out more with The Medicine Maker.

Regulatory readiness to facilitate the appropriate use of innovation ...

A selection of completed decentralized clinical drug trials. Clinical trial acronym, Clinical trial register number, Clinical trial aim, Full or hybrid DCT ...

FDA Guidance May Bolster Confidence in Decentralized Clinical Trials

DCTs allow sponsors such as pharmaceutical companies to reach a larger and more diverse pool of potential participants, Zucker agreed. Such a ...

Walgreens New Decentralized Clinical Trials Model in Action

The 2024 SCOPE Summit, a pivotal event in clinical trials, showcased innovative strategies to transform patient recruitment and trial ...

Early Clinical Development - Phase I Trials - IQVIA

Find out how IQVIA can help you track the impact of new drugs and establish proof of concept faster with innovative early clinical development strategies.

Decentralized Clinical Trials in Oncology: Are We Ready for a Virtual ...

... clinical trial and is a crucial step in trial enrollment. ... Decentralized Clinical Trials in Early Drug Development—A Framework Proposal. Article. Full-text ...

The Introduction of AI Into Decentralized Clinical Trials

To address the need for a risk-based regulatory framework that promotes innovation and protects patient safety, the Food and Drug Administration ...

Oversight and Implementation of Decentralized Clinical Trials

Working with a multi-stakeholder task force, the first initiative of this project addresses the ethical review of DCTs, focusing on how DCTs differ from ...