The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...

The protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key ...

How AI Is Transforming Trial Design Artificial intelligence has become an integral part of the vision for clinical research ...

The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...

Despite being a cornerstone of cancer treatment advancement, clinical trials remain inaccessible for many patients because of structural, socioeconomic, and systemic barriers. In this ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Artificial intelligence (AI) is transforming how medicines are discovered, but clinical trials are still governed by a structure that has barely evolved: the protocol. Data science, machine learning, ...

The past decade has seen many innovations in clinical trials, including new trial formats 1, novel endpoints 2, new biomarkers and ways of stratifying patients 3, a broader set of data sources such as ...

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance, “Master Protocols for Drug and Biological Product Development”, that echoes and builds on principles that the Agency ...

When you say sponsors should think of their clinical protocols as “data”, what do you mean? For a lot of non-data-scientists, the word “data” typically conjures up images of numbers and spreadsheets.

When discussing the future of clinical trials, people often focus on the promise of exciting new technologies, including artificial intelligence (AI) and predictive modeling. However, even the most ...

In the second of a two-part article, Gabrielle Faure-André and Stéphanie Garçon at Santarelli unpick EPO, UPC and French case law to assess the importance of clinical development timelines in ...