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September 30, 2024

TNF-α inhibitors for type 1 diabetes: exploring the path to a pivotal clinical trial

Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction...

October 8, 2024

Flexible approaches to eCOA administration in clinical trials: The site perspective

Estelle Haenel, Celeste A. Elash, Katie Garner, Megan Turner, Scottie KernAbstract Electronic Clinical Outcome Assessment (eCOA) C

September 27, 2024

Conceptualizing meaningful between-group difference in change over time: a demonstration of possible viewpoints

Purpose Determining if group-level differences in health outcomes are meaningful has recently been neglected...

August 1, 2024

Advancing Rare Disease Measurement With The Rare Disease COA Resource

It is estimated that more than 350 million people worldwide live with a rare disease.

July 29, 2024

A Modern Curriculum for Training Scientists in Model-Informed Drug Development: Progress Report on FDA Grant to Train Regulatory Scientists

C-Path and experienced private sector partners collaborated with global health organizations to create didactic video materials...

June 12, 2024

Using a smartwatch and smartphone to assess early Parkinson’s disease in the WATCH-PD study over 12 months

Digital measures may provide objective, sensitive, real-world measures of disease progression in Parkinson’s disease (PD).

May 28, 2024

Accelerating healthcare innovation: the role of Artificial intelligence and digital health technologies in critical path institute’s public-private partnerships

Artificial Intelligence (AI) and Digital Health Technologies (DHTs) are radically transforming drug development. The FDA and EMA..

April 22, 2024

Unlocking the Capabilities of Large Language Models for Accelerating Drug Development

Recent breakthroughs in natural language processing (NLP), particularly in large language models (LLMs), offer substantial...

February 1, 2024

A biological definition of neuronal α-synuclein disease: towards an integrated staging system for research

Parkinson's disease and dementia with Lewy bodies are currently defined by their clinical features, with α-synuclein pathology...

December 14, 2023

Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

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