The etiology of type 1 diabetes (T1D) foreshadows the pancreatic islet beta‐cell
autoimmune pathogenesis that heralds the clinical onset of T1D. Standardized and …

The development of medical products that can delay or prevent progression to stage 3 type
1 diabetes faces many challenges. Of note, optimising patient selection for type 1 diabetes …

Clinical trials seeking type 1 diabetes prevention are challenging in terms of identifying
patient populations likely to progress to type 1 diabetes within limited (ie, short‐term) trial …

A rich pipeline of therapeutic candidates is advancing for Parkinson's disease, many of
which are targeting the underlying pathophysiology of disease. Emerging evidence …

In this chapter, the authors summarize the current knowledge of possible trigger (s) of p‐cell
autoimmunity and factors affecting the progression to the clinical onset in individuals who …

Whereas islet autoantibodies (AAs) are well‐established risk factors for developing type 1
diabetes (T1D), there is a lack of biomarkers endorsed by regulators to enrich clinical trial …

To the Editor: The Center for Drug Evaluation and Research at the US Food and Drug
Administration (FDA) recognises both the need for drugs and biologics that can delay or …

This chapter will review existing guidance documents and precedents related to real-world
evidence provided by major regulatory agencies across the world. We will first outline the …

Точная этиология и механизмы, провоцирующие развитие сахарного диабета 1-го типа
(СД1), до конца не изучены, но появляется всё больше научных данных …