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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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Managing Opportunities and Risks in Generative AI Use for Clinical Research

PPD

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. No clear validation metrics: Performance is difficult to benchmark in regulated, high-stakes domains.

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Advancing and Safeguarding Clinical Research for a Better Tomorrow

Advarra

Institutional review boards (IRBs) play a crucial role in the ever-evolving field of clinical research. Innovations in fields such as immunotherapy, cancer and chronic diseases owe their existence to clinical trials, which judiciously test and evaluate safety and efficacy.

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The Value of Clinical Research

Advarra

Clinical research is a vital driver of medical progress. Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. It is the foundation of medical innovation.

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The AI model that is changing clinical trial design

Drug Target Review

They offer patient-specific outcome predictions, generated using machine learning models trained on real historical clinical data. Chief Executive Officer Steve Herne has spent more than 25 years in clinical research, with senior roles at WCG, Bioclinica and Covance. Integration is straightforward,” Herne notes.

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Kaempferol exerts antioxidant effects in age?related diminished ovarian reserve by regulating the HSP90/NRF2 pathway

Chemical Biology and Drug Design

Kaempferol exerted antioxidant effects in AR-DOR by inhibiting Hsp90 to up-regulate Nrf2. In this study, 36 volunteers and 78 DOR patients (37 patients with EXD treatment) were enrolled in the clinical research. This study provides a theoretical basis for the clinical application of kaempferol in AR-DOR.