Clinical Research Focus. 29th Edition

Celebrating Clinical Trials Day: Highlighting the Outside-the-Box Studies that Push the Boundaries

May 20th is Clinical Trials Day, a time to honor the vital role clinical research plays in advancing medical science. While this day traditionally highlights the rigorous and essential work behind clinical trials, we thought it would be fun to celebrate in a different way – by showcasing some of the most unconventional, surprising, and unusual clinical studies conducted in recent years.

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FDA Clarifies Distinctions in Device Remanufacturing and Maintenance in New Guidance

The FDA has issued final guidance to distinguish between “remanufacturing” and routine servicing of medical devices. This guideline aims to clarify and ensure the maintenance of device safety and effectiveness, following comprehensive reviews and public feedback. It outlines industry best practices and labeling recommendations to support the continuous availability of high-quality medical devices in healthcare.

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Deep dive into Clinical Trials Specifics in Türkiye

Türkiye is becoming an attractive destination for clinical trials due to its robust healthcare infrastructure and a large pool of treatment-naive patients. In our latest video interview, CEO of Cromos Pharma, Vlad Bogin, MD, FACP, speaks with Seniz Sagol Tuysuz, the Country Head of Cromos Pharma in Türkiye. They explore why Türkiye is emerging as a biotech hub, discussing the clinical trial landscape, regulatory environment, quality and safety measures, patient recruitment, and best practices for successful trials.

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NIH Study Reveals Higher Levels of Cognitive Impairment in Older American Indians

New NIH-funded research indicates that cognitive impairment and dementia are significantly more prevalent among older American Indians than previously understood, affecting 54% of studied individuals. This finding underscores the necessity for focused health strategies within this population.

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Ukraine Strives to Remain a Hub for Clinical Trials Despite Conflict

In the last couple of decades Ukraine had established itself as a thriving hub for clinical trials, especially recognized for its advancements in oncology research. Before the conflict began, the country was a beacon for international medical research, attracting increasing number of studies each year. However, the onset of the war significantly slowed this activity, with the number of new trials plummeting from around 300 annually to just 9 in 2022.

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NIH Consortium Maps Gene Regulation in the Human Brain

NIH-funded research has created detailed maps of gene regulation networks in the human brain, using tissue from over 2,500 donors. This groundbreaking work, which spans 15 published papers, enhances understanding of genetic factors in mental disorders like schizophrenia and depression, providing new avenues for therapeutic development.

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New Phase 2a Trial Highlights Potential of p75NTR Modulation in Alzheimer’s Diseasev

A recent trial explores the effects of LM11A-31, a p75 neurotrophin receptor modulator, on Alzheimer’s disease, showing promise in slowing disease progression without significant cognitive impact. This 26-week, randomized, placebo-controlled trial tested safety and preliminary efficacy, revealing potential for larger-scale studies due to favorable safety outcomes and indicators of biological activity.

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AstraZeneca to Open $1.5 Billion ADC Facility in Singapore

AstraZeneca plans to establish a $1.5 billion antibody drug conjugate (ADC) manufacturing facility in Singapore, aiming for zero carbon emissions. The facility, starting operations in 2029, will support its global ADC portfolio and enhance precision cancer treatments.

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Subtypes of Triple-Negative Breast Cancer: Response to Chemotherapy

A study analyzed the response of 187 triple-negative breast cancer (TNBC) patients to neoadjuvant chemotherapy, classifying tumors using immunohistochemistry. Different subtypes showed varied responses, with basal-like immune-activated tumors achieving the highest pathological complete response rates. The findings emphasize the importance of subtype-specific treatment strategies in TNBC.

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