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Beyond blood tests: The evolution of digital biomarkers in clinical research

Drug Discovery World

With a staggering 450,000 clinical trials 3 registered globally to address these pressing health issues, and an average failure rate of 90% 4 , the call to accelerate and revolutionise clinical research is paramount. They mark a significant shift in clinical research, utilising technology to capture real-time patient data.

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How organoids can redefine pre-clinical research

Drug Target Review

Organoid technologies are becoming an invaluable solution for preclinical research, with the ability to augment the development of personalised medicine, drug discovery and gene therapies. The derived drug was given to both patients, to which researchers report the patients saw significant improvement. 2023 May;30(5):571–91.

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Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research

Vial

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? billion in 2022 and is projected to reach US$10.2

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GAO Report on Clinical Research Inspections Encourages FDA to Care for its Clinical Inspection Program

FDA Law Blog: Biosimilars

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022.

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DDW Highlights: 21 August 2023

Drug Discovery World

Diana Spencer has chosen news stories this week which all discuss pre-clinical research studies that could have a huge impact on our therapeutic approach to several hard-to-treat diseases, helping to overcome drug-resistance and make treatments more targeted in the future.

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Navigating the Challenges in Clinical Research for Hepatitis C Therapies

Vial

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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Vaccine monitoring crucial as SARS-CoV-2 evolves, say researchers

Drug Discovery World

UK researchers have highlighted the importance of continued surveillance of emerging SARS-CoV-2 variants and vaccine performance as the virus continues to evolve. The researchers found that both vaccines generated neutralising antibodies against the most recent strain of Omicron, BA.2.86. strains after their booster vaccination.

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