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March 4, 2025: PRIM-ER Team Develops Innovative Statistical Techniques for Stepped-Wedge Trials

Rethinking Clinical Trials

Researchers with PRIM-ER, an NIH Collaboratory Trial, published 2 innovative statistical techniques for evaluating intervention effects in stepped-wedge, cluster randomized trials. In stepped-wedge trials, the clusters are randomized into several groups, and all groups start the trial in the control condition.

Trials 167
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Final report says UK infected blood scandal “should have been avoided”  

Pharmaceutical Technology

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

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IPC introduces draft amendment to microbial contamination in non-sterile products in IP 2022

AuroBlog - Aurous Healthcare Clinical Trials blog

In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022.

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GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns

Fierce Pharma

GSK manufacturing review prompts Scynexis to pull Brexafemme, halt trials over contamination concerns esagonowsky Mon, 09/25/2023 - 12:26

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Grand Rounds January 24, 2025: The HEALing Communities Study – 10 Million People, 67 Communities: A Community-Based Cluster Randomized Trial to Reduce Opioid Overdose Deaths (Jeffrey H. Samet, MD, MA, MPH)

Rethinking Clinical Trials

The research team conducted the cluster randomized trial in 67 communities across Ohio, Kentucky, New York, and Massachusetts a total study population of about 10 million. Samet, MD, MA, MPH) appeared first on Rethinking Clinical Trials. HCS is the largest implementation science study funded by NIDA.

Trials 100
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US Woman Receives Revolutionary Brain Implant For OCD And Epilepsy

AuroBlog - Aurous Healthcare Clinical Trials blog

American Amber Pearson used to wash her hands until they bled, terrified by the idea of contamination from everyday items, a debilitating result of her obsessive compulsive disorder (OCD).

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Gilead, following Merck, hits its own safety setback in HIV

Bio Pharma Dive

The FDA has halted all clinical trials testing the injectable form of Gilead's lenacapavir, for fear that incompatibility between the drug and the vials it's held in could cause contamination.