Clinical Trial News
Global COVID-19 Clinical Trial Landscape: Unprecedented Research Response Marked by Coordination Challenges
• A comprehensive analysis of 683 COVID-19 clinical trials revealed an unprecedented surge in research activity during the pandemic's first 100 days.
• The review highlights concerns over trial coordination, with many small trials potentially duplicating efforts and straining research resources.
• Antiviral and antimalarial drugs were the most frequently investigated treatments, with hydroxychloroquine being assessed in over 100 trials.
• The study emphasizes the need for better coordination and data sharing to maximize the efficiency and impact of clinical research during global health crises.
Hydroxychloroquine Fails to Prevent or Treat COVID-19 in Multiple Trials
• A University of Minnesota study found that hydroxychloroquine did not prevent COVID-19 infection in high-risk healthcare workers, with 5.9% of the hydroxychloroquine group and 7.9% of the placebo group developing the virus.
• The NIH's ORCHID trial concluded that hydroxychloroquine provides no clinical benefit to hospitalized adults with COVID-19, with similar health status observed in both hydroxychloroquine and placebo groups after 14 days.
• Both studies reported side effects, such as nausea and upset stomach, but no increased risk of serious cardiac complications from hydroxychloroquine compared to placebo.
• These findings align with other trials, reinforcing that hydroxychloroquine is not an effective treatment for preventing or improving outcomes in COVID-19 patients.
Iterum Therapeutics Presents Phase 3 Sulopenem Data for UTIs at IDWeek 2020
• Iterum Therapeutics presented Phase 3 data for sulopenem in complicated and uncomplicated urinary tract infections (UTIs) at IDWeek 2020.
• The SURE-1 trial demonstrated oral sulopenem's superiority to oral ciprofloxacin in treating uncomplicated UTIs caused by quinolone non-susceptible pathogens.
• SURE-2 trial results for complicated UTIs involved IV sulopenem followed by oral sulopenem, compared to IV ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate.
• Sulopenem, a novel penem anti-infective, is being developed in both oral and IV formulations to combat multi-drug resistant pathogens.
LRRC15-Targeted Antibody-Drug Conjugates Show Promise in Osteosarcoma Treatment
• LRRC15-directed antibody-drug conjugates (ADCs) demonstrate potential as a novel therapeutic approach for osteosarcoma (OS), a bone tumor with high metastasis rates.
• An ADC targeting LRRC15 conjugated to PNU-159682 (PNU) exhibited superior efficacy in inhibiting OS cell growth compared to an ADC with monomethyl auristatin E (MMAE).
• In murine xenograft models, LRRC15-PNU achieved cure rates of 40-100%, highlighting its potential for clinical translation in treating OS.
• The study suggests that inducing LRRC15 expression in low-expressing tumor cells with TGFβ could sensitize them to LRRC15 ADC treatment.
Highlighted Clinical Trials:
AbbVie
Posted 9/18/2015
FDA Approves Remdesivir as First Official COVID-19 Treatment
• The FDA has granted full approval to remdesivir, making it the first and only drug with federal approval for treating COVID-19.
• Remdesivir, an antiviral medication developed by Gilead Sciences, is administered intravenously to hospitalized COVID-19 patients.
• Clinical trials indicated that remdesivir can shorten the recovery time for hospitalized patients by an average of five days.
• Despite conflicting results from the WHO's Solidarity trial, the FDA approval underscores remdesivir's role in COVID-19 treatment.
Comparative Analysis of PARP Inhibitors in BRCA-Mutated Ovarian Cancer Shows Similar Efficacy and Toxicity
• A network meta-analysis of PARP inhibitors (PARPi) in BRCA-mutated ovarian cancer reveals no significant differences in efficacy among various regimens used in upfront or relapsed settings.
• The study assesses the cost-effectiveness of PARPi regimens using the ASCO value framework, indicating similar clinical benefits, toxicity, and net health benefit across different treatments.
• Results suggest that adding bevacizumab to olaparib increases the cost per unit net health benefit compared to olaparib monotherapy in upfront treatment.
• Upfront PARPi regimens demonstrate lower toxicity scores compared to those used in the relapsed setting, providing insights into treatment selection.
Clinical Trial Automation: A Game-Changing Solution for Accelerating Drug Development
• Clinical trial automation technologies are gaining FDA support and proving essential for managing complex data, reducing human error, and streamlining the drug development process.
• Automated systems offer five key benefits including faster trial completion, cost reduction, improved data quality, rapid analysis, and enhanced productivity throughout the clinical trial lifecycle.
• Implementation of automation in critical areas like case report form development, metadata management, and dataset conversion can significantly accelerate time-to-market while ensuring regulatory compliance.
Comprehensive Analysis of Clinical Trials in Pancreatic Cancer Reveals Limited Advances
A detailed analysis of clinical trials for pancreatic ductal adenocarcinoma (PDAC) shows that despite significant funding and research efforts, there have been no paradigm-shifting advances in treatment over the past two decades. The majority of trials focus on chemotherapy combinations, with only a few novel therapies showing promise in phase III trials. The study highlights the urgent need for innovative treatments to improve survival rates for PDAC patients.
Highlighted Clinical Trials:
Stanford University
Posted 8/14/2013
Alliance for Clinical Trials in Oncology
Posted 6/25/2015
AstraZeneca
Posted 12/16/2014
Fudan University
Posted 7/1/2018
Karolinska University Hospital
Posted 6/1/2016
AIO-Studien-gGmbH
Posted 3/31/2018
UNICANCER
Posted 10/23/2015
National Cancer Institute (NCI)
Posted 4/5/2010
Klinikum der Universitaet Muenchen, Grosshadern
Posted 3/1/2012
Eli Lilly and Company
Posted 3/1/2017
1Globe Health Institute LLC
Posted 10/25/2018
Jeffrey Zwicker, MD
Posted 1/1/2015
The Clatterbridge Cancer Centre NHS Foundation Trust
Posted 12/1/2015
Medical University of Graz
Posted 4/1/2018
Centre Oscar Lambret
Posted 10/1/2016
Celgene
Posted 3/28/2014
Memorial Sloan Kettering Cancer Center
Posted 1/30/2018
Memorial Sloan Kettering Cancer Center
Posted 1/1/2015
Eleison Pharmaceuticals LLC.
Posted 4/1/2014
Oslo University Hospital
Posted 9/1/2016
Fudan University
Posted 6/1/2015
SynCore Biotechnology Co., Ltd.
Posted 10/16/2018
University of Erlangen-Nürnberg Medical School
Posted 4/4/2013
Hospital General de Ciudad Real
Posted 7/27/2017
Sumitomo Pharma America, Inc.
Posted 12/1/2016
Cornerstone Pharmaceuticals
Posted 11/9/2018
University of Liverpool
Posted 4/23/2015
Memorial Sloan Kettering Cancer Center
Posted 11/21/2017
Fudan University
Posted 6/1/2015
Wakayama Medical University
Posted 8/1/2016
Krankenhaus Nordwest
Posted 11/1/2014
Health Clinics Limited
Posted 5/23/2022
Assistance Publique - Hôpitaux de Paris
Posted 1/11/2016
Istituto Clinico Humanitas
Posted 7/12/2018
RenovoRx
Posted 3/12/2018
Immunotherapy Improves Survival in Advanced Bladder Cancer Patients
A phase III clinical trial has demonstrated that the immunotherapy drug 'avelumab' significantly improves survival in patients with advanced bladder cancer, marking the first time an immune therapy has shown a survival advantage in this setting. The trial, led by Queen Mary University of London and Barts Cancer Centre, found a 31% reduction in the risk of death and extended median survival by over seven months.
FDA Approves New First-Line Treatment for Head and Neck Cancers
The FDA has approved a new first-line treatment for metastatic or recurrent head and neck cancer, using the immunotherapy drug pembrolizumab, either alone or with chemotherapy. This treatment, developed through research led by Yale's Dr. Barbara A. Burtness, significantly improves survival rates and is less toxic than previous treatments.