Clinical Trial News
Shingrix Label Updated with Guillain-Barré Syndrome Warning Following FDA Review
• The FDA has mandated a label update for Shingrix, a shingles vaccine, to include a warning about the potential risk of Guillain-Barré Syndrome (GBS).
• Postmarketing studies revealed an elevated risk of GBS within 42 days following Shingrix vaccination, particularly after the first dose, in adults aged 65 and older.
• The FDA emphasizes that while an association between Shingrix and GBS was observed, the available evidence is insufficient to establish a definitive causal relationship.
• Healthcare professionals in Hong Kong will be informed, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
UK PM's 'Greed' Comments Spark Controversy Amid Global Vaccine Distribution Debate
• Boris Johnson faced immediate backlash after attributing UK's COVID-19 vaccination success to "capitalism" and "greed" during a Conservative MP Zoom call, later attempting to retract his comments.
• The controversial remarks came during a sensitive period marking one year of UK lockdown restrictions and amid escalating tensions between the EU and UK over vaccine supply chains.
• The UK's successful vaccination program has delivered first doses to 28 million people, while EU countries have administered 55 million doses total, highlighting the disparity in distribution.
Gamification Emerges as Powerful Tool in Healthcare: From Patient Care to Medical Education
• Gamification is revolutionizing healthcare delivery by improving patient adherence in chronic disease management, with studies showing nearly 50% of chronic disease patients currently not taking medicines as prescribed.
• Digital therapeutics incorporating game elements are gaining significant traction among pharmaceutical companies and healthcare providers, particularly when combined with VR and AR technologies for rehabilitation.
• Medical education is being transformed through gamification, with research indicating improved learning outcomes for healthcare professionals through structured gameplay elements and innovative teaching approaches.
CDK4/6 Inhibitors as Adjuvant Treatment for Hormone Receptor-Positive/HER2-Negative Early Breast Cancer: A Meta-Analysis
A systematic review and meta-analysis evaluates the efficacy and safety of adding CDK4/6 inhibitors to adjuvant endocrine therapy for hormone receptor-positive/HER2-negative early breast cancer, showing a trend towards improved invasive disease-free survival but no significant benefit in distant relapse-free survival, alongside increased adverse events.
Highlighted Clinical Trials:
Novartis Pharmaceuticals
Posted 12/7/2018
Novartis Pharmaceuticals
Posted 6/20/2017
ETOP IBCSG Partners Foundation
Posted 8/27/2019
Savana Leverages AI to Transform EHR Data into Actionable Clinical Insights
• Savana's AI-powered platform analyzes unstructured electronic health record data across 14 countries in five languages, enabling unprecedented access to real-world clinical evidence.
• The company's technology has demonstrated significant value during COVID-19 pandemic through the BigCOVIData study, revealing key insights about disease characteristics and predictive factors.
• Using advanced Natural Language Processing and privacy-preserving techniques, Savana helps pharmaceutical companies and researchers unlock previously inaccessible clinical data while maintaining patient confidentiality.
Libtayo (Cemiplimab) Monotherapy Demonstrates Overall Survival Benefit in Advanced Cervical Cancer
• A Phase 3 trial of Libtayo (cemiplimab) monotherapy in patients with recurrent or metastatic cervical cancer was halted early due to positive overall survival results.
• The trial showed a 31% reduction in the risk of death compared to chemotherapy, regardless of PD-L1 status, marking the first immunotherapy to improve survival in this setting.
• Libtayo monotherapy led to a median survival of 12.0 months versus 8.5 months with chemotherapy, with regulatory submissions planned for 2021.
• The study included women with squamous cell carcinoma or adenocarcinoma, showing survival benefits in both subtypes, with a median age of 51 years.
Advances in Prognostication and Treatment of Polycythemia Vera with Pegylated Interferon and MDM2 Inhibition
Recent studies highlight the efficacy of pegylated interferon (IFN) and MDM2 inhibition in treating Polycythemia Vera (PV), a type of myeloproliferative neoplasm. Pegylated IFN, particularly IFN-α, shows promise in normalizing blood counts, reducing phlebotomy needs, and potentially inducing molecular remissions. Despite its benefits, IFN's side effects limit its use. MDM2 inhibitors, targeting the TP53 pathway, offer a novel approach, with clinical trials demonstrating reduced JAK2V617F allele burdens and improved patient outcomes. These advancements underscore the evolving landscape of PV treatment, emphasizing the need for further research to optimize therapeutic strategies.
Virtual Patient Engagement Reshapes Clinical Trial Design Post-COVID
• The COVID-19 pandemic has accelerated adoption of virtual patient engagement in clinical trials, particularly benefiting those with mobility challenges and disabilities.
• Industry experts emphasize the need for early patient involvement in trial design, from initial concept through development, with companies like Janssen implementing structured engagement touchpoints.
• While digital solutions show promise, researchers must balance virtual approaches with traditional patient care and consider population-specific needs in trial design.
Study Demonstrates Effectiveness of PRECISION Biopsy Strategy in Prostate Cancer Detection
A recent study applied the PRECISION biopsy strategy to a contemporary cohort, showing its effectiveness in reducing unnecessary biopsies and detecting clinically significant prostate cancer, while also identifying characteristics of missed cancers.
Metastatic Patterns and Treatment Response in Prostate Cancer: New Insights into Disease Progression
• Prostate cancer exhibits distinct metastatic patterns, with bone (90%) and lung (46%) being the most common sites, while lymph node metastasis indicates poor prognosis and treatment response.
• Novel imaging techniques like PSMA-PET demonstrate superior sensitivity in detecting metastases compared to conventional methods, enabling earlier intervention and better treatment planning.
• Circulating tumor cells serve as promising biomarkers for monitoring disease progression and treatment response, with ≥5 CTCs per 7.5ml blood correlating with reduced survival in metastatic patients.
Highlighted Clinical Trials:
Endocyte
Posted 5/29/2018
David Palma
Posted 2/22/2019
Duke University
Posted 11/1/2011
Cougar Biotechnology, Inc.
Posted 11/1/2006
Cougar Biotechnology, Inc.
Posted 5/1/2008
University of Dublin, Trinity College
Posted 10/1/2014
UNICANCER
Posted 11/13/2013
NCT01800058Completed
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Posted 1/1/2014
Cougar Biotechnology, Inc.
Posted 6/1/2007
Millennium Pharmaceuticals, Inc.
Posted 10/1/2010
SWOG Cancer Research Network
Posted 9/24/2018
Duke University
Posted 3/1/2014
M.D. Anderson Cancer Center
Posted 3/18/2013