Clinical Trial News
Nivolumab Shows Promise in Advanced Head and Neck Cancer Treatment
- Nivolumab significantly extends survival in advanced head and neck cancer patients compared to chemotherapy, offering a new treatment option.
- A clinical trial demonstrated that 36% of patients treated with nivolumab were alive after one year, versus 17% with chemotherapy.
- Combination therapy of nivolumab and ipilimumab shows potential in reducing tumor size in advanced kidney cancer patients.
- Immunotherapy, like nivolumab, harnesses the immune system to target and destroy cancer cells, with fewer side effects.
Ribociclib Shows Promise in Advanced Breast Cancer Treatment
- Ribociclib, a CDK 4/6 inhibitor by Novartis, significantly improved progression-free survival when combined with letrozole in patients with hormone receptor-positive advanced breast cancer.
- The MONALEESA-2 trial demonstrated a 63.0% progression-free survival rate at 18 months for ribociclib plus letrozole, compared to 42.2% with letrozole alone.
- Common side effects of ribociclib include neutropenia, infection, hair loss, diarrhea, and nausea, with a small percentage of patients experiencing a prolonged QT interval.
- Ribociclib's efficacy and potential high cost raise questions about its accessibility and how it compares to similar drugs like palbociclib.
Strategic Framework for Early Asset Development: Integrating Clinical, Patient, and Commercial Value
- Early-stage pharmaceutical development faces significant challenges due to data gaps and evolving treatment landscapes, requiring teams to predict market conditions 5-10 years ahead.
- Successful asset development demands integration of three key value streams: clinical feasibility, patient benefits, and commercial viability, with emphasis on evidence-based decision making.
- Modern healthcare development increasingly prioritizes patient voice and real-world outcomes, while navigating an increasingly competitive reimbursement landscape with multiple approved therapies.
Verily Partners with Dutch Institutions to Launch Large-Scale Parkinson's Disease Study
- Google's life sciences division Verily collaborates with Radboud University Medical Center and ParkinsonNet to study disease progression in 650 Parkinson's patients using advanced imaging and wearable technology.
- The study aims to understand individual variations in Parkinson's disease progression and treatment response, potentially enabling more personalized treatment approaches for the 10 million affected globally.
- Researchers will utilize real-time data collection through advanced brain imaging, molecular analysis, and wearable devices, with findings to be made freely available to Dutch hospitals and international researchers.
Inspiring Hope Ideathon Launches Global Initiative to Boost Clinical Trial Participation
- INC Research and CISCRP partner to launch the Inspiring Hope Ideathon in Boston, aiming to generate innovative solutions for increasing clinical trial awareness and participation rates.
- With clinical trial participation at just 5% of eligible patients and a current demand for 58 million trial participants, the initiative seeks to address a critical gap in medical research advancement.
- The global competition has attracted over 70 entries worldwide, bringing together diverse stakeholders from technology companies, patient advocacy groups, and healthcare professionals to tackle trial recruitment challenges.
New Immunotherapy for Leukemia Shows Promise in Small Clinical Trial
A novel immunotherapy approach for acute myeloid leukemia (AML) has demonstrated promising results in a small clinical trial, showing a 50% response rate among patients with poor prognoses. The treatment involves 'training' natural killer (NK) cells in the lab to enhance their ability to attack leukemia cells, offering hope for patients with limited treatment options.
FDA Approves Sandoz's Erelzi as First Enbrel Biosimilar in US
- Sandoz's Erelzi (etanercept-szzs) has received FDA approval as the first biosimilar to Amgen's Enbrel, covering all indications of the reference product for inflammatory diseases.
- The approval marks a significant milestone in the US biosimilars landscape, potentially impacting the $5 billion annual US market for Enbrel.
- The biosimilar approval aligns with healthcare cost reduction goals, with IMS Health projecting potential savings of up to $110 billion by 2020 across the US and five largest EU countries.
Comprehensive Guide: Clinical Trial Regulatory Pathways Across 10 Asia-Pacific Nations
- Australia's unique Human Research Ethics Committees (HRECs) system provides trial oversight, with the Clinical Trial Notification (CTN) pathway being the preferred route for conducting clinical trials.
- India requires Drug Controller General approval and local ethics committee clearance, with the new Online Clinical Trial Application and Monitoring System (OCTAMS) streamlining submissions.
- Singapore, Malaysia, and South Korea have established parallel submission processes for regulatory and ethics approvals, with specific requirements for local and imported investigational products.
Study Protocol for a Randomized Controlled, Non-Inferiority Trial on Blended Depression Treatment in Europe
The E-COMPARED project aims to evaluate the clinical and cost-effectiveness of blended depression treatment, combining Internet-based and face-to-face cognitive behavioral therapy (CBT), compared to treatment-as-usual (TAU) across eight European countries. This pragmatic, multinational trial seeks to improve access to cost-effective depression treatments, addressing the significant societal and economic burden of depression.
Highlighted Clinical Trials:
Institut National de la Santé Et de la Recherche Médicale, France
Posted 9/1/2015
University of Social Sciences and Humanities, Warsaw
Posted 6/1/2015
Linkoeping University
Posted 2/1/2015
Universitat Jaume I
Posted 2/1/2015
University of Bern
Posted 3/1/2015
Precision Oncology Medicine: The Clinical Relevance of Patient Specific Biomarkers Used to Optimize Cancer Treatment
Precision medicine in oncology leverages patient-specific clinical features and genomic-based diagnostics to optimize cancer treatment. This approach utilizes companion diagnostics for specific drug-target pairs, germline mutations affecting drug response, and multigene expression-based assays to guide treatment decisions. The article highlights the importance of biomarkers in predicting drug response, toxicity, and the shift towards a comprehensive, multi-gene approach in cancer therapy.
Highlighted Clinical Trials:
Novartis Pharmaceuticals
Posted 7/24/2014
Pfizer
Posted 10/10/2013
Hoffmann-La Roche
Posted 4/12/2012
Institut Curie
Posted 10/1/2012
M.D. Anderson Cancer Center
Posted 6/2/2011
QuantumLeap Healthcare Collaborative
Posted 3/1/2010
Novartis Pharmaceuticals
Posted 3/12/2014
European Organisation for Research and Treatment of Cancer - EORTC
Posted 9/1/2012
UNICANCER
Posted 4/23/2014
National Cancer Institute (NCI)
Posted 2/8/2011
Novartis Pharmaceuticals
Posted 3/29/2013
Novartis Pharmaceuticals
Posted 8/1/2013
National Cancer Institute (NCI)
Posted 2/11/2015
National Cancer Institute (NCI)
Posted 8/17/2015
Novartis Pharmaceuticals
Posted 9/17/2014
NCT02154490Completed
SWOG Cancer Research Network
Posted 7/8/2014
Novartis Pharmaceuticals
Posted 8/25/2014
American Society of Clinical Oncology
Posted 3/14/2016
Hoffmann-La Roche
Posted 8/19/2014
National Cancer Institute (NCI)
Posted 1/7/2014
UNICANCER
Posted 4/7/2014
ECOG-ACRIN Cancer Research Group
Posted 3/23/2015
Novartis Pharmaceuticals
Posted 2/1/2014
National Cancer Institute (NCI)
Posted 9/26/2014
University of Birmingham
Posted 5/1/2015