research Industry update: the latest developments in the field of therapeutic delivery, July 2018
New partnerships, clinical trials, and drug approvals marked progress in therapeutic delivery in July 2018.
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research Development of Uniform Protocol for Alopecia Areata Clinical Trials
A standard protocol for alopecia areata clinical trials was created to improve consistency and encourage more research.
research Scientific Validation of "Clinically Proven" Claims: Compliance Focused and Global Regulatory Insights
"Clinically proven" claims require strict testing and adherence to guidelines for trust and authenticity.
research Supplementary Material for: Patient Preferences: Results of a German Adaptive Choice-Based Conjoint Analysis (Market Research Study Sponsored by Eli Lilly and Company) in Patients on Palliative Treatment for Advanced Breast Cancer
Patients with advanced breast cancer prioritize quality of life, overall survival, and progression-free survival in treatment decisions.
research The global clinical landscape of human-derived extracellular vesicles: an analysis based on ClinicalTrials.gov (2010–2025)
Extracellular vesicles are important for disease treatment and monitoring.
research Select the most correct answers – multiple answers possible for questions 1–11
Medical practitioners need to understand basic statistics to properly evaluate clinical trials and avoid unethical designs.
research The ethics of placebo-controlled trials: Methodological justifications
research Blinding in Placebo-Controlled Trials
The conclusion is that maintaining blinding in clinical trials is crucial for reliable results.
research Non-clinical safety evaluation and risk assessment to human of aleglitazar, a dual PPAR α/γ agonist, and its major human metabolite
Aleglitazar and its major metabolite are safe enough to proceed to Phase 3 clinical trials.
research The BJUI 's clinical trials initiative
The BJUI supports clinical trials as key for unbiased medical evidence and works to enhance their design, reporting, and discussion.
research Strategy for Generating Blinded Evidence for Single-Arm Trials with External Controls Using Expert Review of Home Video
A new method uses expert reviews of home videos to objectively assess children's developmental milestones in single-arm trials.
research Evaluating statistics in clinical trials: Making the unintelligible intelligible
Doctors need to understand statistics to properly evaluate clinical trials for patient care.
research Empirical evidence of observer bias in randomized clinical trials: updated and expanded analysis of trials with both blinded and non-blinded outcome assessors
Non-blinded assessors tend to overestimate effects in trials by about 29%.
research Alisertib is active as single agent in recurrent atypical teratoid rhabdoid tumors in 4 children
Alisertib was found to be an effective and tolerable treatment for children with recurrent brain tumors.
research DRUG NEWS
The FDA approved a new breast cancer treatment, found flu shots may reduce heart risks, questioned the safety of fast-tracked drug approvals, showed statins don't help with certain pneumonia, and approved a new dementia imaging agent.
research America - A Diversity of Life Styles.
The drug showed promise in treating renal cell carcinoma with manageable side effects.
research Numerical Methods for Decision-Making in Clinical Care: Where to Now?
Hyperbaric oxygen therapy shows promise for multiple sclerosis, but skepticism and funding issues limit tech use in clinics, and outdated single-drug cancer treatments may cause unnecessary side effects.
research Discussion of “A hybrid phase I‐II/III clinical trial design allowing dose re‐optimization in phase III” by Andrew G. Chapple and Peter F. Thall
The new clinical trial design is promising but needs real-world trials to test its effectiveness and possible enhancements.
research Reporting on Adverse Clinical Events
Monitoring for adverse effects in clinical treatments is crucial.
research Exploring the Potential Routine Use of Electronic Healthcare Record Data to Strengthen Early Signal Assessment in UK Medicines Regulation: Proof-of-Concept Study
Using electronic health records can help identify drug side effects but has some limitations.
research Patient Preferences: Results of a German Adaptive Choice-Based Conjoint Analysis (Market Research Study Sponsored by Eli Lilly and Company) in Patients on Palliative Treatment for Advanced Breast Cancer
Patients prioritize quality of life, overall survival, and progression-free survival in treatment decisions for advanced breast cancer.
research Multicentric parallel phase II trial of the polo-like kinase 1 inhibitor BI 2536 in patients with advanced head and neck cancer, breast cancer, ovarian cancer, soft tissue sarcoma and melanoma. The first protocol of the European Organization for Research and Treatment of Cancer (EORTC) Network Of Core Institutes (NOCI)
BI 2536 had limited effectiveness against several advanced cancers and caused significant side effects.
research Reporting on Adverse Clinical Events
Different medications can cause serious side effects in some people.
research The difficulty of finding ‘healthy’ volunteers
Most people who volunteered for a health study had medical issues, showing the need for careful screening before trials.
research Efficacy and safety of proxalutamide (GT0918) in severe or critically ill patients with COVID-19: study protocol for a prospective, open-label, single-arm, single-center exploratory trial
The trial will test if proxalutamide is safe and effective in reducing death in severe COVID-19 patients.
research Safety and efficacy of ALRV5XR in women with androgenetic alopecia or telogen effluvium: A randomised, double-blinded, placebo-controlled clinical trial
ALRV5XR significantly improves hair density in women with hair loss and is well-tolerated.
research Safety and efficacy of ALRV5XR in men with androgenetic alopecia: A randomised, double-blinded, placebo-controlled clinical trial
ALRV5XR effectively increases hair density in men with androgenetic alopecia without adverse effects.
research Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study
Healthcare claims databases can help monitor drug safety, but may report adverse events differently than direct surveillance.
research Poster 252 Patient Registry of Outcomes in Spasticity Care
The data suggests that dosing differences can help manage spasticity in patients with upper motor neuron dysfunction.
research Four-year experience with the preferential derivation care model for multidisciplinary care in patients with psoriasis and psoriatic arthritis
The care model improved timely diagnosis and treatment for psoriasis and psoriatic arthritis.