News

Phase III KEYNOTE-811 trial data show Keytruda (pembrolizumab) combined with trastuzumab and chemotherapy achieved the primary endpoint of overall survival in the first-line treatment of patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

In part 1 of this video interview with ACT editor Andy Studna, Rohit Nambisan, CEO & founder of Lokavant discusses use cases for artificial intelligence in clinical trials and how it can enhance patient centricity.

As adoption increases, regulatory bodies are becoming more involved in the oversight of artificial intelligence.

Data from the Phase III STRIDE-10 trial showed V116 produced immune responses against the serotypes responsible for the majority of adult invasive pneumococcal disease.

New amendment explicitly states that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act.

Despite the significance offered by AI to pharmaceutical companies, there are several challenges that must be overcome for successful integration of tech-based tools.

Under new multi-year strategic partnership, Parexel will utilize Palantir’s artificial intelligence platform.

Enhertu, a HER2-directed antibody-drug conjugate, showed a clinically meaningful survival benefit in progression-free survival among patients with HR-positive, HER2-low metastatic breast cancer.

Phase II/III COMPANION-002 trial shows promise of CTX-009 in combination with paclitaxel for patients with metastatic or locally advanced biliary tract cancer.

In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.

Analysis of randomized clinical trial for migraine sought to determine whether there were differences between outcomes from patients assigned to roles and those as healthy controls.

Rinvoq (upadacitinib) shows efficacy in both itch resolution and skin clearance in the treatment of patients with atopic dermatitis.

In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.

Cross-sectional comparative study of over 36,000 patients with diabetes found differences in the two groups, suggesting a need for broader patient criteria in trials.

Felix addresses a variety of topics around artificial intelligence including challenges, streamlining data management, and human intervention.

Data from part one of the Phase III RUBY trial show Jemperli (dostarlimab) plus chemotherapy produced a statistically significant and clinically meaningful survival benefit in patients with primary advanced or recurrent endometrial cancer, including those with mismatch repair proficient/microsatellite stable tumors.

A representative sample patient population that accurately reflects the overall population is vital to establish the safety and efficacy of a drug.

Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.

In part 2 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses best practices for understanding specific therapeutic areas and deploying an effective eCOA strategy.

In part 1 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA touches on how the use of clinical outcome assessments differs across therapeutic areas.

Morbidity and Mortality Weekly Report finds that the original monovalent COVID-19 vaccines were associated with fewer hospitalizations, particularly within the first four months after vaccination, but the duration of protection from the original vaccine diminished over time.

Factors that contribute to Japan's prominent position in the rapidly evolving field of digital therapeutics and why it matters to the global life sciences industry.

Meta-analysis shows neoadjuvant immune checkpoint inhibitors with chemotherapy improves two-year event-free survival and pathologic complete response in patients with early-stage non–small cell lung cancer.

Survey study of eight biopharma companies aimed to identify how often technology is being used in cancer trials.

Whether unstructured patient diaries will be part of future clinical trials depends on three main factors, including answers around added value.

Data from an open-label extension study show that administration of first-line Kesimpta for up to six years in treatment-naïve patients recently diagnosed with relapsing multiple sclerosis led to fewer relapses, suppressed MRI lesion activity, and fewer disability worsening events.

The concept of sludge provides an invaluable lens for clinical research professionals in identifying and mitigating unnecessary friction and bottlenecks.

GSK’s gepotidacin achieved a 92.6% microbiological success rate in its third positive pivotal trial.

Phase III SURMOUNT-OSA trial data shows promise of tirzepatide, marketed as Zepbound and Mounjaro, treating the underlying disease in patients with moderate-to-severe obstructive sleep apnea.

Reviva Pharmaceuticals and the FDA have reached alignment on the 4-week global registrational study.