News

Industry leaders share their perspectives on the guidance and how it will affect sponsors moving forward.

The combination of islatravir (Merck) and lenacapavir (Gilead) demonstrated high efficacy in maintaining a 94.2% viral suppression rate in virologically suppressed adults with HIV after 48 weeks of treatment in a Phase II trial.

In this video interview with ACT editor Andy, Studna, Silvio Galea, chief data & analytics officer, WCG, touches on the usability of clinical technology.

In this video interview with ACT editor Andy, Studna, Silvio Galea, chief data & analytics officer, WCG, highlights challenges with patient data from an operational perspective.

From design and trial start-up to conduct and analysis, there is enormous potential for applications of artificial intelligence within clinical trials to have a profound impact on human health.

Merck's investigational monoclonal antibody, clesrovimab, shows significant efficacy in reducing respiratory syncytial virus-related infections and hospitalizations in infants, with a favorable safety profile.

In this video interview with ACT editor Andy, Studna, Silvio Galea, chief data & analytics officer, WCG, discusses the lack of awareness surrounding clinical research.

In a rare disease space that faces challenges in measurement quality, these technologies can enable the use of real-world data and improve study timelines.

The combination of Opdivo (nivolumab) plus chemotherapy significantly improved progression-free survival compared to Adcetris (brentuximab vedotin) plus chemotherapy in patients with advanced stage Hodgkin lymphoma, based on findings from the Phase III S1826 trial.

Real-world data presented at IDWeek 2024 show Apretude (cabotegravir long-acting) is more than 99% effective in preventing HIV infection, with high adherence rates, reduced stigma and anxiety, and broad acceptability.

As industry clinical trial partners seek greater patient diversity and operational efficiencies in drug development, our October issue of Applied Clinical Trials explores some of the related outsourcing methods that are emerging.

Preliminary data from the Phase III IMforte trial show the combination of Zepzelca (lurbinectedin) plus Tecentriq (atezolizumab) significantly improved overall survival and progression-free survival in patients with extensive-stage small cell lung cancer.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how the guidance should prompt better-designed oncology trials and greater diversity.

A data-fueled framework for sponsors and CROs in navigating this shifting terrain.

Data from the RAINBOWFISH trial shows early treatment with Evrysdi (risdiplam) in pre-symptomatic infants with spinal muscular atrophy (SMA) leads to significant motor milestone achievements, such as standing and walking, as well as cognitive development typical of non-SMA children, without the need for permanent ventilation.

Overcoming this bias—which affects everything from trial design to data collection—is a critical obligation of clinical research stakeholders.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, touches on challenges that may be created by the guidance such as meeting multiple regulatory requirements.

Using surveys to collect various viewpoints on eConsent from ethics, sponsors, and vendors.

Tremfya (guselkumab) demonstrated superior endoscopic remission rates in both Crohn disease and ulcerative colitis, including biologic-naïve and biologic-refractory patients, according to Phase III clinical trial data.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discusses how sponsors will need to plan ahead even further for their oncology trials.

Arexvy, recently approved for adults 50 through 59 years of age at increased risk, succeeds in trial of adults aged 60 and older through multiple respiratory syncytial virus seasons.

In this video interview with ACT editor Andy Studna, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, highlights how FDA’s multiregional clinical trials in oncology guidance encourages more diverse site locations and patient populations.

Talzenna (talazoparib) with Xtandi (enzalutamide) produced a statistically significant improvement in overall survival among patients with metastatic castration-resistant prostate cancer, regardless of mutation status, making it the first combination of a PARP inhibitor and ARPI to achieve these results.

In this video interview with ACT editor Andy Studna, Kashoki, SVP, global head of regulatory strategy, discusses the new draft guidance and its emphasis on proactive planning.

For advancement, pharma must focus on streamlining clinical operations.

KEYNOTE-689 trial shows Keytruda (pembrolizumab) produced significantly improved event-free survival and major pathological response in patients with resected, locally advanced head and neck squamous cell carcinoma, marking the first Phase III trial to show meaningful results with an anti-PD-1 therapy in both the neoadjuvant and adjuvant settings.

The role of the clinical research associate may be key in addressing challenges around the adoption of digital tools.

Twice-yearly lenacapavir, a long-acting HIV-1 capsid inhibitor, reduced HIV infections by 96% in the Phase III PURPOSE 2 trial while showing superior efficacy over daily Truvada.