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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.

Imfinzi (durvalumab; AstraZeneca) plus gemcitabine and cisplatin was found to double the overall survival rate after three years in patients with advanced biliary tract cancer.

NCI-designated research and treatment center, City of Hope, in Duarte, CA will participate in UMN’s ongoing Phase I study.

Columvi with gemcitabine and oxaliplatin showed the potential to improve survival in patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant.

Following a webinar on what the clinical trials space will look like for the remainder of 2024, ACT caught up with Getz and Murphy to discuss their biggest takeaways.

Multicenter, open-label, 156-week extension trial finds that Qulipta (atogepant) reduced migraine days and acute medication use in patients with chronic or episodic migraine.

Streamlining electronic clinical outcome assessment and patient-reported outcome processes can aid in decreasing timelines.

In the fifth and final part of this video interview with ACT editor Andy Studna, Stephen Pyke, chief clinical data and digital officer, Parexel, highlights the importance of human oversight when using artificial intelligence to aid in decision making.

The current clinical development model is shifting toward a generative AI-augmented proactive approach supported by real-world data for real time evidence.

A full summary of the acute adverse effects of psilocybin in the treatment of depression and anxiety is vital for health care providers to provide effective patient counseling.

In part 4 of this video interview with ACT editor Andy Studna, Stephen Pyke, chief clinical data and digital officer, Parexel, spotlights the importance of considering the experience of patients when integrating artificial intelligence as well as some of the benefits they will see from it.

In part 3 of this video interview with ACT editor Andy Studna, Stephen Pyke, chief clinical data and digital officer, Parexel, discusses the importance of collaboration and data sharing in advancing the use of technology.

Following a webinar on the use of a medical device in a migraine clinical trial, Mowlem caught up with ACT to discuss her biggest takeaways and what she is currently seeing in the digital trials space.

Findings from the Phase I/II KRYSTAL-1 trial of Krazati (adagrasib) plus cetuximab showed promising clinical activity and tolerable safety in patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Improving the site-sponsor relationship can get trials off on the right foot and on a path for success.

Findings from MONeT clinical trial show positive safety and efficacy of Abrysvo in individuals aged 18 to 59 years with an increased risk of developing severe respiratory syncytial virus-associated lower respiratory tract disease.

In part 2 of this video interview with ACT editor Andy Studna, Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes.

Systematic review of research articles sought to identify and characterize different technologies being used in clinical studies.

In part 1 of this video interview with ACT editor Andy Studna, Stephen Pyke, chief clinical data and digital officer, Parexel, gives a broad overview of the use of artificial intelligence in clinical development and how regulatory bodies are viewing it.

In the EMPACT-MI trial, Jardiance produced a 10% relative risk reduction in the primary composite endpoint of time to first hospitalization for heart failure or all-cause mortality.