News

Phase III KEYNOTE-522 trial data show Keytruda (pembrolizumab) plus chemotherapy lowered the risk of death by 34% compared to chemotherapy alone in patients with high-risk early-stage triple-negative breast cancer.

In an interview with Nico Saraceno at DPHARM 2024, Munther Baara, VP strategy and innovation, EDETEK touches on the features an effective AI/ML model can provide and how they benefit data management in trials.

Niktimvo (axatilimab) gained FDA approval in August 2024 to treat graft-versus-host-disease in patients who did not achieve a response to at least two prior lines of systemic therapy.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the potential for artificial intelligence in clinical trial decision-making and enrollment.

Final guidance suggests sponsors select two doses for Phase II trials with additional data requirements.

Cabozantinib (Cabometyx, Cometriq) shows potential as a new standard of care for patients with advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic neuroendocrine tumors in Phase III CABINET trial.

In an interview with Nico Saraceno at DPHARM 2024, Pellegrino highlights current challenges she is seeing in patient recruitment and the use of technology to identify patients.

Session provides insight as to how to boost interoperability and expand the middleware on a global scale.

Results from the the Phase III NIAGARA trial show Imfinzi (durvalumab) is the first immunotherapy regimen to significantly extend overall survival in patients with muscle-invasive bladder cancer.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, director, clinical operations, Rho, offers her thoughts on key considerations that sponsors should be mindful of during the decision-making process with the timeline of a clinical trial.

In an interview with Nico Saraceno at DPHARM 2024, Smith discusses how predictive modeling and community engagement can increase diversity.

According to the session panelists, tackling challenges and finding efficiencies is imperative for success.

Kesimpta (ofatumumab) demonstrates efficacy lowering disability progression and disease activity in different populations of patients with relapsing multiple sclerosis.

The presentation expresses the importance of putting the patient at the center of patient recruitment.

Session reveals how organizations can implement DCTs into their clinical trial planning and execution processes.

DESTINY-Breast12 trial results show Enhertu (trastuzumab deruxtecan) produced substantial overall and intracranial clinical activity in patients with HER2-positive metastatic breast cancer and brain metastases, supporting its potential use as a second-line treatment.

Multi-region clinical trials can provide for varied results, but may not paint a full picture for a specific population.

Results of a Phase II study of ponsegromab showed significant improvements in body weight, muscle function, and overall symptoms for patients with cancer cachexia, offering hope for a new targeted treatment.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sonia Lwoff, director, clinical operations, Rho, discusses the importance of CROs building strong relationships with trial sites.

Data from the Phase III HIMALAYA trial found the combination of Imfinzi plus Imjudo reduced the risk of death by 24% compared to sorafenib in patients with unresectable hepatocellular carcinoma.

Ten-year results from the Phase III CheckMate -067 trial reveal that the combination of Opdivo and Yervoy significantly improves overall survival in patients with advanced melanoma, offering the longest-reported survival data in this population.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, discusses new strategies that companies can implement to properly shift to the new EU clinical trial framework.

Amid the steady introduction of new tech and data advances in study conduct, the September issue of Applied Clinical Trials explores the evolving regulatory landscape governing these efforts and what companies are doing to remain compliant.

Phase III ADRIATIC trial results show that Imfinzi (durvalumab) significantly improves overall survival and progression-free survival compared to placebo in patients with limited-stage small-cell lung cancer.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, offers her thoughts on what EU clinical trial regulations companies need to be the most aware of.

An overview of the advantages of implementing AI into clinical development and the obstacles that prevent its widespread adoption.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Xandra Neuberger, associate director, regulatory affairs, PharmaLex, discusses the goals of the EU clinical trial regulation.

A look at the insights and implications surrounding the agency's recommendations on using RWE from electronic health records and medical claims data.