News

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.

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.

DeOliveira, senior director, global regulatory operations, Cerevel (now part of AbbVie) highlights her experience in regulatory operations and how to address increased oversight from regulators.

An exploratory analysis from the TROPION-Lung01 Phase III trial found that tumors expressing TROP2 were associated with significantly improved responses to datopotamab deruxtecan compared to docetaxel in patients with non-small cell lung cancer.

In a fireside chat with ACT editor Andy Studna, Burks, vice president, site solutions highlights her career path and streamlining workflows between sites and sponsors.

Results from the Phase III MARIPOSA study found that the combination therapy showed an 8% improvement in overall survival in non-small cell lung cancer compared to osimertinib.

By embracing this leadership approach, clinical research stakeholders can prioritize more effective staff training and readiness.

Potential first-in-class B7-H3 directed antibody drug conjugate ifinatamab deruxtecan shows potential to improve outcomes for patients living with difficult-to-treat form of lung cancer.

Improving accessibility drives faster and more efficient patient enrollment and a more diverse trial population.

Across two clinical trials in the QWINT program, efsitora showed non-inferior A1C reduction compared to other frequently used daily insulins.

Study finds nearly 75% of patients with heterozygous familial hypercholesterolemia achieved a ≥50% drop in serum LDL-C concentration from baseline to about 12 months of therapy with a PCSK9 inhibitor.

Study findings suggest that most qualitative systemic reviews implement a generic approach as opposed to focusing on equity, diversity, and inclusion issues.

Latest version offers a streamlined site-centric experience to simplify relationships with study sponsors.

Lu AG09222 shows promise as first-in-class medication that prevents neurogenic inflammation, vasodilation, and parasympathetic lacrimation, which are considered to be surrogate markers of migraine attacks.

While measuring and managing site costs can be challenging, these codes can aid in accounting for labor expenses, budgeting for sponsors, and more.