News

The Phase II study, PROGRESS-AD, will evaluate the safety and efficacy of human monoclonal antibody AL101/GSK4527226 over 76 weeks.

In Phase III MINT trial, Uplizna (inebilizumab) demonstrated significant short-term efficacy and a manageable safety profile in adult patients with generalized myasthenia gravis, offering a promising B-cell–targeting treatment option pending long-term data.

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discusses how artificial intelligence can aid in bringing therapies to rare disease patients faster.

In addition to meeting the primary endpoint of superior A1C reduction, the once-daily oral pill reduced weight by an average of 16 lbs.

Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.

In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.

With close collaboration between sponsors, CROs, and regulators, this emerging technology has the potential to greatly improve the lives of patients.

Adding Farxiga (dapagliflozin) to standard care significantly reduced the risk of death or worsening heart failure in older patients with severe aortic stenosis following transcatheter aortic-valve implantation, with consistent benefits across patient subgroups and a favorable safety profile.

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, highlights the Rally for Rare event and how it succeeded in providing the community a space for collaboration and innovation.

Tolebrutinib, a brain-penetrant BTK inhibitor, may fill a significant unmet need by delaying disability progression in patients with non-relapsing secondary progressive multiple sclerosis.

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, talks collaboration and maximizing resources among the various stakeholders in rare disease research.

In this video interview, Derek Ansel, vice president, therapeutic strategy lead, rare disease, Worldwide Clinical Trials, discusses the most prominent challenges he is seeing in the space right now including competing research priorities and finding endpoints.

An increase in protocol complexity is paving the way for machine learning models to optimize trial design.

In the Phase III EXPECTS trial, patients experiencing mostly mild posterior circulation ischemic stroke who were ineligible for thrombectomy showed significantly better functional recovery at 90 days when treated with alteplase between 4.5 and 24 hours after stroke onset, without an increased risk of symptomatic intracranial hemorrhage.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, highlights the need for maintaining data privacy in a highly regulated clinical research industry.

Study uncovers insights on the impact on safety, patient enrollment/retention, and compliance.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, discusses how an emphasis on patient centricity can encourage more sustainable trial designs.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, talks the current landscape of sustainability in clinical trials and how stakeholders are beginning to pay more attention to carbon footprint amid increasing protocol complexity.

Why investing in truly effective training from the outset can pay off exponentially for clinical teams—and serve as a strategic advantage.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, highlights where regulatory agencies currently stand on sustainability in clinical trials and how pharma companies are looking to reduce their carbon footprint.

In the Phase III MUSETTE study, a higher dose of intravenous Ocrevus (ocrelizumab) did not provide additional benefit in slowing disability progression compared to the currently approved 600mg dose.

Long-term extension data show Tremfya (guselkumab) significantly reduced symptoms and inhibited structural joint damage progression in patients with active psoriatic arthritis.

In this video interview, Thierry Escudier, portfolio lead, Pistoia Alliance, discusses the alliance’s latest step in evaluating the sustainability of digital versus traditional clinical trial approaches.

In the SmartfIRE study, the Thermocool Smarttouch SF catheter showed an 86.9% effectiveness rate among patients treated with high adherence to recommended ablation parameters.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), discusses numerous themes that clin ops can focus on to keep its trials running efficiently and effectively.

Research collaboration between Tufts and the Society for Clinical Research Sites explores the prevalence of this belief in healthcare.

Phase III SOUL trial shows daily oral semaglutide lowers the risk of major adverse cardiovascular events in patients with type 2 diabetes and atherosclerotic cardiovascular disease or chronic kidney disease, with benefits consistent with injectable semaglutide and other GLP-1 receptor agonists.

In this video interview, Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), highlights how research communities have self-organized in light of recent changes.