Tufts CSDD is conducting new research on trends in study monitoring and data collection.

Mats Sundgren, PhD, senior industry science director, European Institute for Innovation through Health Data (i-HD), discusses how the integration of artificial intelligence, real-world data, and eSource can solve major challenges with patient recruitment and data management.

The REAL8 basket study showed Sogroya (somapacitan) was non-inferior to Norditropin (somatropin) in improving yearly growth rate.

Final overall survival results from the Phase III APHINITY trial show a 17% reduction in the risk of death at 10 years for patients with HER2-positive early-stage breast cancer treated with a Perjeta-based adjuvant regimen.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, discusses how clinical operations professionals should be focusing on flexibility, behavioral visibility, and communication in the current landscape of managing vaccine trials.

Overcoming hurdles with licensing complexities, post-production changes, and IRB submissions can help in reducing timelines and increasing collaboration.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, highlights how patients’ perspectives on vaccine trials may shift if a policy change was to take place.

In the first head-to-head comparison of leading incretin-based therapies, Eli Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide (Zepbound) delivered significantly greater and sustained weight loss than semaglutide (Wegovy) over 72 weeks in adults with obesity or overweight and comorbidities.

Updated GLISTEN trial results presented at EASL 2025 confirm that the IBAT inhibitor linerixibat significantly improved worst itch scores and itch-related sleep interference over 24 weeks in adults with primary biliary cholangitis.

In the POTOMAC study, one year of treatment with Imfinzi (durvalumab) plus standard-of-care BCG induction and maintenance therapy showed a meaningful improvement in disease-free survival.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, talks patient recruitment and retention in vaccine studies as well as how behavioral, analytical tools can help patient support.

In this video interview, Krinx Kong, chief commercial officer, Cognivia, discusses how trial design and timelines could be impacted by a potential mandate for placebo use across all vaccine trials.

The JADE study will be evaluating BI 1584862, an investigational oral compound that targets inflammation and preserves vascular function.

Updated results from the Phase III ELATIVE trial reveal Iqirvo (elafibranor) significantly reduced fatigue in patients with primary biliary cholangitis, with effects independent of pruritus and supported by proteomic data.

Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Topline results from the Phase III DESTINY-Breast11 trial show that Enhertu (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab, and pertuzumab significantly improves pathologic complete response rates compared to anthracycline-based standard-of-care regimens in the neoadjuvant treatment of high-risk, locally advanced HER2-positive early-stage breast cancer.

JNJ-1900 (NBTXR3), a novel, potentially first-in-class oncology therapy, demonstrated a median overall survival of 23 months from date of diagnosis as well as a favorable safety profile.

A Phase III randomized trial published in JAMA Network Open found no significant difference in symptom improvement between onabotulinumtoxinA injections and midurethral sling surgery in women with moderate to severe mixed urinary incontinence, with many ultimately needing both therapies to sustain relief.

Companies share their experience in future-proofing clinical data technology.

The single-inhaler demonstrated a meaningful improvement in lung function in the Phase III KALOS and LOGOS studies.

New long-term extension data from the Phase IIb/III QUASAR trial demonstrate that Tremfya (guselkumab) maintains durable clinical and endoscopic remission through 92 weeks in adults with moderately to severely active ulcerative colitis, with consistent efficacy across prior biologic and JAK inhibitor exposure.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, touches on how he would like to see greater industry collaboration in connecting cancer patients with RWD.

An article published by the Journal of the American Medical Association highlights recent updates made to the CONSORT checklist and how they ensure the accuracy of trial reports.