Andy Studna, Senior Editor

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.

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.

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

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.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, discusses how real-world data and real-world evidence have helped expedite cancer research.

Approval is based on results from the Phase III ASCEND trial, in which patients using the powder achieved freedom from pain by 2 hours post-treatment in 34.2% of migraine attacks.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, highlights cost and treatment sequencing as some of oncology’s largest hurdles.

Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, shares his key takeaways from a recent study he led on data reporting in oncology and highlights how stakeholders should be closely analyzing the accuracy of data they work with.

In the Phase Ib Beamion LUNG-1 clinical trial, zongertinib, an investigational irreversible tyrosine kinase inhibitor, demonstrated a median duration of response of 14.1 months.

In this video interview, C.K. Wang, MD, chief medical officer, COTA, discusses a recent study he led on the validity of using real-world data for reporting mortality.

In the pivotal CREST clinical trial, sasanlimab in combination with Bacillus Calmette-Guérin met the primary endpoint of event-free survival.

Xofluza (baloxavir marboxil) met its primary endpoint in the CENTERSTONE trial, reducing the odds of untreated household members contracting influenza virus by 32%.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, shares his key takeaways from Cencora’s recent TMF Leadership Summit and touches on the importance of oversight when working with outside stakeholders.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses how risk-based approaches must be prioritized amidst the increased demand for quality and compliance.

Cobenfy (xanomeline and trospium chloride) as an adjunctive treatment to atypical antipsychotics demonstrated a 2.0-point reduction in PANSS total score in the ARISE study, failing to meet statistical significance.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, highlights recent ICH guidelines and how risk should be an area of focus as trial designs continue to get more complex.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, talks AI and how change is needed for the clinical trials industry to fully understand its potential with automation.

In this video interview, Rob Jones, product manager, TMF practice area, Pharmalex, discusses challenges the TMF space is currently facing and how it can utilize collaboration in making advancements.

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

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.

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.

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.

Results from a subgroup of the ICONIC-LEAD study show 75% of adolescents with plaque psoriasis achieved completely clear skin.

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.

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