News

Spearheaded by disease foundations, the creation of clinical registries is streamlining data collection and driving informed decisions.

Trial to analyze novel therapy MK-1084 plus Keytruda (pembrolizumab) in certain patients with metastatic non-small cell lung cancer whose tumors harbor KRAS G12C mutations and express PD-L1.

Multiple sites will be added to the trial through collaboration with network of community-based oncology practices.

A study conducted by the Tufts CSDD in collaboration with CluePoints and PwC revealed that slightly more than half of sponsors and contract research organizations have adopted risk-based quality management approaches.

In the Phase III BE HEARD I and BE HEARD II trials, a greater proportion of patients with moderate-to-severe hidradenitis suppurativa who were administered Bimzelx achieved the primary endpoint of clinically meaningful improvements in HiSCR50.

In part 2 of this video interview with ACT editor Andy Studna, Tirisham Gyang, MD, assistant professor of neurology at The Ohio State University discusses how industry can effectively enroll patients from underrepresented populations into their trials.

Open label, dose-escalation trial is testing the efficacy of LyGenesis’ first-in-class allogenic regenerative cell therapy.

Raludotatug deruxtecan is a potential first-in-class CDH6-directed antibody drug conjugate that has shown promise in patients with CDH6-expressing serous-type ovarian cancer and renal cell carcinoma.

In part 1 of this video interview with ACT editor Andy Studna, Tirisham Gyang, MD, assistant professor of neurology at The Ohio State University discusses how new research is changing the way industry recognizes multiple sclerosis in non-white populations.

The investigational TROP2-directed antibody drug conjugate improved progression-free survival in patients with unresectable or metastatic HR-positive, HER2-negative breast cancer.

While there is still potential left to be unlocked, current uses of artificial intelligence in clinical research include drug discovery, determining patient disposition, and dosing.

An increasing number of patients report looking for more simplicity and less burden related to a clinical trial, and a "bring your own device" option is one of the ways to meet this need

Phase III GATHER2 trial data show Izervay reduced the rate of geographic atrophy lesion growth across every month and every-other-month dosing through two years of treatment.

Krazati (adagrasib) was previously granted accelerated approval by the FDA to treat patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer who were previously administered at least one systemic therapy.

Over a 3.5-year period, members of EU-PEARL developed revamped templates for integrated research platforms to address their evolving complexity.

In the fourth and final part of this video interview, Greg Sturmer, co-founder and CEO of Elysium Therapeutics discusses the key features of O2P as well as plans for further development of the hydrocodone prodrug.

As clinical trials continue to advance and evolve to include real-world data, their success is becoming ever more dependent on the quality of data.

LPCN 1148 is an oral treatment that has shown promise preventing recurrence of overt hepatic encephalopathy and treating sarcopenia.

In part 3 of this video interview, Greg Sturmer, co-founder and CEO of Elysium Therapeutics discusses the development journey of his company's hydrocodone prodrug, O2P.

Systematic review of over 800 retracted articles suggest that better identification of postretraction citations should be implemented.

Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.

In part 2 of this video interview, Greg Sturmer, co-founder and CEO of Elysium Therapeutics discusses what industry should be keeping top of mind when it comes to designing and executing pain clinical studies.

mRNA-1283 was found to elicit a higher immune response against SARS-CoV-2 than Moderna's licensed COVID-19 vaccine, mRNA-1273.

In part 1 of this video interview, Greg Sturmer, co-founder and CEO of Elysium Therapeutics discusses the current state of opioid usage including how pain treatment is often mismanaged and how the industry can adopt greater safety standards in developing pain therapies.

Combination demonstrated a favorable trend toward overall survival in non-small cell lung cancer patients.

Because of drastic changes in the clinical trial space, there is a need for advancing and streamlining design through risk-based methodologies and innovations.

Odronextamab is being evaluated for the treatment of relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma following two or more prior lines of systemic therapy.

Systematic review of 127 recent platform trials showed insufficient reporting of important trial information.