Evaluating the Current State of Randomized Platform Clinical Trials
Systematic review of 127 recent platform trials showed insufficient reporting of important trial information.
Top-Line Data of Phase II/III HEALEY ALS Platform Trial Shows Improvements in Function and Mortality
Despite improvements, results from the study of SLS-005 (IV trehalose), a low molecular weight disaccharide, did not meet statistical significance.
Utilizing Generative Artificial Intelligence to Increase the Understandability of Inpatient Discharge Summaries
Results of cross-sectional study of 50 discharge summaries suggest a large language model can be used to increase their understandability.
Phase III Trial Data Reinforce Potential of Imfinzi and Lynparza and Imfinzi Regimen for Endometrial Cancer
Analysis of trial results show Imfinzi and Lynparza displayed a strong clinical benefit and more than doubled median duration of response vs. chemotherapy.
FDA Votes in Favor of Potential Myeloma Therapy Following Positive Results of Phase III Clinical Trial
Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients based on results from the pivotal Phase III KarMMa-3 study.
Is Drug Development More Aligned With Burden of Disease in the United States or Globally?
Cross-sectional study of recent FDA drug approvals evaluated how closely they were aligned with US and global burden of disease.
Medical University of South Carolina and Flatiron Health Announce Collaboration
Collaboration brings Flatiron’s oncology-specific decision support platform to oncology care clinicians at MUSC Hollings Cancer Center.
PCM Trials Acquires EmVenio Research
Effective immediately, the acquisition strengthens both organizations’ abilities to recruit and retain diverse populations for clinical trials.
Q&A: Prioritizing Patient Diversity in Trial Design and Outreach
Tola Olorunnisola, senior vice president – general manager, clinical services and strategy, at Avantor, discusses the progress and challenges in incorporating more diversity-driven measures in drug development.
Results From Phase II Study of Islatravir and Lenacapavir Combination Show Viral Suppression in Patients With HIV
Investigational, once-weekly combination shows promise as long-acting oral treatment option for those virologically suppressed with HIV.
New Real-World Data Supports Use of Antiviral Therapy for Patients Hospitalized With COVID-19
Gilead’s Veklury (remdesivir), a nucleotide analog prodrug, was associated with lower risk of developing long-COVID.
Diversity in Clinical Trials: The Need to Take Action
Gadi Saarony, CEO of Advarra discusses the current state of diversity in clinical trials and how industry needs to be more proactive in addressing it.
Positive Phase I Study Results Show Promise for Potential Acute Pain Therapy, Mitigating Major Risks of Existing Opioids
Elysium Therapeutics’ proprietary O2P is a hydrocodone prodrug for the treatment of moderate-to-severe acute pain.
Analyzing Industry’s Current Perceptions of Parallel-Group Cluster-Randomized Trials
While little research on open-cohort designs currently exists, could this design be a solution to challenges currently seen in closed-cohort designs?
Phase I Trial for Potential Obesity Treatment Receives IRB Approval
DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR).
Creating a Framework for Increased Accessibility in Palliative Care Research
With inequalities in palliative care provisions, recent study seeks to create a more equitable, diverse, and inclusive framework based on Patient and Public Involvement.
The Current State of Diversity in Randomized Clinical Trials for Peripheral Artery Disease
With significant race and sex disparities in the area of peripheral artery disease, a study shows that clinical trials often lack representative patient populations.
Results of Phase II Clinical Trial Show Promise for Potential Obesity Treatment
VK2735 is a dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors.
FDA Approves Expanded Indication for HIV Therapy to Treat People with Suppressed Viral Loads, Pre-existing Resistance
Gilead’s Biktarvy is now the first and only INSTI-based single-tablet regimen that is FDA approved and DHHS guideline recommended for people who are virologically suppressed with M184V/I resistance.
FDA Reaches Agreement on Endpoints for Approval of Budiodarone for the Management of Atrial Fibrillation
Biopharma company XYRA and FDA have concluded a series of Phase II meetings on managing key studies for potential atrial fibrillation therapy, budiodarone.
Advarra CEO Discusses Implementing Technology in Diverse Clinical Trials
In an interview with ACT Editor Andy Studna, Gadi Saarony, CEO of Advarra talks about using technology to better diversify clinical trials and what to expect in the new year.
Therapeutic Vaccine for Chronic Hepatitis B Enters Clinical Trial
Phase Ia, open-label, escalating dose study to evaluate the safety and immunogenicity of therapeutic vaccine, TherVacB.
Advarra CEO Discusses Improving Diversity In Clinical Trials
In an interview with ACT Editor Andy Studna, Gadi Saarony, CEO, Advarra, offers his thoughts on the status of the pharmaceutical industry improving diversity in clinical trials.
ImmunityBio Announces Full Accrual of First Two Phases of Cancer Vaccine Trial
Enrollment and initial follow up has been completed for study set to test efficacy of cancer vaccine in individuals with Lynch syndrome.
NeuroSense Reports Additional Positive Results from Phase IIb ALS Clinical Trial
Clinical-stage biotech’s lead drug candidate, PrimeC for the treatment of ALS demonstrated a clinically meaningful effect on quality of life and on complication free-survival for patients.
First Subject Dosed in Phase I Clinical Trial of Investigational Protein Degrader for Neurodegenerative Disease
ARV-102 is a novel oral PROTAC protein degrader designed to cross the blood-brain barrier and target leucine-rich repeat kinase 2.
Worldwide Clinical Trials Expands Clinical Pharmacology Unit
Upgrades include end-of-life equipment replacements and relocation.
First Patient Randomized in Phase II Gene Therapy Trial for Congestive Heart Failure
Phase II GenePHIT trial is evaluating the safety and efficacy of a single intracoronary infusion of AB-1002.
SCOPE 2024: YPrime CEO, Jim Corrigan Speaks About the Company and Addressing Uncertainty in Clinical Trials
In an interview with ACT editor Andy Studna at SCOPE, Corrigan discusses what YPrime is doing to address challenges in clinical trials and results from the company's recently released eCOA report.
SCOPE 2024: Alex Deyle of Flatiron Health Discusses RWD in Clinical Trials
In an interview with ACT editor Andy Studna at SCOPE, Deyle, VP & GM, Clinical Research, Flatiron Health discusses real-world evidence in clinical trials.