A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials – Part 2

By Natalia Drosopoulou, Ph.D., Executive Director of Global Project Management, Neuroscience, Worldwide Clinical Trials,
biomarkers in brain diagnostics

  In part two of this blog series on selecting biomarkers for clinical research of the central nervous system, Talking Trials asked Worldwide’s Dr. Drosopoulou, author of the recent article, “A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials,” published in the Journal for Clinical Studies, to weigh in on the use of biomarkers for clinical research.

Read More

A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials – Part 1

By Natalia Drosopoulou, Ph.D., Executive Director of Global Project Management, Neuroscience, Worldwide Clinical Trials,
biomarkers in brain diagnostics

  For this two-part blog series, Talking Trials asked Worldwide’s Dr. Drosopoulou, author of the recent article, “A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials,” published in the Journal for Clinical Studies, to weigh in on the use of biomarkers for clinical research. Clinical trials using biomarkers in patient selection have higher overall success probabilities than clinical trials without biomarkers.1 That’s one of the many compelling results from a recent study of drug development success published in the journal Biostatistics. Wong and colleagues found clinical trials using biomarkers to stratify patients exhibit almost twice the overall probability of success compared to trials without biomarkers (10.3% vs. 5.5%).

Read More

How eCOA Simplifies Alzheimer’s Disease Research

Alzheimer’s disease research, electronic Clinical Outcomes Assessments

  Alzheimer’s disease research is taking advantage of new technology, including eCOA. To understand this trend, Talking Trials spoke with Will Tucker, Worldwide Clinical Trials’ Associate Director of Clinical Assessment Technologies (CAT). Will serves as a key leader in the CAT department, managing a highly experienced scale management, rater training, and reliability group that is seamlessly integrated with Worldwide’s Site Feasibility & Recruitment, Project Management, Clinical Operations, and Medical Monitoring groups. As the pharmaceutical industry moves away from paper administration of scales and toward electronic solutions, CAT now partners with industry leaders in electronic Clinical Outcomes Assessments (eCOA) and has expanded its offerings to include eCOA vendor oversight.

Read More

Metabolomics Provides Good Source of Small Molecule Biomarkers

biomarker methods

By Michael Sullivan, Senior Research Fellow, Worldwide Clinical Trials   Small molecule biomarkers provide insight into metabolic pathways related to therapeutic treatment and can help explain the mechanism of action during drug development for an array of therapeutic areas.

Read More