• In War-Torn Ukraine, Clinical Trials Trudge Along

    May 17 | Clinical Research News | The clinical research situation in Ukraine has changed from “peaceful, predictable, and promising” a year ago to “complex, complicated, and difficult” since the Feb. 24 Russian invasion, according to Serhiy Mykhaylov, Merck’s clinical research director in the country speaking during a recent DIA webinar on the ethical dilemmas the war has created for those supporting study participants in the region. As of six months ago, Ukraine had 500 active ongoing studies. More
  • Sequencing-Based Initiative Now Exploring How Best To Return The Findings

    May 11 | Clinical Research News | A pioneering program of Geisinger Health System has returned clinically actionable results from exome sequencing to a record-breaking 3,400 individuals at increased risk for potentially life-threatening conditions such as hereditary breast and colon cancers, familial hypercholesterolemia (FH), and heart disease. The MyCode Community Health Initiative, enabled by a 2014 agreement with Regeneron Pharmaceuticals, draws from participants in a sizable DNA biobank who agree to the sequencing and results reporting. More
  • Liquid Biopsy Test Shows Promise For Pediatric Glioma

    May 10 | Clinical Research News | Evidence is emerging that cerebrospinal fluid (CSF) testing might be useful in clinical settings for monitoring tumor growth and treatment response in pediatric patients with diffuse midline glioma (DMG), a lethal high-grade brain tumor that is inoperable and unlikely to be cured. Only about 500 new cases get diagnosed in the U.S. in any given year, but over two-thirds of them carry the exact same mutation (H3 K27M) allowing development of an assay that analyzes cell-free tumor DNA samples using digital droplet polymerase chain reaction (ddPCR). More
  • Future-Proofing Trials with HCP Selection to Improve Source Data and Quality Management for Sponsors and CROs

    May 06 | Clinical Research News | Accurate information is the foundation of any quality research study, particularly when the study is decentralized or takes a hybrid approach. For decentralized clinical trials (DCTs), the appropriate selection of healthcare practitioners is all the more important to ensure patient care and data integrity. More
  • The Scope of Things: Ken Getz’s Data-Driven Approach to Patient Engagement

    May 03 | Clinical Research News | Ken Getz and host Deborah Borfitz explore patient engagement for the newest episode of the Scope of Things podcast. Getz, Executive Director & Research Professor at the Tufts Center for the Study of Drug Development (CSDD), shares what his research has revealed about how patient engagement efforts are progressing, where we’re stuck in a rut, and a crucial misalignment in the industry’s view of patient engagement and what clinical research participants actually want. More
  • Follow the Money: Digital Twins in Clinical Research, Virtual Care and Digital Medicine, More

    Apr 29 | Clinical Research News | Funding for digital twin use in clinical trials, immune-oncology cancer therapeutics, and virtual care and digital medicine, and more. More
  • AI and ML in Clinical Trials; Risk Management Software Update; Synthetic Control Arms; Decentralized Clinical Trials; More

    Apr 28 | Clinical Research News | AI and ML in clinical trials, patent for minimum residual tumor detection, T-cell receptor engineering for cancer treatment, award given for COVID-19 clinical trial activities, synthetic control arms and decentralized trials, and more. More
  • Pragmatic Trial Suggests It May Take A Village To Tap Full Potential Of Genomics

    Apr 25 | Clinical Research News | In a pragmatic clinical trial at a pair of health systems in New York City, researchers at the Mount Sinai Health System have determined that the full potential of genomics to improve clinical patient management may well depend on engaging community-based racial and ethnic minority groups in the effort. The National Institutes of Health is now funding a large, comprehensive nationwide study (GUARDD-US) through the Implementing Genomics in Practice (IGNITE) network aimed both at changing health behaviors and making pharmacogenomics-based treatment recommendations. More
  • Continuous Bioprocessing of Biologics: The Future is Bright

    Apr 22 | Clinical Research News | While most medicines are derived from chemical compound, biologics are now the fastest-growing drug class. To deliver these complex drugs to patients as quickly as possible, the biopharmaceutical industry is shifting away from traditional batch processing to continuous bioprocessing. More
  • CLIA-Certified Alzheimer’s Blood Test Gets High Marks In Global Study

    Apr 19 | Clinical Research News | A blood test to help clinicians diagnose Alzheimer’s disease is “on the road” to effectively replacing cerebrospinal fluid (CSF) testing and PET scans for detecting Alzheimer’s pathology, according to Randall J. Bateman, M.D., a professor of neurology at Washington University School of Medicine and co-developer of the plasma protein assay. A commercial version of the test, PrecivityAD, is already being used extensively in clinical trials as well to evaluate patients in real-world settings. More
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