• Pragmatic Trial Suggests It May Take A Village To Tap Full Potential Of Genomics

    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.

    Apr 25, 2022

  • Continuous Bioprocessing of Biologics: The Future is Bright

    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.

    Apr 22, 2022

  • CLIA-Certified Alzheimer’s Blood Test Gets High Marks In Global Study

    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.

    Apr 19, 2022

  • ‘Professional Patient’ Detection Now A Clinical Study Essential

    Clinical Research News | After more than a decade in the business of detecting “professional patients,” Verified Clinical Trials is a familiar name to stakeholders across the research enterprise—including the nefarious players who ride-share from city to city in search of unprotected sites where they can enroll in studies purely for the financial gain. It’s an underappreciated underground economy that is costing sponsor companies time and money and, in some cases, completely shutting down studies, according to Mitchell Efros, M.D. FACS, CEO of Verified Clinical Trials.

    Apr 13, 2022

  • Seqster Launches Real World Data Tools on Salesforce AppExchange

    Clinical Research News | Seqster PDM has launched SeqsterOS, the operating system for patient registries and clinical studies on Salesforce AppExchange integrated directly with Salesforce Health Cloud. SeqsterOS seeks to empower life science enterprises to seamlessly integrate patient-consented Real World Data, including electronic health records (EHR), genomics, and device data, with a patient engagement layer for their clinical studies.

    Apr 12, 2022

  • EMA Endorses Biomarkers For Type 1 Diabetes Prevention Trials

    Clinical Research News | Following many years of collaborative patient-level data sharing across stakeholder groups, the European Medicines Agency (EMA) recently endorsed pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) trials focused on delaying or preventing the disease. The Qualification Opinion appears on both the EMA website and that of the Critical Path Institute’s (C-Path) Type 1 Diabetes Consortium (T1DC).

    Apr 8, 2022

  • Building Clinical Trial Infrastructure for Greater Diversity

    Clinical Research News | The life sciences industry has faced recent criticism for its continued challenge to boost diversity in clinical trials. Reports suggest that the US Food and Drug Administration (FDA) is currently at work on guidance that will define how the agency would interpret “adequate representation” of ethnic, racial and age diversity to increase representation of traditionally underrepresented populations in drug development. This will ensure organizations are broadening eligibility criteria through inclusive trial practices and trial design.

    Apr 8, 2022