• The NIH’s Strategic Plan to Cure Hepatitis B, Merck’s New Clinical Research Data Platform, More

    Clinical Research News | An ultra-sensitive assay accurately measures antibodies against SARS-CoV-2; a single-vendor gene-to-mRNA service delivers custom mRNA within six to eight weeks; Mayo Clinic manufactures biotherapeutics for rare and complex conditions; and more.

    Aug 31, 2022

  • Follow the Money: Cross-Disciplinary Viral Emergence Research Institute, New Anti-Aging Research Initiative, More

    Clinical Research News | Funding for Johns Hopkins international tuberculosis research project, new yellow fever, rabies, and chronic hepatitis B vaccines, multiple sclerosis research grants, and more.

    Aug 30, 2022

  • When Will We Solve the Patient Engagement Dilemma?

    Clinical Research News | Adopting countless tools to engage patients and capture information in trials limits the opportunity to share common learnings, establish standard procedures, or gain economies of scale through replication across studies. With standardized processes and workflows, sponsors can reduce implementation complexity and create a repeatable model across most studies with minor changes.

    Aug 26, 2022

  • ‘Laboratory For Motion’ Uses AI To Turn Movements Into Clinical Endpoints

    Clinical Research News | Movement can now be used as a functional biomarker and endpoint for all sorts of treatments—including orthopedic surgery for bad knees and hips, spinal cord stimulation for debilitating back pain, weight-loss programs for obesity, and even laser surgery for glaucoma.

    Aug 25, 2022

  • AI Could Help Spot Difficult-To-Detect Pancreatic Cancer Sooner

    Clinical Research News | Radiomics-based machine learning models have been shown to do an impressive job of detecting pancreatic cancer on pre-diagnostic CT scans several months before symptoms appear, suggesting that one day the disease will more often be diagnosed at a stage where a surgical cure may be possible.

    Aug 23, 2022

  • Survey Suggests Alzheimer’s Research Is Missing the Boat

    Clinical Research News | A research team is advocating for a more data-driven approach to Alzheimer’s research where sets of biological pathways get grouped with mechanisms the body itself uses to ward off the disease.

    Aug 18, 2022

  • Long COVID and Chronic Fatigue Syndrome Have A Lot In Common

    Clinical Research News | Evidence is emerging that long COVID (formally “post-acute sequelae SARS-CoV-2 infection,” or PASC) bears a striking, molecular-level resemblance to the disabling and complex illness now known as myalgic encephalomyelitis/chronic fatigue syndrome.

    Aug 16, 2022

  • A Blended Solution–How Midsize Pharmaceutical and Biotech Companies Can Optimize the Delivery of Their Clinical Trials

    Clinical Research News | Large biopharma companies use two outsourcing models to deliver their clinical trial portfolios: CRO and FSP. But what about mid-sized companies? As they experience significant growth in development, have their operating models grown with them?

    Aug 12, 2022

  • Classification System For Colorectal Cancer Needs An Update

    Clinical Research News | A multi-national team of clinicians and scientists has determined that the consensus molecular subtype (CMS) classification of colorectal cancer needs updating to better reflect the molecular underpinnings of the disease.

    Aug 11, 2022

  • GA4GH Phenopackets Standard Published By ISO

    Clinical Research News | The International Organization for Standardization (ISO) has published Phenopackets, a standard initially developed by the Global Alliance for Genomics and Health and championed at ISO under the Canadian Mirror Committee to ISO/TC215/SC1 Genomics informatics, and supported by the Standards Council of Canada.

    Aug 10, 2022

  • Online ‘Biclustering’ Tool Stratifies Patients To The Molecular Level

    Clinical Research News | Researchers in Germany have developed a web-based tool, powered by machine learning, which extracts disease subtypes from large pools of patient data. The goal is more precise and robust predictions about molecular signatures that can serve as a starting point for investigating disease heterogeneity.

    Aug 9, 2022

  • Walgreens’ Decentralized Clinical Trial Future

    Clinical Research News | In June, Walgreens launched its clinical trial business in an effort to combine the company’s vast foundation of patient insights, partner-enabled health and technology capabilities, and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.

    Aug 4, 2022

  • Finding the Silver Lining: Data and Knowledge Sharing Through Research Data Networks

    Clinical Research News | Research communities face tremendous challenges in creating and acquiring FAIR data. In the latest Scope of Things podcast episode, Dipak Kalra, president of i~HD, talks about research data networks, navigating the pandemic, and new data regulations from the European Commission.

    Aug 2, 2022

  • Leveraging Non-Wrist Wearables for Healthcare and Clinical Trials

    Clinical Research News | Wearables enable us to measure and derive any number of digital clinical endpoints, but their value—and challenge—lies in having those endpoints validated and broadly accepted. An open-source approach to algorithm development is crucial, especially involving non-wrist wearable use cases.

    Jul 29, 2022

  • PTSD Adaptive Platform Trial, Long COVID Phenomics Research, More

    Clinical Research News | The American Heart Association hosts a six-month challenge testing heart failure and the social determinants of health; research accelerates for an NGS-based diagnostic test to identify cancer; a multi-year project enlists 10,000 people 95 and older to explore the biological and genetic underpinnings of exceptional longevity; and more.

    Jul 28, 2022

  • Follow the Money: Nutrient Control for Cancer Inhibition, Patient Engagement Research Initiative, More

    Clinical Research News | Funding for centralized patient data network research, a new landmark clinical trial for neurologically impaired children, ALS vaccine development, and more.

    Jul 27, 2022

  • Cancer Centers Measure COVID-19 Impact on Clinical Trials

    Clinical Research News | A clinical team at Dana Farber Cancer Institute and Mount Sinai explored oncology clinical trial disruption during the COVID-19 pandemic. They found that substantial disruptions early in the pandemic gradually recovered, but some lasting changes remain.

    Jul 21, 2022

  • Case Series Paves Way For Clinical Trials With Phage Therapy

    Clinical Research News | In collaboration with physicians from around the world, researchers at the University of Pittsburgh and the University of California San Diego School of Medicine recently reported on a series of 20 consecutive cases where an intractable, non-tuberculous Mycobacterium infection was treated with phage therapy over an average course of six months. More than half of those patients saw a favorable clinical or microbiological outcome.

    Jul 19, 2022

  • Milestones Easier To Meet With Integrated Clinical Trials Management System

    Clinical Research News | Until recently, clinical study teams at the Medical University of South Carolina had no system for registering participants, keeping track of upcoming study visits, or what to invoice when on industry-sponsored projects. All that is changing with implementation of a clinical trials management system, fully integrated with the university’s Research Integrated Network of Systems, in mandatory use since March 2022 for all new trials undertaken across campus.

    Jul 14, 2022

  • Tufts Study Provides ‘First Hard Metrics’ Around Decentralized Clinical Trials

    Clinical Research News | Decentralized clinical trials can deliver a higher “expected net present value” that equates to a roughly $10 million return on a $2 million investment for phase 2 trials and $39 million return on a $3 million investment for phase 3 studies. The economic savings come from reduced cycle times, improved patient screening and enrollment, and fewer protocol amendments over the life of a trial.

    Jul 13, 2022