• 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

  • Worldwide Clinical Trial, Invitae Announce RWD Platform Partnership

    Clinical Research News | Worldwide Clinical Trials and Invitae have announced a strategic partnership. Worldwide will be the first CRO to use Invitae’s Explorer tool, part of its real-world data platform that enables access to aggregated genetic testing results.

    Jul 12, 2022

  • How the World’s First Clinical Trial Market Network Saves Stakeholders Time and Money

    Clinical Research News | ClinEco–a clinical trial ecosystem and market network designed to streamline the process of identifying and selecting clinical trial partners–is the first of its kind. It reduces the cost and speed of studies by catering to the specific needs of individual sponsors and vendors.

    Jul 12, 2022

  • Drug Repurposing Strategy Without An ‘Answer Book’

    Clinical Research News | Scientists working in the information biology lab at Hokkaido University in Japan have come up with a drug repurposing strategy combining machine learning, unsupervised clustering of gene expression, and two-stage prediction.

    Jul 7, 2022

  • Clinical Trial Repurposing A Heart Drug For Non-Alzheimer’s Dementia

    Clinical Research News | A combined analysis of autopsy cohorts in 13 studies across three continents highlights growing appreciation of the heterogeneity of dementia and the critical need for clinical trials to tease out the underlying molecular mechanisms. The “inconvenient truth” is that the brain is the most complicated organ in the body and entitled to more than one aging-related disease.

    Jul 5, 2022

  • Parexel’s New Community Alliance Network, Illuminating Gut Microbiome Oncology Studies, More

    Clinical Research News | Artificial intelligence capabilities design potentially more precise and efficient clinical trials for Bristol Myers Squibb; a natural language generation platform accelerates clinical study submission processes; The University of Chicago Medicine helms a nationwide cancer study with 50,000 participants; a one-of-a-kind online tool for sharing, collecting, and analyzing data specifically about Down syndrome; and more.

    Jun 30, 2022

  • Follow the Money: Immune-Mediated Disease Therapy, Neurological Clinical Trials, More

    Clinical Research News | Funding for sepsis precision therapy, fully robotic biological data and research factory, antibody-drug conjugate therapeutics, and more.

    Jun 29, 2022

  • Clinical Trials To Benefit From New Staging System For Huntington’s Disease

    Clinical Research News | An international consortium of scientists has come up with a staging system for Huntington’s disease that tracks with its underlying biological, clinical, and functional characteristics in patients, as seen in those participating in four large prospective cohort studies.

    Jun 28, 2022

  • How AI and Computer Vision Can Solve Challenges in IBD Drug Development

    Clinical Research News | Advances in artificial intelligence-driven algorithms and computer vision can address bottlenecks that sponsors and physician investigators face in developing therapeutic options and matching inflammatory bowel disease (IBD) patients with a clinical trial.

    Jun 24, 2022

  • uMotif, ClinOne Partner for Integrated eCOA, eConsent

    Clinical Research News | uMotif and ClinOne have announced a partnership to provide integrated electronic clinical outcomes assessments (eCOA) and electronic informed consent (eConsent) technology. While currently the two solutions remain distinct, the companies presented the news as the first step on an ongoing partnership.

    Jun 22, 2022

  • Beyond FAIR: Building Platforms for Cultural Changes of Data Sharing

    Clinical Research News | At the Bio-IT World Conference & Expo last month, Alex Sherman, Director of the Center for Innovation and Bioinformatics, Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, explored what clinical research can look like practically beyond just checking boxes for findable, accessible, interoperable, and reusable.

    Jun 21, 2022

  • Moving Data for Clinical Trials: Standards, Systems to Link EHRs with EDC

    Clinical Research News | “Thirty to 40% of clinical trial costs are associated with actually just the manual retyping of [EHR] data [into the clinical trial system], and it leads to reporting delays and a number of other inefficiencies,” Adam Asare, chief data officer at the Quantum Leap Healthcare Collaborative/UCSF, told the Bio-IT World Conference & Expo audience last month. Asare shared a solution to that problem: a collaboration with OpenClinica that won the team a Bio-IT World Innovative Practices Award.

    Jun 16, 2022

  • PCORI Board Approves Strategic Plan, Funding for Maternal Health, Telehealth

    Clinical Research News | The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors has approved the development of new research funding opportunities, providing up to $63 million for studies on reducing maternal health inequities and up to $50 million for research on using telehealth to improve management of multiple chronic conditions.

    Jun 14, 2022

  • A 20-Year Perspective On Breast Cancer Clinical Trials

    Clinical Research News | Wider availability and uptake of mammography screening globally among women under age 60 closely align with a threefold increase in their participation in breast cancer clinical trials over the past two decades. The numbers jumped most dramatically, from 39% to 87%, between the 2005-2009 and 2010-2014 time periods. Those demographics should be prompting sponsor companies to take a fresh look at how they are designing studies in terms of who should and could be included. More can be done to improve clinical trial diversity while being mindful of the duty to protect subjects from harm.

    Jun 14, 2022

  • Side Effects Of Cancer Treatment Could Be Tempered By Intermittent Dosing

    Clinical Research News | The frequency, degree, and speed of onset of immune-related adverse events from the experimental cancer drug AMG319, an inhibitor of phosphoinositide 3-kinase δ (PI3Kδ), came as an unwelcome surprise in a recent clinical trial involving patients in the UK with head and neck cancer. But the study also served to highlight how “absolutely critical” understanding of the immune system is to the development of rational immunotherapy.

    Jun 9, 2022

  • Genetic Control Of Autoimmune Disease Mapped To Cellular Level

    Clinical Research News | The pioneering OneK1K study in Australia has identified an immune “fingerprint” of seven autoimmune disorders using single-cell RNA sequencing (scRNA-seq). The general framework, which combines the scRNA-seq data with genotype data to classify individual cells, can be applied to many different diseases.

    Jun 8, 2022