• New Test Looks at Unique Response of MS Patients to Epstein-Barr Virus

    Clinical Research News | Significant evidence now exists implicating the Epstein-Barr virus (EBV) as a causal factor in the development of multiple sclerosis (MS), making treatment of the virus a priority. To that end, research scientists at Trinity College Dublin have developed a blood test to measure the immune response to EBV that could be used as an outcome measure in future clinical trials in people with established MS.

    May 1, 2024

  • Bayesian Statistics: An Important Yet Underutilized Paradigm in Rare Disease and Small Population Drug Development

    Clinical Research News | Advances in medical understanding and treatment approaches are driving a revolution in the rare disease space. Approaches such as gene therapies and biologics are offering previously unimagined opportunities to tackle unmet need, changing, and even saving, lives.

    Apr 26, 2024

  • PathAI Enters Partnership With Google Cloud, Cardiometabolic Clinical Trials Platform, DNA/RNA Extraction Kits, More

    Clinical Research News | PathAI announced a strategic partnership with Google Cloud at Bio-IT World Conference & Expo to help biopharma companies and anatomic pathology labs accelerate the adoption of AI and digital pathology; Clinical ink has launched GlucoseReady, a fully integrated GCP compliant digital platform designed for the new era of cardiometabolic clinical trials; New England Biolabs has released its Monarch Mag Viral DNA/RNA Extraction Kit, which enhances recovery of low amounts of viral nucleic acid to enable highly sensitive detection; more.

    Apr 25, 2024

  • Follow the Money: Obesity Medicine Company Metsera Launched, Tumor-Infiltrating Lymphocyte Program, Novel Oncology Biologics, More

    Clinical Research News | Metsera has launched and will rapidly advance a broad portfolio of oral and injectable incretin, nonincretin, and combination therapies designed to meet the future needs of a rapidly evolving weight loss treatment landscape; Obsidian Therapeutics plans to advance its lead engineered tumor-infiltrating lymphocyte program, OBX-115, in its ongoing trials for patients with melanoma and non-small cell lung cancer; TORL BioTherapeutics has publicly launched and plans to advance its pipeline of antibody-drug conjugates and monoclonal antibodies; more.

    Apr 24, 2024

  • We Need a People-First Approach to Clinical Trial Technology

    Clinical Research News | The proliferation of mobile technology—including multiple generations of progressively smarter phones, tablets, watches, and other devices—has set the stage for similar types of eClinical innovation. However, the two types of technologies have not progressed at the same pace. This is unfortunate for all clinical trial stakeholders and, most notably, patients.

    Apr 19, 2024

  • EEG Monitoring Concerningly Underutilized In Clinical Trials

    Clinical Research News | Study sponsors making choices about if, when, and how to include brain monitoring in their clinical studies do not often ground those choices in science or optimize for subject safety and trial de-risking.The key problem is a lack of electroencephalogram (EEG) expertise with no guidance from the Food and Drug Administration (FDA) to mitigate the situation.

    Apr 16, 2024

  • Bridging Beyond Infectious Diseases: A Shift in Focus for African Clinical Sites

    Clinical Research News | Africa faces a dual healthcare challenge with the persisting burden of infectious diseases and the escalating prevalence of non-communicable diseases (NCDs). This shifting paradigm underscores the urgent need for African research sites to broaden their focus beyond infectious diseases and engage more robustly in NCD clinical research, with sponsors playing a pivotal role in actively ensuring clinical site participation.

    Apr 12, 2024

  • Citizen-Driven Research Aids Development Of Digital Biomarkers For ALS

    Clinical Research News | When it comes to research on amyotrophic lateral sclerosis (ALS), every stakeholder—most especially patients—knows time is of the essence. From diagnosis to death, life expectancy from the debilitating neuromuscular disease can be two years or less.

    Apr 10, 2024

  • Trial Begins For ‘Probabilistic Approach’ To Diagnosing Ovarian Cancer

    Clinical Research News | Scientists in the Georgia Tech Integrated Cancer Research Center (ICRC) are proposing a new, more realistic approach to diagnosing cancer that provides a probabilistic statement about the likelihood of developing it, much like how cholesterol tests are used to assess heart disease risk. Probabilities are based on an individual’s metabolic profile and the first population group to be targeted are women at high risk for ovarian cancer.

    Apr 9, 2024

  • Biology-Based Diagnostic Criteria For Parkinson’s Disease Research

    Clinical Research News | Scientists from a trio of countries are calling for a new, more comprehensive way of classifying Parkinson’s disease for diagnostic research purposes that considers an individual’s biology. The disorder might thereby be detected before patients have any symptoms, as is now the case for cancer and diabetes.

    Apr 4, 2024

  • Proteomics Approach Working Its Way To The Clinic For Stubborn Cancers

    Clinical Research News | For roughly half of patients with recurrence of often-deadly glioblastoma multiforme (GBM), their tumors are characterized by cells that look a lot like healthy neurons. The mimicry trick was discovered by proteomics, which has opened a view to tumor alterations unavailable through genetics alone.

    Apr 2, 2024

  • ‘Fragmentomics’ Approach Catches Cancers Earlier In The Blood

    Clinical Research News | A machine learning method dubbed A-PLUS (Alu Profile Learning Using Sequencing) recently demonstrated its ability to pick up cancers earlier and with smaller blood draws than is required for whole genome sequencing. This makes possible a future where people might get annual blood draws to check for cancer based on the “fragmentation pattern” of cell-free DNA (cfDNA) circulating in their blood.

    Mar 28, 2024

  • SEQSTER Selected By MSAA, Owkin Expands Collaboration With Sanofi, Thermo Fisher Scientific Launches New Clinical Registry, More

    Clinical Research News | SEQSTER has been selected by the Multiple Sclerosis Association of America (MSAA) for its patient-centricity, 1-Click Records, and cutting-edge longitudinal health record; Owkin adds immunology to Sanofi collaboration; Thermo Fisher Scientific launches a new CorEvitas syndicated clinical registry in generalized pustular psoriasis; and more.

    Mar 27, 2024

  • Follow the Money: Cystic Fibrosis Treatment, Advancing CAR-T Candidate, Modular T Cell Engagers, More

    Clinical Research News | Sionna Therapeutics plan to develop a first-in-class small molecules designed to fully restore the function of the cystic fibrosis transmembrane conductance regulator (CFTR) protein by stabilizing the first nucleotide-binding domain (NBD1); Capstan Therapeutics is advancing CPTX2309, the company’s lead in vivo chimeric antigen receptor T cell (CAR-T) candidate, to early clinical proof-of-concept in autoimmune disorders; Clasp Therapeutics is developing modular T cell engagers tailored to each patient’s immune system that are directed to common oncogenic driver mutations; and more.

    Mar 26, 2024

  • Electronic White Blood Cell Tracker Developed For Near-Patient Testing

    Clinical Research News | A revolution is underway in the diagnostics world that is reminiscent of what transpired in the computing field before the advent of PCs and smartphones. The unimagined possibilities of today will come from democratizing technology so that instead of sending patients to the lab, the lab will get sent to patients—and, ultimately, be available to them in the form of at-home testing kits.

    Mar 21, 2024

  • Latest Oral Insulin Drug Making Its Way To Clinical Trials

    Clinical Research News | More than a century has passed since the discovery of insulin, the world's first life-saving treatment for diabetes, and it is still being delivered via injection despite several brushes with success in developing an oral version of the drug. Hope is again on the horizon with the emergence of an oral nanotherapeutic formulation of insulin that comes with the possibility of reducing if not eliminating hypoglycemic events.

    Mar 20, 2024

  • Discussions Begin On Properly Using Generative AI In Clinical Trials

    Clinical Research News | The question of whether generative artificial intelligence (AI) can play a role in clinical trials needs to be supplanted by questions of where and when it should be applied, according to a panel of experts speaking at last month’s Summit for Clinical Ops Executives (SCOPE) in Orlando.

    Mar 19, 2024

  • Navigating Wearable Integration: Key Operational Considerations in Clinical Trials

    Clinical Research News | Wearable devices are helping to transform the way clinical development programs are conducted, offering an innovative approach to data collection, patient monitoring, and endpoint measurement. The seamless integration of wearable technologies into trials requires meticulous consideration across various operational aspects.

    Mar 15, 2024

  • Site Selection With Data-Driven Decisions

    Clinical Research News | Finding the right trial site with access to a diverse patient population is challenging. While the clinical trial and research fields have made great efforts to overcome these challenges, there are still obstacles that slow down the process and frustrate researchers.

    Mar 13, 2024

  • New Vaccinology Rulebook Needed To Outsmart ‘Part-Time Pathogens’

    Clinical Research News | Researchers at University of California San Diego School of Medicine have found that the rules of vaccinology need to be reversed for Staphylococcus aureus (SA), the common and sometimes dangerous bacteria that humans encounter shortly after birth and are continuously exposed to for the remainder of their life.

    Mar 12, 2024