• Brain Stimulation Device Could Make Precision Mental Health A Reality

    Clinical Research News | In the not-too-distant future, disorders of the brain could be treated with the same precision as heart disease and cancer. The means will be a therapeutic brain-computer interface (BCI) the size of a small blueberry for people suffering from treatment-resistant depression that uses a similar type of implant technology as Elon Musk’s Neuralink for helping paralyzed people speak.

    May 21, 2024

  • Challenges Facing Cell & Gene Therapy Clinical Trials

    Clinical Research News | Clinical trials are the bedrock for developing advanced treatments within the life-saving field of cell and gene therapy. Despite significant strides, these trials encounter multi-faceted challenges that threaten to impede the progress of important new therapies.

    May 17, 2024

  • Clinical Trial Underway for New-and-Improved Prostate Cancer Test

    Clinical Research News | Researchers at the University of Michigan (U-M) have developed a urine test for prostate cancer known as MyProstateScore 2.0 (MPS2), now a property of spinoff LynxDx, which they expect to significantly improve upon the performance of existing assays by focusing on clinically significant cancers and capturing more biomarkers in a single test.

    May 14, 2024

  • How Patient-Mediated Research Can Disrupt Life Sciences

    Clinical Research News | The life science industry is changing. There are growing calls for real-world evidence (RWE) and feedback from patients (PROs). Rare diseases are growing in importance, and there is increasing recognition of equity as an ethical and drug-efficacy necessity.

    May 10, 2024

  • Functional Precision Medicine Shows Promise for Kids With Tough Cancers

    Clinical Research News | A cancer researcher at Florida International University (FIU) has developed a functional precision medicine (FPM) approach to oncology treatment decision-making that combines genomic profiling with drug sensitivity testing on patient-derived tumor cells. Children with relapsed or refractory cancers are among the initial beneficiaries.

    May 9, 2024

  • Thermo Fisher on the Rise of Next-Generation Sequencing CDx

    Clinical Research News | In oncology, it is well appreciated that time is life. Diagnostics are therefore valuable not just to determine the disease state of patients but how best to treat them, says Jane Li, senior director of oncology, pharma, and CRO partnerships related to clinical sequencing at Thermo Fisher Scientific.

    May 7, 2024

  • eConsent In Decentralized Clinical Trials - A Path To Participant Empowerment And Transparency

    Clinical Research News | Electronic consent, or eConsent, has emerged as a cornerstone in the decentralized clinical trials (DCTs) landscape. Central to this is the Food and Drug Administration’s (FDA) resounding endorsement of electronic methodologies for obtaining informed consent from clinical trial participants.

    May 3, 2024

  • 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