• 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

  • Study Establishes ENPP1 As A Biomarker For Immunotherapy Benefit

    Clinical Research News | Researchers in California have shown that breast cancer patients with RNA expression levels of ENPP1 (ectonucleotide pyrophosphatase/phosphodiesterase 1) in the bottom 50th percentile can confidently be treated with Keytruda (pembrolizumab) as well as surgery.

    Mar 7, 2024

  • Five Health Systems Picking Dandelion Health To Advance Clinical AI

    Clinical Research News | If artificial intelligence (AI) is to be as insightful as possible in advancing human health, it is not enough to have a patchwork of out-of-context data from which to draw conclusions. That is unfortunately the current situation and at the cost of lost opportunities to better treat patients, identify early biomarkers of disease, and recognize the right endpoints in clinical trials—not to mention eradicating existing biases against marginalized groups of people.

    Mar 6, 2024

  • Future Looks Bright For Decentralized Clinical Trials

    Clinical Research News | Decentralized clinical trials (DCTs) today are both more fit-for-purpose and business-as-usual than uncertain and unavoidable, as was the case during the height of the COVID-19 pandemic. Among the key challenges with DCTs are keeping sites and patients engaged, dealing with the near-constant inflow of data from digital platforms and wearable devices, and quantifying the value of various decentralized study components.

    Mar 5, 2024

  • Medidata Collaboration to Deploy Vaccine Studies, New CEO at Saama, H1 Updates to AI Toolkit, More

    Clinical Research News | Medidata and Sanofi Vaccines announced a collaboration to harness Medidata eCOA to deploy in vaccine studies; H1 has launched GenosAI Pro, a new addition to its conversational AI toolkit within Trial Landscape platform; and more.

    Feb 29, 2024

  • Follow the Money: First Circular RNA-Based Clinical Assay, Oncology Programs, More

    Clinical Research News | Circular Genomics plans to build and scale commercial operations in preparation for the launch of the world's first circular RNA-based clinical assay; NextPoint Therapeutics will advance the company’s two immuno-oncology clinical programs, NPX267 and NPX887; Accent Therapeutics will use funding to support the advancement of both lead programs—Accent’s first-in-class DHX9 inhibitor and a potentially best-in-class KIF18A inhibitor; and more.

    Feb 28, 2024