• Watching the State of Clinical Trial Data Compliance

    Clinical Research News | Until relatively recently, clinical-trial submissions in the EU had to be made separately to each applicable member-state’s authority. The process was inefficient and laborious, resulting in a lot of complaints from clinical-research organizations. On January 31, 2022, the EU Clinical Trials Regulation came into effect.

    Jun 11, 2024

  • ‘Continuity’ and Why It’s Now Critical for Successful Ophthalmic Clinical Trials

    Clinical Research News | Ophthalmic clinical trials are expanding in global reach, incorporating a wide range of geographical areas, sites, personnel, and imaging technologies. Maintaining data integrity, imaging reliability, process efficiency, and regulatory compliance across these multi-faceted environments can be quite challenging—and is why continuity across image collection, processing, and management is now a fundamental “must-have” for ophthalmic clinical trial success.

    Jun 7, 2024

  • AI Model Estimates Treatment Effect on Par With Clinical Trials

    Clinical Research News | Researchers at The Ohio State University (OSU) have been using artificial intelligence (AI) for several years now to emulate clinical trials by crunching real-world data (RWD). In their latest computational feat, they succeeded in precisely estimating results of randomized clinical trials comparing the effectiveness of two treatments for reducing the risk of stroke after coronary artery disease.

    Jun 6, 2024

  • Blood Test Could Improve Diagnosis of Severe Strokes on a Global Scale

    Clinical Research News | Researchers at The Ohio State University (OSU) have been using artificial intelligence (AI) for several years now to emulate clinical trials by crunching real-world data (RWD). In their latest computational feat, they succeeded in precisely estimating results of randomized clinical trials comparing the effectiveness of two treatments for reducing the risk of stroke after coronary artery disease.

    Jun 4, 2024

  • American Clinical Research Services Acquires Elixia, Oxford BioDynamics, King’s College London Collaborate, Recursion’s Supercomputer Ranked, More

    Clinical Research News | American Clinical Research Services has acquired Elixia; Oxford BioDynamics and King's College London are teaming up in the immediate follow up of the APIPPRA trial, the largest RA prevention trial to date; Recursion’s BioHive-2 was dubbed No. 35 on the latest TOP500 list of the world’s fastest supercomputers; more.

    May 29, 2024

  • Follow the Money: Blackstone Launches Portfolio Company, PCORI Approves Funds for CER Studies, Funds Gifted for Alzheimer’s Research, More

    Clinical Research News | Blackstone launches the Blackstone Life Sciences portfolio company Uniquity Bio, a clinical-stage drug development company focused on immunology and inflammation; the Patient-Centered Outcomes Research Institute secures approval of funding awards to support new patient-centered comparative clinical effectiveness research studies; Laurence Belfer gifts funds to the University of Texas MD Anderson Cancer Center to strengthen neurodegeneration research through the Belfer Neurodegeneration Consortium, a transformative multi-institutional initiative to advance the study and treatment of Alzheimer’s disease; more.

    May 28, 2024

  • The Risk-Based Data Management (RBDM) Revolution

    Clinical Research News | The clinical trials landscape is evolving with more data, increased investment in personalized medicines and a shift toward decentralized and hybrid clinical trials. At the same time, the industry is attempting to become more efficient and harness new technologies and data science in operations.

    May 24, 2024

  • Pan-RAS Inhibitor Offers Hope of Improved Pancreatic Cancer Prognosis

    Clinical Research News | A consortium of pancreatic cancer researchers sharing information in real time has shown that an oral pan-RAS inhibitor known as RMC-7977, developed by Revolution Medicines, effectively targets the common cancer-causing RAS proteins while minimally impacting normal cells—and did so across a comprehensive range of preclinical models in a series of similar experiments.

    May 22, 2024

  • 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