• Living Biobank Of Brain Metastasis Samples Enabling ‘Personalized Medicine 2.0’

    Clinical Research News | Researchers at the CNIO (Spanish National Cancer Research Centre) are forwarding the idea that metastasis, rather than the primary tumor, should be the focus of cancer treatment, which would both further the cause of personalized medicine and generate biomarkers of sensitivity or resistance to specific drugs.

    Jan 24, 2024

  • AI-Based Platform For Detecting AFib Put To The Test In VA Facilities

    Clinical Research News | Investigators at Cedars-Sinai Medical Center are looking to minimize the biases in the data used by artificial intelligence (AI) algorithms, most recently a deep learning model trained on nearly a million electrocardiograms (ECGs) to identify people with abnormal heart rhythms. The inputs came from a pair of large Veterans Affairs (VA) hospital networks serving a highly diverse set of patients in terms of demographics and comorbidities.

    Jan 23, 2024

  • Automation Accelerates and Reduces Inconsistencies in Drug Development

    Clinical Research News | New drugs can take over a decade to receive approval. While drug development cannot be rushed, advancements in AI and automation can help life sciences organizations ensure shorter timelines to market, enhanced patient safety, and maximal resource utility.

    Jan 19, 2024

  • Digital Endpoints: Trends and Opportunities in Drug Development and Beyond

    Clinical Research News | When the Digital Medicine Society (DiMe) launched its Library of Digital Endpoints, a listing of industry-sponsored studies of new medical products or applications that use sensor-derived endpoints, there were a total of 35. Four years later, that same library now includes over 400 unique digital endpoints collected by over 60 sponsors to answer questions about the efficacy of new medical products.

    Jan 17, 2024

  • Alzheimer’s Disease Prevention Trials Require ‘More Than Science’

    Clinical Research News | Things could start looking up for randomized controlled clinical trials (RCTs) in Alzheimer’s disease (AD) prevention, which have a 25-year track record of failure, once broad biomarkers of the brain-robbing condition are found that reflect real-life risk factors.

    Jan 16, 2024

  • The Last Mile In Preventing A Deadly Hospital Infection

    Clinical Research News | The “power of the team approach” was on full display for a study designed to understand the contribution of asymptomatic carriers to the spread of Clostridioides difficile in hospitals.

    Jan 10, 2024

  • Brain Health Equity Will Take A ‘Slow-Cooking’ Approach To Alzheimer's Trials

    Clinical Research News | The “power of the team approach” was on full display for a study designed to understand the contribution of asymptomatic carriers to the spread of Clostridioides difficile in hospitals.

    Jan 9, 2024

  • Practical Considerations for Managing Cell and Gene Therapy Supply Chains

    Clinical Research News | Cell and gene therapies (CGT) have made substantial progress in recent years thanks to several breakthroughs and higher flow of funds into the space. Despite this progress, the challenges of working with living therapies remain highly complex, risk-laden, and time-consuming.

    Jan 5, 2024

  • Top Stories from 2023: CVS, Walgreens, CROs in Trial Management, Decentralized Models, More

    Clinical Research News | Last year was full of growing pains for clinical research as decentralized trial models continued to mature, AI took a more aggressive role in study planning and execution, and the player landscape continued to shake out. Here are the top stories from Clinical Research News as well as thought leaders in the industry

    Jan 4, 2024

  • Trendspotting: What’s Coming for Clinical Trials and Research in 2024

    Clinical Research News | We spoke with leaders and experts in the Clinical Research community about their predictions for 2024.

    Jan 3, 2024

  • Medidata Launches Research Alliance, BC Platforms Acquires Medexprim, Expansions, New Platforms, More

    Clinical Research News | Medidata has launched the Medidata Research Alliance; BC Platforms has acquired Medexprim, a leading European real-world data company; Velocity Clinical Research has expanded into Poland and acquired its first site, ClinMedica Research; and more.

    Dec 28, 2023

  • Follow the Money: PCORI Approves Awards For Multiple CER Studies, Advancing Women’s Reproductive Immunotherapies, Collaborations, More

    Clinical Research News | The Patient-Centered Outcomes Research Institute (PCORI) approves funding awards to support 20 new patient-centered comparative clinical effectiveness research (CER) studies; Freya Biosciences intends to advance the clinical development of its lead drug candidate; Sanofi enters a multi-year research collaboration with French pharmatech company Aqemia; and more.

    Dec 27, 2023

  • Smart Packaging Delivers Medication Adherence Insights At Pizza-Delivery Speed

    Clinical Research News | Medication adherence in phase 2 and phase 3 clinical trials is far less perfect than the 98% often cited in peer-reviewed published papers on those studies. While solutions to address it exist in the form of smart packaging, the will to adopt such technologies has been tepid, leading to widespread overdosing of trial participants—most notably those who take the drug as instructed—and, ultimately, directions for use on drug labels and unnecessary side effects once the drug hits the market.

    Dec 20, 2023

  • New Award at SCOPE Honors Innovation In Clinical Trial Site Success

    Clinical Research News | The SCOPE team just announced the finalists in the inaugural Site Innovation Award, recognizing sites and partnerships pioneering new approaches to improve clinical trials. The winner will be announced at the Summit for Clinical Ops Executives in Orlando, February 11-14, 2024.

    Dec 19, 2023

  • Planning for a Successful EMA Policy 0070 Submission

    Clinical Research News | European Medicines Agency (EMA) Policy 0070 requires the proactive publishing of clinical data submitted by pharmaceutical companies to support their marketing applications for human medicines under the centralized procedure. In other words, the EMA will publish anonymized documentation (with sensitive participant and company data protected) supporting the use of a drug on its public Clinical Data website so that anyone can read about medicines being authorized.

    Dec 15, 2023

  • Pharma’s Tech Partner Wish List

    Clinical Research News | What is pharma looking for in technology partners? That was the question posed to a panel representing Pfizer, Johnson & Johnson, GlaxoSmithKline, and AstraZeneca last month at the HLTH Conference. The answers revealed some of the trends these pharma companies expect to see in drug development and clinical trials, and the pain points they are actively addressing now.

    Dec 14, 2023

  • Participant Engagement Award Finalists Named for 2024

    Clinical Research News | The judges have announced the finalists for the annual Participant Engagement Award that is awarded each year at SCOPE, the Summit for Clinical Ops Executives. In 2024, entries from Acclinate, CISCRP, IMA Clinical Research, Oliver Patch Project, PatientWing, and SGM Alliance have progressed to the final round of consideration. The winner will be named after a live judging session with audience participation in Orlando, February 11-14.

    Dec 12, 2023

  • Navigating Cell Therapy Clinical Trial Budgets: Proactive Strategies for Success

    Clinical Research News | Clinical trial sponsors must strike a balance between budget, speed, and data quality when planning for cell therapy clinical trial costs. These costs can be difficult to predict and budget overruns often happen. However, cell therapy sponsors can better plan for clinical trial costs and lower their risk of exceeding their budgets by taking specific steps early on.

    Dec 8, 2023

  • Colleen Tenan on Respect and Mindfulness During Patient Treatment

    Clinical Research News | Clinical trials can lead to breakthroughs in research, but they can also be a viable and beneficial care option for patients. According to Colleen Purcell Tenan, M.D., medical director at Javara, clinical trials can offer resources that many patients do not have access to, such as medications not covered by insurance, counseling, and close medical follow-up.

    Dec 7, 2023

  • Prevention Strategy For Alzheimer’s Disease Now On The Horizon

    Clinical Research News | It may be possible one day soon to prevent Alzheimer’s disease, a devastating illness currently suffered by more than 30 million people worldwide. The good news comes straight from the mouth of Randall J. Bateman, M.D., professor of neurology at Washington University School of Medicine and director of the Dominantly Inherited Alzheimer Network (DIAN) and DIAN Trials Unit (DIAN-TU).

    Dec 6, 2023