• Policy Change Alone Won’t Achieve Equity in Clinical Trial Participation

    Clinical Research News | A federal mandate that all state Medicaid programs cover the routine costs of participation in clinical trials could have a “meaningful impact” on equity in study participation. The focus should now be on ensuring states collaborate with frontline clinicians to ensure they are aware of the latest Medicaid policy change, and that those who “disproportionately treat patients from minoritized communities are plugged into relevant trial networks and able to refer patients to [applicable] trials.”

    Aug 8, 2024

  • Safe and Intriguing ‘Nature’s Drugs’ Taking on Complex Diseases

    Clinical Research News | The cost of bringing a drug to market has, by some estimates, ballooned to $3 billion and the central problem could be the “misapplication of technology.” Since completion of the Human Genome Project, the focus had shifted heavily toward orphan drugs with a single genetic target, suitable only to highly targeted genetic technology platforms.

    Aug 6, 2024

  • Leveraging Advanced Technologies for Clinical Trial Success

    Clinical Research News | Clinical trials are a crucial step to advancing healthcare and bringing new treatments to patients. However, drug development is a lengthy, expensive, and high-risk proposition, and, according to PhRMA, a process that can take up to 15 years with an average cost exceeding $2 billion per new medicine.

    Aug 2, 2024

  • Trials ‘Still Largely White and Largely Male’ Due to Hidden Biases

    Clinical Research News | Randomized clinical trials (RCTs) may need some serious revamping, based on mounting evidence of systemic biases afflicting the entire enterprise. Despite decades of efforts to realize equitable participation by marginalized groups, notably women and people of color, RCTs are “still largely white and largely male.”

    Jul 31, 2024

  • Youth Diabetes Researchers Invited to Dip Into POND, Make a Hypothesis

    Clinical Research News | Soaring rates of youth prediabetes and diabetes over the past few decades have prompted a multidisciplinary team of experts from the Icahn School of Medicine at Mount Sinai (ISMMS) to create a dataset unifying potentially important clues about how to personalize interventions and devise better prevention strategies.

    Jul 30, 2024

  • Walgreens Receives Project Award, Oracle Announces New AI Capabilities for Trials, N-Power, Merck Collaborate on Oncology Clinical Research, More

    Clinical Research News | Walgreens received a project award valued up to $25 million through the Rapid Response Partnership Vehicle to conduct a Phase IV observational clinical study focused on assessing Correlates of Protection; Oracle announced new capabilities in its AI-supported Oracle Argus and Safety One Intake solutions to help life science organizations meet evolving regulatory requirements and the rising volume of adverse event case workloads; Merck and N-Power Medicine has collaborated to enable a greater number of oncologists—and the patients they care for—to participate in clinical research; and more.

    Jul 25, 2024

  • Cardurion Pharmaceuticals’ Cardiovascular Trials, Cancer Resisting Monoclonal Antibodies, More

    Clinical Research News | Cardurion Pharmaceuticals raises $260 million to support later-stage clinical trials with the company’s two lead drug candidates; CatalYm adds $150 million for phase 2b studies targeting checkpoint-naive and second-line treatment settings for solid tumors; and more.

    Jul 24, 2024

  • Revolutionizing Clinical Trials with Generative AI

    Clinical Research News | The rapid advancements in artificial intelligence, particularly generative AI (GenAI), are enabling broader technology acceleration and driving a significant transformation in the healthcare industry. This democratization of AI capabilities opens the door to widespread innovation across clinical trials and drug development and represents a unique change in thinking compared to previous technological advancements.

    Jul 19, 2024

  • Children’s Hospital Colorado Launches Research Institute For Children’s Health

    Clinical Research News | After more than 50 years of working together, Children’s Hospital Colorado has established a formal partnership with University of Colorado Anschutz Medical Campus to launch the Colorado Child Health Research Institute. The Institute aims to unite more than 500 physician-scientists, researchers, nurse-scientists, and other investigators and enable them to develop treatments that improve the lives and health of child patients.

    Jul 17, 2024

  • Digital Endpoints Gaining Ground in Industry-Sponsored Trials

    Clinical Research News | A recent analysis of interventional clinical trials by the Tufts Center for the Study of Drug Development (CSDD) has found that use of digital endpoints has been growing rapidly since 2015 with drug developers now initiating an average of about 35 such studies each year. News of the uptick isn’t entirely surprising, given mounting evidence that the approach can improve operational performance and ease patient burdens in clinical trials and in clinical practice, while [potentially] yielding financial net benefits to developers.

    Jul 16, 2024

  • Fresh Take on How to Conduct Rare Disease Clinical Trials

    Clinical Research News | A boutique clinical trial program launched less than two years ago to redirect the way clinical trials for rare diseases are conducted now knows it “vastly underestimated” demand. Uncommon Cures, a privately held U.S. company, already has eight signed contracts, is negotiating five more, and is actively talking with more than 50 clients about possible trials.

    Jul 11, 2024

  • Proscia, Nucleai Partner to Link Digital Pathology, AI-Predictive Biomarker Platforms

    Clinical Research News | Proscia and Nucleai are partnering to integrate Nucleai’s predictive biomarker solutions into Proscia’s Concentriq software platform and make them available as part of Proscia’s AI-enabled pathology portfolio to better inform patient care.

    Jul 9, 2024

  • FDA Releases New Draft Guidance on Diversity Action Plans for Clinical Studies

    Clinical Research News | Last week, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Comments on the draft guidance should be submitted by September 26, 2024.

    Jul 2, 2024

  • Follow the Money: Cholesterol-Lowering Monoclonal Antibody, Alzheimer’s Therapy, More

    Clinical Research News | Marea Therapeutics progresses their MAR001 Phase 2 development plan and further advancement of additional pipeline programs; Alzheon plans to complete their pivotal Phase 3 program and prepare commercialization of their oral Alzheimer’s therapy with runway into 2026; more.

    Jun 27, 2024

  • New SAS Clinical Products, Payment Solution from IQVIA, Certara Platform Simplifies Medical Writing, More

    Clinical Research News | SAS has expanded its portfolio to include SAS Clinical Acceleration Repository and SAS Data Maker for synthetic data; Seqster and Thread partner to accelerate access to real-world data for patients, researchers, and life science enterprises; Certara unveiled its next-generation CoAuthor regulatory writing software for medical writers; more.

    Jun 26, 2024

  • ClinEco Launches "Ask a ClinEco Luminary" Program for Expert Insights

    Clinical Research News | ClinEco has launched the "Ask a ClinEco Luminary" program, offering its members direct access to leading experts in the clinical trials industry. The initiative aims to foster progressive dialogue and provide reliable expert advice to drive meaningful discourse within the ClinEco community.

    Jun 25, 2024

  • The Seemingly ‘Wicked Problems’ Keeping Pregnant and Lactating Women From Participating in Clinical Trials Might be Fixable

    Clinical Research News | For anyone who has ever given birth, it will come as little surprise that few drugs have been approved for use during pregnancy and the breastfeeding period—even for something as basic as managing the symptoms of the cold or flu. The bigger shock may be that the absence of medicines extends to health conditions affecting pregnancy and birth such as postpartum hemorrhage and pre-eclampsia, two of the leading causes of maternal death.

    Jun 20, 2024

  • Tax Rebates ‘Icing on the Cake’ for Biotechs Doing Phase 1 Trials Down Under

    Clinical Research News | A trailblazing federally qualified health center (FQHC) in Nevada is now in the business of conducting industry-sponsored clinical trials, which may foreshadow more widespread interest among the nation’s roughly 1,400 nonprofit FQHCs enabling access to care for low‐income, racially diverse, and medically underserved populations.

    Jun 19, 2024

  • Pioneering Health Center Brings Clinical Trials to People Who Need Them Most

    Clinical Research News | A trailblazing federally qualified health center (FQHC) in Nevada is now in the business of conducting industry-sponsored clinical trials, which may foreshadow more widespread interest among the nation’s roughly 1,400 nonprofit FQHCs enabling access to care for low‐income, racially diverse, and medically underserved populations.

    Jun 18, 2024

  • Clinical Trials Adrift in the Age of Social Media

    Clinical Research News | Many forces outside of the healthcare setting shape people’s decisions about whether to join or stay in a clinical trial or comply with study-related requirements. While no strong evidence exists that influencers on social media are impacting the integrity of trials, it has become self-evident that they have the power to undermine the authority of traditional sources of information and their sway is therefore an issue “very deserving of our attention."

    Jun 13, 2024