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  • FDA Releases New Draft Guidance on Diversity Action Plans for Clinical Studies

    Clinical Research News | Last week, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in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 Comments on the draft guidance should be submitted by September 26, 2024.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

  • 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