• IVDR Creating ‘Significant Challenges’ For Global Precision Medicine Trials

    Clinical Research News | The impact of Europe’s In Vitro Diagnostic Medical Devices Regulation on global trials for precision medicine was shared at the recent Next Generation Dx Summit held in Washington, DC. IVDR is finally coming into force and creating “significant challenges” for pharmaceutical companies sponsoring studies involving biomarker testing on EU patient samples.

    Sep 13, 2022

  • The Hospital’s Evolving Role in Complementing Clinical Trials

    Clinical Research News | People of color comprise approximately 39 percent of the U.S. population but typically only represent 2 to 16 percent of trial patients. Unlocking the clinical data captured by hospitals and health systems may be the key to closing gaps in care.

    Sep 9, 2022

  • DTRA Releases Lexicon for Decentralized Clinical Research

    Clinical Research News | The Decentralized Trials & Research Alliance announced the release of the DTRA Glossary, an interactive lexicon to provide a consistent vocabulary for and improve the global adoption of decentralized research.

    Sep 8, 2022

  • Moving the Needle: How the Practice of Pharmacy Addresses Key Issues in Clinical Research

    Clinical Research News | In the latest episode of the Scope of Things podcast, Founder and CEO Gerald Finken speaks with host Deborah Borfitz about RxE2, a community-based decentralized trial technology company spearheaded by pharmacists, designed to integrate the practice of pharmacy into every aspect of clinical trials.

    Sep 6, 2022

  • How Patient-Centered Strategies Are Transforming Clinical Trials

    Clinical Research News | Patient centricity is a term on everyone’s lips right now. The life science sector is coming round to the idea that, by putting the needs of the patient at the heart of drug development, we can improve the patient experience and reduce development timelines while creating significant business value.

    Sep 2, 2022

  • The NIH’s Strategic Plan to Cure Hepatitis B, Merck’s New Clinical Research Data Platform, More

    Clinical Research News | An ultra-sensitive assay accurately measures antibodies against SARS-CoV-2; a single-vendor gene-to-mRNA service delivers custom mRNA within six to eight weeks; Mayo Clinic manufactures biotherapeutics for rare and complex conditions; and more.

    Aug 31, 2022

  • Follow the Money: Cross-Disciplinary Viral Emergence Research Institute, New Anti-Aging Research Initiative, More

    Clinical Research News | Funding for Johns Hopkins international tuberculosis research project, new yellow fever, rabies, and chronic hepatitis B vaccines, multiple sclerosis research grants, and more.

    Aug 30, 2022

  • When Will We Solve the Patient Engagement Dilemma?

    Clinical Research News | Adopting countless tools to engage patients and capture information in trials limits the opportunity to share common learnings, establish standard procedures, or gain economies of scale through replication across studies. With standardized processes and workflows, sponsors can reduce implementation complexity and create a repeatable model across most studies with minor changes.

    Aug 26, 2022

  • ‘Laboratory For Motion’ Uses AI To Turn Movements Into Clinical Endpoints

    Clinical Research News | Movement can now be used as a functional biomarker and endpoint for all sorts of treatments—including orthopedic surgery for bad knees and hips, spinal cord stimulation for debilitating back pain, weight-loss programs for obesity, and even laser surgery for glaucoma.

    Aug 25, 2022

  • AI Could Help Spot Difficult-To-Detect Pancreatic Cancer Sooner

    Clinical Research News | Radiomics-based machine learning models have been shown to do an impressive job of detecting pancreatic cancer on pre-diagnostic CT scans several months before symptoms appear, suggesting that one day the disease will more often be diagnosed at a stage where a surgical cure may be possible.

    Aug 23, 2022

  • Survey Suggests Alzheimer’s Research Is Missing the Boat

    Clinical Research News | A research team is advocating for a more data-driven approach to Alzheimer’s research where sets of biological pathways get grouped with mechanisms the body itself uses to ward off the disease.

    Aug 18, 2022

  • Long COVID and Chronic Fatigue Syndrome Have A Lot In Common

    Clinical Research News | Evidence is emerging that long COVID (formally “post-acute sequelae SARS-CoV-2 infection,” or PASC) bears a striking, molecular-level resemblance to the disabling and complex illness now known as myalgic encephalomyelitis/chronic fatigue syndrome.

    Aug 16, 2022

  • A Blended Solution–How Midsize Pharmaceutical and Biotech Companies Can Optimize the Delivery of Their Clinical Trials

    Clinical Research News | Large biopharma companies use two outsourcing models to deliver their clinical trial portfolios: CRO and FSP. But what about mid-sized companies? As they experience significant growth in development, have their operating models grown with them?

    Aug 12, 2022

  • Classification System For Colorectal Cancer Needs An Update

    Clinical Research News | A multi-national team of clinicians and scientists has determined that the consensus molecular subtype (CMS) classification of colorectal cancer needs updating to better reflect the molecular underpinnings of the disease.

    Aug 11, 2022

  • GA4GH Phenopackets Standard Published By ISO

    Clinical Research News | The International Organization for Standardization (ISO) has published Phenopackets, a standard initially developed by the Global Alliance for Genomics and Health and championed at ISO under the Canadian Mirror Committee to ISO/TC215/SC1 Genomics informatics, and supported by the Standards Council of Canada.

    Aug 10, 2022

  • Online ‘Biclustering’ Tool Stratifies Patients To The Molecular Level

    Clinical Research News | Researchers in Germany have developed a web-based tool, powered by machine learning, which extracts disease subtypes from large pools of patient data. The goal is more precise and robust predictions about molecular signatures that can serve as a starting point for investigating disease heterogeneity.

    Aug 9, 2022

  • Walgreens’ Decentralized Clinical Trial Future

    Clinical Research News | In June, Walgreens launched its clinical trial business in an effort to combine the company’s vast foundation of patient insights, partner-enabled health and technology capabilities, and in-person and virtual care options to break through barriers to engaging broader and more diverse communities.

    Aug 4, 2022

  • Finding the Silver Lining: Data and Knowledge Sharing Through Research Data Networks

    Clinical Research News | Research communities face tremendous challenges in creating and acquiring FAIR data. In the latest Scope of Things podcast episode, Dipak Kalra, president of i~HD, talks about research data networks, navigating the pandemic, and new data regulations from the European Commission.

    Aug 2, 2022

  • Leveraging Non-Wrist Wearables for Healthcare and Clinical Trials

    Clinical Research News | Wearables enable us to measure and derive any number of digital clinical endpoints, but their value—and challenge—lies in having those endpoints validated and broadly accepted. An open-source approach to algorithm development is crucial, especially involving non-wrist wearable use cases.

    Jul 29, 2022

  • PTSD Adaptive Platform Trial, Long COVID Phenomics Research, More

    Clinical Research News | The American Heart Association hosts a six-month challenge testing heart failure and the social determinants of health; research accelerates for an NGS-based diagnostic test to identify cancer; a multi-year project enlists 10,000 people 95 and older to explore the biological and genetic underpinnings of exceptional longevity; and more.

    Jul 28, 2022