• uMotif, ClinOne Partner for Integrated eCOA, eConsent

    Clinical Research News | uMotif and ClinOne have announced a partnership to provide integrated electronic clinical outcomes assessments (eCOA) and electronic informed consent (eConsent) technology. While currently the two solutions remain distinct, the companies presented the news as the first step on an ongoing partnership.

    Jun 22, 2022

  • Beyond FAIR: Building Platforms for Cultural Changes of Data Sharing

    Clinical Research News | At the Bio-IT World Conference & Expo last month, Alex Sherman, Director of the Center for Innovation and Bioinformatics, Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital, explored what clinical research can look like practically beyond just checking boxes for findable, accessible, interoperable, and reusable.

    Jun 21, 2022

  • Moving Data for Clinical Trials: Standards, Systems to Link EHRs with EDC

    Clinical Research News | “Thirty to 40% of clinical trial costs are associated with actually just the manual retyping of [EHR] data [into the clinical trial system], and it leads to reporting delays and a number of other inefficiencies,” Adam Asare, chief data officer at the Quantum Leap Healthcare Collaborative/UCSF, told the Bio-IT World Conference & Expo audience last month. Asare shared a solution to that problem: a collaboration with OpenClinica that won the team a Bio-IT World Innovative Practices Award.

    Jun 16, 2022

  • PCORI Board Approves Strategic Plan, Funding for Maternal Health, Telehealth

    Clinical Research News | The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors has approved the development of new research funding opportunities, providing up to $63 million for studies on reducing maternal health inequities and up to $50 million for research on using telehealth to improve management of multiple chronic conditions.

    Jun 14, 2022

  • A 20-Year Perspective On Breast Cancer Clinical Trials

    Clinical Research News | Wider availability and uptake of mammography screening globally among women under age 60 closely align with a threefold increase in their participation in breast cancer clinical trials over the past two decades. The numbers jumped most dramatically, from 39% to 87%, between the 2005-2009 and 2010-2014 time periods. Those demographics should be prompting sponsor companies to take a fresh look at how they are designing studies in terms of who should and could be included. More can be done to improve clinical trial diversity while being mindful of the duty to protect subjects from harm.

    Jun 14, 2022

  • Side Effects Of Cancer Treatment Could Be Tempered By Intermittent Dosing

    Clinical Research News | The frequency, degree, and speed of onset of immune-related adverse events from the experimental cancer drug AMG319, an inhibitor of phosphoinositide 3-kinase δ (PI3Kδ), came as an unwelcome surprise in a recent clinical trial involving patients in the UK with head and neck cancer. But the study also served to highlight how “absolutely critical” understanding of the immune system is to the development of rational immunotherapy.

    Jun 9, 2022

  • Genetic Control Of Autoimmune Disease Mapped To Cellular Level

    Clinical Research News | The pioneering OneK1K study in Australia has identified an immune “fingerprint” of seven autoimmune disorders using single-cell RNA sequencing (scRNA-seq). The general framework, which combines the scRNA-seq data with genotype data to classify individual cells, can be applied to many different diseases.

    Jun 8, 2022

  • The Scope of Things: Jasmine Smith and Dr. Deborah Duong on the First Decentralized AI Longevity Research Network

    Clinical Research News | With the latest innovations in medicine often prohibitively expensive, Rejuve.AI’s Jasmine Smith, CEO, and Dr. Deborah Duong, CTO, help patients achieve a healthy and extended lifespan regardless of economic standing. In the latest episode of the Scope of Things podcast, they, along with podcast host, Deborah Borfitz, discuss the world’s first decentralized AI longevity research network that provides equitable health and wellness solutions.

    Jun 7, 2022

  • Guardant and IQVIA Develop Precision Oncology Platform to Normalize Clinical Data

    Clinical Research News | Innovative Practices Award | Extracting high-quality data from clinical records can be time-consuming and costly, primarily when manual abstractors are tasked with mining complex, unstructured, and lengthy documents. That’s why the scientists at Guardant Health and Linguamatics, an IQVIA company, launched a real-world evidence database called GuardantINFORM. The platform was named one of the 2022 Bio-IT World Innovative Practices award winners.

    Jun 2, 2022

  • Chasing Digital Twins: Pilot Project Tackles Cancer Patient Twins in Neuro-Oncology

    Clinical Research News | At the Bio-IT World Conference & Expo last month, a team of researchers reported on their 12-week pilot effort to build cancer patient digital twins to aid in oncologist decision-making.

    Jun 1, 2022

  • World’s First Clinical Trials Ecosystem and Marketplace About To Open

    Clinical Research News | As the world’s first clinical trial ecosystem and marketplace, ClinEco—launching in beta this summer—is designed to connect study sponsors in need of clinical trial support with the full range of clinical trial technology and service providers.

    May 31, 2022

  • Unleashing the Value of Study Data with Digital Health Technology

    Clinical Research News |In recent years, a slew of digital health technologies (DHTs), designed to collect and share data remotely, have emerged to capture more data from clinical trials. And while uptake has been slow, new guidelines and regulations from the United States and European Union are finally creating a practical framework for an operation that promises to shift the dial. But do we finally have the structures we need to build 21st-century clinical trials that hasten access to life-saving treatments? Or is there more we could be doing with data?

    May 27, 2022

  • Cloud-Based Registry for HIV Clinical Study, Next-Gen Gene and Cell Therapy Research, More

    Clinical Research News | NIAID awards $577 million to establish nine Antiviral Drug Discovery Centers; Allelica and Invitae build clinical artificial intelligence architecture for breast cancer; a new COVID-19 antibody test is used in vital pandemic research; next-generation gene and cell therapy research promote more efficient clinical trials; and more.

    May 26, 2022

  • Follow the Money: Patient-Centric Clinical Trials, Cancer Research Biomarkers, More

    Clinical Research News| Funding for virtual and hybrid clinical trial and execution models, cancer research, pharmaceutical analytics, and more.

    May 25, 2022

  • Soft Skills Critical To Clinical Trial Continuity In Ukraine

    Clinical Research News | The importance of clinical trials as a care option in Ukraine, and the unthinkable bravery of its citizens since Russia launched the first bomb on Feb. 21, were predominant themes of a recent DIA webinar on the impact of the crisis on patients and clinical development.

    May 24, 2022

  • Patient Advocacy Groups Band Together To Further Rare Disease Research

    Clinical Research News | The fast-growing Consortium for Outcome Measures and Biomarkers for Neurodevelopmental Disorders (COMBINEDBrain) represents patient advocacy organizations for individuals with rare, neurodevelopmental diseases who are disadvantaged by the small number of affected individuals and scientific brainpower to lead the way.

    May 19, 2022

  • In War-Torn Ukraine, Clinical Trials Trudge Along

    Clinical Research News | The clinical research situation in Ukraine has changed from “peaceful, predictable, and promising” a year ago to “complex, complicated, and difficult” since the Feb. 24 Russian invasion, according to Serhiy Mykhaylov, Merck’s clinical research director in the country speaking during a recent DIA webinar on the ethical dilemmas the war has created for those supporting study participants in the region. As of six months ago, Ukraine had 500 active ongoing studies.

    May 17, 2022

  • Sequencing-Based Initiative Now Exploring How Best To Return The Findings

    Clinical Research News | A pioneering program of Geisinger Health System has returned clinically actionable results from exome sequencing to a record-breaking 3,400 individuals at increased risk for potentially life-threatening conditions such as hereditary breast and colon cancers, familial hypercholesterolemia (FH), and heart disease. The MyCode Community Health Initiative, enabled by a 2014 agreement with Regeneron Pharmaceuticals, draws from participants in a sizable DNA biobank who agree to the sequencing and results reporting.

    May 11, 2022

  • Liquid Biopsy Test Shows Promise For Pediatric Glioma

    Clinical Research News | Evidence is emerging that cerebrospinal fluid (CSF) testing might be useful in clinical settings for monitoring tumor growth and treatment response in pediatric patients with diffuse midline glioma (DMG), a lethal high-grade brain tumor that is inoperable and unlikely to be cured. Only about 500 new cases get diagnosed in the U.S. in any given year, but over two-thirds of them carry the exact same mutation (H3 K27M) allowing development of an assay that analyzes cell-free tumor DNA samples using digital droplet polymerase chain reaction (ddPCR).

    May 10, 2022

  • Future-Proofing Trials with HCP Selection to Improve Source Data and Quality Management for Sponsors and CROs

    Clinical Research News | Accurate information is the foundation of any quality research study, particularly when the study is decentralized or takes a hybrid approach. For decentralized clinical trials (DCTs), the appropriate selection of healthcare practitioners is all the more important to ensure patient care and data integrity.

    May 6, 2022