• Seqster Launches Real World Data Tools on Salesforce AppExchange

    Clinical Research News | Seqster PDM has launched SeqsterOS, the operating system for patient registries and clinical studies on Salesforce AppExchange integrated directly with Salesforce Health Cloud. SeqsterOS seeks to empower life science enterprises to seamlessly integrate patient-consented Real World Data, including electronic health records (EHR), genomics, and device data, with a patient engagement layer for their clinical studies.

    Apr 12, 2022

  • EMA Endorses Biomarkers For Type 1 Diabetes Prevention Trials

    Clinical Research News | Following many years of collaborative patient-level data sharing across stakeholder groups, the European Medicines Agency (EMA) recently endorsed pancreatic islet autoantibodies as enrichment biomarkers for type 1 diabetes (T1D) trials focused on delaying or preventing the disease. The Qualification Opinion appears on both the EMA website and that of the Critical Path Institute’s (C-Path) Type 1 Diabetes Consortium (T1DC).

    Apr 8, 2022

  • Building Clinical Trial Infrastructure for Greater Diversity

    Clinical Research News | The life sciences industry has faced recent criticism for its continued challenge to boost diversity in clinical trials. Reports suggest that the US Food and Drug Administration (FDA) is currently at work on guidance that will define how the agency would interpret “adequate representation” of ethnic, racial and age diversity to increase representation of traditionally underrepresented populations in drug development. This will ensure organizations are broadening eligibility criteria through inclusive trial practices and trial design.

    Apr 8, 2022

  • Matching Japan’s Real-World Databases To Research Purposes

    Clinical Research News | Japan has a variety of databases available to researchers, but knowledge and experience is needed to understand the characteristics of each one and select wisely, according to two representatives of CMIC Group, the country’s largest contract research organization. The database options are tied to Japan’s publicly funded healthcare system that provides universal health insurance and the freedom to choose among medical institutions offering consistently high-quality, low-cost medical care.

    Apr 7, 2022

  • The Scope of Things: Craig Lipset on Decentralized Trials, the New Risk Model, and Open Doors

    Clinical Research News | The pandemic has certainly been a turning point for decentralized trials, and Craig Lipset, co-chair of the Decentralized Trials and Research Alliance (DTRA) says the reasons are clear: the industry’s understanding of risk.

    Apr 5, 2022

  • Follow the Money: Clinical Effectiveness Studies in Urinary Incontinence, Sickle Cell Disease, Mental Health

    Clinical Research News | Funding of clinical effectiveness studies related to urinary incontinence, sickle cell disease, mental health, and hypertension management, a new gene therapy for atrial fibrillation, and funding for cloud-based clinical data analytics.

    Mar 31, 2022

  • Orphan Drug Designation for ALS Treatment, Virtual Assistants in Genetic Counseling, Clinical Research Expansion in Asia

    Clinical Research News | New orphan drug designation for ALS treatment, virtual assistants in genetic counseling, AI in healthcare professional engagement, AI-powered pathology for clinical diagnostics, clinical research expansion in Asia, more.

    Mar 30, 2022

  • The Case For Tokenizing Data On Clinical Trial Participants

    Clinical Research News | Based on a lively panel discussion at the recent Summit for Clinical Ops Executives (SCOPE), it appears enthusiasm is building for the “tokenization” of clinical research participants to link information from trials to real-world data (RWD) on the same patients. The rationale includes the ability to track individuals more easily over the long haul and contextualize adverse events detected in studies, says Tim Riely, vice president of clinical data analytics at IQVIA.

    Mar 29, 2022

  • Decentralized Clinical Trials: A Revolution Improving Safety, Efficacy, and Speed

    Clinical Research News | Decentralized clinical trials (DCTs) are an exciting and fast-growing market showing no signs of slowing down. However, the shift to DCTs can present new challenges. Examples of this include ensuring patient safety throughout clinical trials and safeguarding the quality of data produced by patients.

    Mar 25, 2022

  • Consensus Definition Of ‘Treatment-Resistant Depression’ For Regulatory Trials

    Clinical Research News | Hundreds of clinical trials are underway testing therapies for treatment-resistant depression (TRD), yet until very recently there was not a clear definition of what is even being treated. But with newly proposed criteria to describe the condition, researchers and regulatory agencies have a basis for agreement that could help inform study design and potentially improve the lives of millions of people worldwide.

    Mar 23, 2022

  • Addressing the Importance of Biospecimen Collection Protocols and Quality Control Processes for Downstream Analysis

    Clinical Research News | Following a standard protocol when collecting biospecimens and conducting a quality review to confirm that you are working on appropriate samples are critically important processes for downstream analysis in medical research. If biospecimens are not collected and processed in the same way, subject to the same quality controls, diagnosis verification, and clinical data collection, researchers will not be able to determine whether data outliers are due to disease progression or process inconsistencies.

    Mar 18, 2022

  • Merck Employs Virtual Reality To Combat Burden Of Long Study Visits

    Clinical Research News | As Merck recently learned, relationships with scientific leaders and outside experts can be critical to enhancing the pediatric patient experience. That was one of the take-home messages from a case study on how the company executed on a virtual reality innovation that took first place honors during Participant Engagement Award ceremonies at the recent Summit for Clinical Ops Executives (SCOPE).

    Mar 16, 2022

  • New Pan-Cancer Prognostic Score Outperforms Existing Tools

    Clinical Research News | Roche has developed a pan-cancer prognostic scoring system useful for predicting patient survival in clinical trials and monitoring treatment progress over time. The score comprises 27 routinely collected clinical parameters and outperforms all other existing scores in every study phase, according to Anna Bauer-Mehren, data science lead for Roche Pharmaceutical Research and Early Development in Germany.

    Mar 15, 2022

  • Wholly Remote COVID-19 Drug Trial Gets High Marks On Operational Front

    Clinical Research News | A fully remote randomized clinical trial, born of necessity in the early days of the pandemic, provides evidence that the study model is viable even when testing drugs with potential heart rhythm effects. Whether the concept will be as well embraced post-pandemic remains anyone’s guess.

    Mar 9, 2022

  • Sponsors Validating Multiple Digital Endpoints For Clinical Trials

    Clinical Research News | The development and validation of novel digital endpoints in clinical trials was the subject of several case studies shared at the recent Summit for Clinical Ops Executives (SCOPE), including a pilot study of a speech-language assessment tool by Regeneron Pharmaceuticals and trials of at-home monitoring devices for gait speed and nocturnal scratching by Pfizer. Rapid adoption of wearables has provided opportunities to innovate and better understand patients and biomarkers of health abnormalities

    Mar 7, 2022

  • Fast Track Designation for Myeloid Checkpoint Inhibitor, Neuromodulation for Heart Failure, Digital Twins in Trials, More

    Clinical Research News | A first-in-class myeloid checkpoint inhibitor was granted fast track designation, clinical trial results are in for vagus nerve stimulation to treat heart failure, a clinical trial launches to assess glycosaminoglycan profiling as all-cancer detection method, and new agreements have been entered or extended to promote decentralized trials and the use of digital twins

    Mar 2, 2022

  • Rules And Roles Of Decentralized Clinical Trials Coming Into View

    Clinical Research News | The current regulatory landscape for decentralized clinical trials (DCTs), and a trio of use cases focused on medical devices and in vitro diagnostic (IVD) products, were among a bevy of presentations on the decentralized study model at the recent Summit for Clinical Research Ops Executives (SCOPE).

    Mar 1, 2022

  • Follow the Money: Immunological Therapeutics, Signal Regulatory Protein-Targeting Therapeutics, Regulatory Compliance Technology

    Clinical Research News | New pharma-focused venture cap fund, funding to drive trials for treating immunological and inflammatory diseases and shingles, and more.

    Feb 28, 2022

  • Takeda Test-Driving Clinical Trial Software Prior To Study Starts

    Clinical Research News | Takeda Pharmaceuticals is implementing a “digital visit testing site” for clinical trials, using internal volunteers to test-drive devices in a sandbox environment simulating real-world study conditions prior to their actual deployment. It’s an element of the company’s just-in-time software builds that kick off this month in “proactive preparation for the future.”

    Feb 25, 2022

  • Scoring System For Predicting ARDS Treatment Response In COVID Patients

    Clinical Research News | Researchers from Massachusetts General Hospital (MGH) and the University of Cyprus (Cyprus) have come up with a mathematical model that can predict treatment response for different subpopulations of patients with COVID-19 complicated by acute respiratory distress syndrome (ARDS) and determine biologic mechanisms of patient outcome.

    Feb 23, 2022