• 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

  • DE&I Initiatives May Need An Accessibility Component

    Clinical Research News | Ensuring the Black voice in clinical research was the focus of a panel discussion on diversity, equity, and inclusion (DE&I) at last week’s Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. The conversation was led by two-time cancer survivor Kimberly Richardson, president of the Black Cancer Collaborative, who vividly recalls being scolded and silenced when she questioned why her slow-growing granulosa cell tumor needed to be aggressively treated with three-drug medicinal cocktail.

    Feb 21, 2022

  • Engaging Local Communities To Support Patient-Centric Clinical Trials

    Clinical Research News | Ways to effectively engage local communities in clinical research—as trial participants, study sites, and referral partners—was a top topic of conversation at the recent Summit for Clinical Ops Executives (SCOPE) in Orlando, Fla. Karen Correa, head of global clinical operations at Takeda Pharmaceuticals, focused on tactics for educating and motivating healthcare professionals to be ongoing clinical trial referrers, while Kafayat Babajider, associate director of patient portals for Janssen Research and Development, provided a status report on its six-month-old, insights-driven My Trial Community platform.

    Feb 18, 2022

  • New Program Brings AI to Enrolling Cancer Patients in Trials

    Clinical Research News | A leader in precision medicine and AI-enabled clinical trial enrollment for oncology patients has launched a program designed to simplify the enrollment process and open clinical trial access to all cancer patients. The goal of Massive Bio’s new 100K Singularity Program, which uses artificial intelligence (AI) and real-time access, is to transform the current clinical trial enrollment process.

    Feb 16, 2022

  • Inclusive Research Is Good For Business As Well As Science

    Clinical Research News | Inclusive clinical research matters to patients, shapes good science, and is imperative to business success, according to Meghan McKenzie, principal inclusion, internal partnering, in Genetech’s Chief Diversity Office. How to go about increasing diversity in clinical trials was the focus of her keynote presentation at last week’s Summit for Clinical Op Executives (SCOPE) in Orlando, Florida.

    Feb 15, 2022

  • Novartis Has An Evidence-Based Connected Health Vision

    Clinical Research News | Novartis has plans to develop one or more “connected health” solutions—a universe that includes connected devices, wearables, and software as medical devices (SaMD)—to be part of its drug program over the next five years. Its fledging digital health platform will be putting those tools in the hands of clinicians, patients, and researchers to improve the overall healthcare experience and access to trials, according to the keynote last week at the Summit for Clinical Ops Executives (SCOPE).

    Feb 14, 2022